Trial no.:	PACTR202608587329540	Date of Registration:	13/08/2026
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Effect of periodontal therapy on mouthrinse active matrix metalloproteinase-8 in patients with prediabetes in delaying the switch to type 2 diabetes.

Official scientific title

Mouthrinse aMMP-8 activity in Prediabetes and the effect of periodontal therapy in delaying the switch to type 2 diabetes.

Brief summary describing the background and objectives of the trial

DM and periodontal inflammation are closely connected; both releasing inflammatory markers like interleukin-6 and C-reactive protein. Periodontitis also produces active-matrix metalloproteinases-8 (aMMP-8), mainly from neutrophils. Both conditions are difficult to detect early, but point-of-care mouthrinse kits permit rapid, non-invasive quantification of aMMP-8 for improved diagnosis and treatment. The research will use a prospective cohort design with 87 adult patients at the Lagos University Teaching Hospital (LUTH), categorized into prediabetes, diabetes, and age and gender-matched control groups. The study will determine the effect of non-surgical periodontal therapy (NSPT) on mouth rinse aMMP-8, serum hsCRP and periodontal parameters in prediabetes, diabetes and age and gender-matched controls with normal glycemic levels after three months post-NSPT. Additionally, it will assess the correlation between periodontal clinical parameters, aMMP-8, glycated hemoglobin and hsCRP. Results will be assessed at baseline and three months after periodontal therapy..

Type of trial

Observational

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

1. Diabetes and Periodontitis 2. Prediabetes and Periodontitis 3. Normoglycemia and Periodontitis

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

06/01/2022

Actual trial start date

19/01/2022

Anticipated date of last follow up

24/12/2023

Actual Last follow-up date

13/10/2023

Anticipated target sample size (number of participants)

Actual target sample size (number of participants)

112

Recruitment status

Completed

Publication URL

https://pmc.ncbi.nlm.nih.gov/articles/PMC12025252/

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Non-randomised		Allocation Sequence/Code was not concealed	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Systemic antibiotics and Scaling and root planing with Chlorhexidine mouthrinse	Caps Amoxicillin 500mg 8 hourly and Tabs Metronidazole 400mg 8 hourly, and adjunctive irrigation with 0.2% Chlorhexidine mouthrinse	Systemic antibiotics were prescribed for 5 days	Systemic antibiotics were prescribed for 5 days, along with full mouth disinfection in form of scaling and root planing of periodontal pockets ≥ 4mm, and subgingival irrigation using 0.2% Chlorhexidine mouthrinse.	56
Control Group	Scaling and root planing with Chlorhexidine mouthrinse and No Systemic antibiotics	No systemic antibiotics	Not applicable	Only full mouth disinfection in form of scaling and root planing of periodontal pockets ≥ 4mm, and subgingival irrigation using 0.2% Chlorhexidine mouthrinse.	56	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1. Subjects ≥ 18 years with prediabetes, diabetes and normoglycemia. 2. Subjects with evidence of clinical periodontal inflammation (periodontitis (all stages and grades) based on the case definition from the 2017 Classification of Periodontal and Peri-implant diseases and conditions.	1. Subjects with known history of chronic inflammatory conditions including osteoarthritis, rheumatoid arthritis and pregnancy. 2. Subjects with a history of immunosuppression (e.g HIV) or are on immunosuppressive drugs. 3. Subjects who have received periodontal treatment in preceding six months prior to presentation. 4. Subjects who have used tobacco in the last 3 months. 5. Subjects who do not give their informed consent to participate in the study.	80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	84 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

06/01/2022

College of Medicine University of Lagos Health Research Ethics Committee

Ethics Committee Address
Street address	City	Postal code	Country
2nd Floor Biomedical Engineering Block College of Medicine University of Lagos, Idi-Araba, Lagos	Lagos	100254	Nigeria

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Mouthrinse active matrix metalloproteinase - 8 / aMMP-8 level	At baseline and three months post-intervention
Secondary Outcome	Periodontal clinical parameters scores - probing depth, clinical attachment loss, plaque index, oral hygiene index score, bleeding on probing percentage, gingival index, periodontal inflamed surface area	At baseline and three months post-intervention
Secondary Outcome	Glycated hemoglobin level - HbA1c	At baseline and three months post-intervention
Secondary Outcome	Serum high sensitivity C-reactive protein level - hsCRP	At baseline and three months post-intervention
Secondary Outcome	Body Mass Index/ BMI	At baseline and three months post-intervention.

