Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206830062994 Date of Approval: 01/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARATIVE EFFECTS OF ADJUNCTIVE PROBIOTICS VERSUS ANTIBIOTICS ON