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Periodontology and Endocrinology clinics of the Lagos University Teaching Hospital	Ishaga Road, Idi-Araba, Surulere, Lagos, Nigeria	Lagos	100254	Nigeria

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
University of Lagos Central Research Committee Unilag CRC	Research and Innovation Building behind the Ade-Ajayi Auditorium on the UNILAG Campus, Akoka-Yaba	Lagos	101017	Nigeria

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	University of Lagos Central Research Committee	Research and Innovation Building behind the Ade-Ajayi Auditorium on the UNILAG Campus, Akoka-Yaba	Lagos	101017	Nigeria	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Prof. Olufemi Fasanmade	College of Medicine University of Lagos, Idi-Araba, Surulere	Lagos	101014	Nigeria
Prof. Timo Sorsa	Department of Oral and Maxillofacial Diseases, University of Helsinki and Helsinki University Hospital FI-00014, Helsinki	Helsinki	FI-00014	Finland
Prof Solomon Nwhator	Department of Preventive and Community Dentistry Faculty of Dentistry, College of Health Sciences Obafemi Awolowo University	Ile Ife	220005	Nigeria
Dr. Oladunni Ogundana	College of Medicine University of Lagos, Idi-Araba, Surulere	Lagos	101014	Nigeria
Dr. Obiefuna Ajie	College of Medicine University of Lagos, Idi-Araba, Surulere	Lagos	101014	Nigeria

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Kehinde Umeizudike	kumeiz09@gmail.com	+2348055451018	Department of Preventive Dentistry, Faculty of Dental Sciences, College of Medicine, University of Lagos, Idi-Araba, Surulere
City	Postal code	Country	Position/Affiliation
Lagos	101014	Nigeria	Professor of Periodontology
Role	Name	Email	Phone	Street address
Scientific Enquiries	Solomon Nwhator	sonwhator@oauife.edu.ng	+2349021074527	Department of Preventive and Community Dentistry Faculty of Dentistry College of Health Sciences Obafemi Awolowo University
City	Postal code	Country	Position/Affiliation
Ile Ife		Nigeria	Head of Department of Preventive and Community Dentistry Faculty of Dentistry College of Health Sciences Obafemi Awolowo University
Role	Name	Email	Phone	Street address
Public Enquiries	Olufemi Hodefe	pohodefe@cmul.edu.ng	+2348028642463	College of Medicine University of Lagos Idi-Araba Surulere
City	Postal code	Country	Position/Affiliation
Lagos		Nigeria	Member CMULHREC

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	The de-identified IPD will be made available.	Informed Consent Form,Statistical Analysis Plan,Study Protocol	After publication, and no end date.	Researchers who provide a methodologically sound proposal.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	Yes		05/05/2026	16/04/2025
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:
Result - 05/05/2026
Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks	https://drive.google.com/file/d/1LTTgv9MIEW_rbLkBT0GYQdCovLeHa812/view?usp=drive_link

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	07/07/2026	No change	DM and periodontal inflammation are closely connected; both releasing inflammatory markers like interleukin-6 and C-reactive protein. Periodontitis also produces active-matrix metalloproteinases-8 (aMMP-8), mainly from neutrophils. Both conditions are difficult to detect early, but point-of-care mouthrinse kits permit rapid, non-invasive quantification of aMMP-8 for improved diagnosis and treatment. The research will use a prospective cohort design with 87 adult patients at the Lagos University Teaching Hospital (LUTH), categorized into prediabetes, diabetes, and age and gender-matched control groups. The study will determine the effect of non-surgical periodontal therapy (NSPT) on mouth rinse aMMP-8, serum hsCRP and periodontal parameters in prediabetes, diabetes and age and gender-matched controls with normal glycemic levels after three months post-NSPT. Additionally, it will assess the correlation between periodontal clinical parameters, aMMP-8, glycated hemoglobin and hsCRP. Results will be assessed at baseline and three months after periodontal therapy.	DM and periodontal inflammation are closely connected; both releasing inflammatory markers like interleukin-6 and C-reactive protein. Periodontitis also produces active-matrix metalloproteinases-8 (aMMP-8), mainly from neutrophils. Both conditions are difficult to detect early, but point-of-care mouthrinse kits permit rapid, non-invasive quantification of aMMP-8 for improved diagnosis and treatment. The research will use a prospective cohort design with 87 adult patients at the Lagos University Teaching Hospital (LUTH), categorized into prediabetes, diabetes, and age and gender-matched control groups. The study will determine the effect of non-surgical periodontal therapy (NSPT) on mouth rinse aMMP-8, serum hsCRP and periodontal parameters in prediabetes, diabetes and age and gender-matched controls with normal glycemic levels after three months post-NSPT. Additionally, it will assess the correlation between periodontal clinical parameters, aMMP-8, glycated hemoglobin and hsCRP. Results will be assessed at baseline and three months after periodontal therapy..
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Study Design	Intervention assignment	14/07/2026	The interventions were the same for the groups	Parallel: different groups receive different interventions at same time during study	Single Group
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Study Design	Intervention assignment	05/08/2026	I have revised the study design by selecting the parallel group instead of single group to reflect the 2 groups in the study. Thank you.	Single Group	Parallel: different groups receive different interventions at same time during study
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Disease(s)	18/05/2026	Disease(s) or condition(s) was changed to "Periodontitis", in response to the comments to review the intervention names for all the groups.	Oral Health	Other
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Other disease	18/05/2026	Disease(s) or condition(s) was changed to 'Periodontitis', in response to the comments to review the intervention names for all the groups.		Periodontitis
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Other disease	18/05/2026	Disease(s) or condition(s) was changed to "Periodontitis", in response to the comments to review the intervention names for all the groups.	Periodontitis	Periodontitis.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Other disease	18/05/2026	Disease(s) or condition(s) was changed in response to the comments to reflect the intervention names for all the groups.	Periodontitis.	Diabetes and Periodontitis, Prediabetes and Periodontitis, Normoglycemia and Periodontitis
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Other disease	27/05/2026	We have since changed the Intervention names to the following listed. The change is in response to the Review comments: "Please review the intervention names for all the groups, we do not want "conditions or disease."&#x0D".	Diabetes and Periodontitis, Prediabetes and Periodontitis, Normoglycemia and Periodontitis	1. Diabetes and Periodontitis 2. Prediabetes and Periodontitis 3. Normoglycemia and Periodontitis
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Other disease	14/07/2026	N/A	1. Diabetes and Periodontitis 2. Prediabetes and Periodontitis 3. Normoglycemia and Periodontitis	1. Diabetes and Periodontitis 2. Prediabetes and Periodontitis 3. Normoglycemia and Periodontitis
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	27/05/2026	This is in response to Review Comments to review the intervention names for all the groups, and remove "conditions or disease".		Experimental Group, Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouthrinse., While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 40,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	14/07/2026	The change is in response to the review comments to differentiate the intervention names for all the groups		Experimental Group, Scaling and root planing and Chlorhexidine mouthrinse and Systemic antibiotics, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouthrinse., While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 40,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	14/07/2026	The change is in response to the review comments to differentiate the intervention names for all the groups		Control Group, Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 16, Active-Treatment of Control Group
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	14/07/2026	The change is in response to the review comments to differentiate the intervention names for all the groups		Experimental Group, Systemic antibiotics and Scaling and root planing and Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouthrinse., While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 40,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	14/07/2026	The change is in response to the review comments to differentiate the intervention names for all the groups	Experimental Group, Systemic antibiotics and Scaling and root planing and Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouthrinse., While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 40,	Experimental Group, Systemic antibiotics and Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouthrinse., While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 40,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	22/07/2026	The change is in response to the review comments to differentiate the intervention names for all the groups	Experimental Group, Systemic antibiotics and Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouthrinse., While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 40,	Experimental Group, Systemic antibiotics and Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouthrinse., While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 56,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	22/07/2026	The change is in response to the review comments to differentiate the intervention names for the groups	Experimental Group, Systemic antibiotics and Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouthrinse., While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 56,	Experimental Group, Systemic antibiotics and Scaling and root planing with Chlorhexidine mouthrinse, Caps Amoxicillin 500mg 8 hourly and Tabs Metronidazole 400mg 8 hourly, and adjunctive irrigation with 0.2% Chlorhexidine mouthrinse , Systemic antibiotics were prescribed for 5 days, Systemic antibiotics were prescribed for 5 days, along with full mouth disinfection in form of scaling and root planing of periodontal pockets ≥ 4mm, and subgingival irrigation using 0.2% Chlorhexidine mouthrinse., 56,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	27/05/2026	This is in response to Review Comments to review the intervention names for all the groups, and remove "conditions or disease".	Experimental Group, Diabetes , Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally. Participants with severe periodontitis ≥ 6mm were placed on systemic antibiotics, in form of oral amoxicillin 500 mg and metronidazole 400 mg eight hourly for five days. , 56,	Experimental Group, Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally. Participants with severe periodontitis ≥ 6mm were placed on systemic antibiotics, in form of oral amoxicillin 500 mg and metronidazole 400 mg eight hourly for five days. , 56,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	14/07/2026	The change is in response to the review comments to differentiate the intervention names for all the groups	Experimental Group, Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally. Participants with severe periodontitis ≥ 6mm were placed on systemic antibiotics, in form of oral amoxicillin 500 mg and metronidazole 400 mg eight hourly for five days. , 56,	Experimental Group, Scaling and root planing with Chlorhexidine mouthrinse and Systemic Antibiotics, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally. Participants with severe periodontitis ≥ 6mm were placed on systemic antibiotics, in form of oral amoxicillin 500 mg and metronidazole 400 mg eight hourly for five days. , 56,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	14/07/2026	The change is in response to the review comments to differentiate the intervention names for all the groups	Experimental Group, Scaling and root planing with Chlorhexidine mouthrinse and Systemic Antibiotics, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally. Participants with severe periodontitis ≥ 6mm were placed on systemic antibiotics, in form of oral amoxicillin 500 mg and metronidazole 400 mg eight hourly for five days. , 56,	Experimental Group, Systemic Antibitoics and Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally. Participants with severe periodontitis ≥ 6mm were placed on systemic antibiotics, in form of oral amoxicillin 500 mg and metronidazole 400 mg eight hourly for five days. , 56,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	27/05/2026	This is in response to Review Comments to review the intervention names for all the groups, and remove "conditions or disease".	Control Group, Normoglycemic, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 16, Active-Treatment of Control Group	Control Group, Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 16, Historical
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	27/05/2026	This is in response to Review Comments to review the intervention names for all the groups, and remove "conditions or disease".	Control Group, Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 16, Historical	Control Group, Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 16, Active-Treatment of Control Group
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	22/07/2026	This is in response to the reviewer's request to differentiate the intervention groups. Hence the control group has an intervention name and description different from the experimental group.	Control Group, Scaling and root planing with Chlorhexidine mouthrinse, Adjunctive irrigation of periodontal sites with pocket depths ≥ 4mm with 0.2% Chlorhexidine mouth rinse. , While undergoing full mouth disinfection., Full mouth disinfection in form of scaling and root planing of periodontal sites with probing depths ≥ 4mm using 0.2% Chlorhexidine mouthrinse as irrigating solution subgingivally., 16, Active-Treatment of Control Group	Control Group, Scaling and root planing with Chlorhexidine mouthrinse and No Systemic antibiotics, No systemic antibiotics , Not applicable, Only full mouth disinfection in form of scaling and root planing of periodontal pockets ≥ 4mm, and subgingival irrigation using 0.2% Chlorhexidine mouthrinse., 56, Active-Treatment of Control Group
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Body Mass Index/ BMI, At baseline and three months post-intervention	Secondary Outcome, Body Mass Index/ BMI, At baseline and three months post-intervention.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Primary Outcome, Mouthrinse active matrix metalloproteinase - 8 / aMMP-8 level , three months	Primary Outcome, Mouthrinse active matrix metalloproteinase - 8 / aMMP-8 level , At baseline and three months after intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Primary Outcome, Mouthrinse active matrix metalloproteinase - 8 / aMMP-8 level , At baseline and three months after intervention	Primary Outcome, Mouthrinse active matrix metalloproteinase - 8 / aMMP-8 level , At baseline and three months postintervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Primary Outcome, Mouthrinse active matrix metalloproteinase - 8 / aMMP-8 level , At baseline and three months postintervention	Primary Outcome, Mouthrinse active matrix metalloproteinase - 8 / aMMP-8 level , At baseline and three months post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Periodontal clinical parameters scores - probing depth, clinical attachment loss, plaque index, oral hygiene index score, bleeding on probing percentage, gingival index, periodontal inflamed surface area, three months	Secondary Outcome, Periodontal clinical parameters scores - probing depth, clinical attachment loss, plaque index, oral hygiene index score, bleeding on probing percentage, gingival index, periodontal inflamed surface area, At baseline and three months after intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Periodontal clinical parameters scores - probing depth, clinical attachment loss, plaque index, oral hygiene index score, bleeding on probing percentage, gingival index, periodontal inflamed surface area, At baseline and three months after intervention	Secondary Outcome, Periodontal clinical parameters scores - probing depth, clinical attachment loss, plaque index, oral hygiene index score, bleeding on probing percentage, gingival index, periodontal inflamed surface area, At baseline and three months postintervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Periodontal clinical parameters scores - probing depth, clinical attachment loss, plaque index, oral hygiene index score, bleeding on probing percentage, gingival index, periodontal inflamed surface area, At baseline and three months postintervention	Secondary Outcome, Periodontal clinical parameters scores - probing depth, clinical attachment loss, plaque index, oral hygiene index score, bleeding on probing percentage, gingival index, periodontal inflamed surface area, At baseline and three months post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Glycated hemoglobin level - HbA1c, three months	Secondary Outcome, Glycated hemoglobin level - HbA1c, At baseline and three months after intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Glycated hemoglobin level - HbA1c, At baseline and three months after intervention	Secondary Outcome, Glycated hemoglobin level - HbA1c, At baseline and three months postintervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Glycated hemoglobin level - HbA1c, At baseline and three months postintervention	Secondary Outcome, Glycated hemoglobin level - HbA1c, At baseline and three months post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Serum high sensitivity C-reactive protein level - hsCRP, three months	Secondary Outcome, Serum high sensitivity C-reactive protein level - hsCRP, At baseline and three months after intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Serum high sensitivity C-reactive protein level - hsCRP, At baseline and three months after intervention	Secondary Outcome, Serum high sensitivity C-reactive protein level - hsCRP, At baseline and three months post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Body Mass Index/ BMI, three months	Secondary Outcome, Body Mass Index/ BMI, At baseline and three months after intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	18/05/2026	The change is for clarity of the outcome measured, in response to the reviewer's comments.	Secondary Outcome, Body Mass Index/ BMI, At baseline and three months after intervention	Secondary Outcome, Body Mass Index/ BMI, At baseline and three months post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	18/05/2026	This is to align the email address and tel no. of the ethics committee with that on the approval letter.	TRUE, College of Medicine University of Lagos Health Research Ethics Committee, 2nd Floor Biomedical Engineering Block College of Medicine University of Lagos, Idi-Araba, Lagos, Lagos, 100254, Nigeria, , 06 Jan 2022, +2348055451018, kumeiz09@gmail.com, 41171_38409_4737.pdf	TRUE, College of Medicine University of Lagos Health Research Ethics Committee, 2nd Floor Biomedical Engineering Block College of Medicine University of Lagos, Idi-Araba, Lagos, Lagos, 100254, Nigeria, , 06 Jan 2022, +2348028642463, hrec@cmul.edu.ng, 41171_38409_4737.pdf

Pan African Clinical Trials Registry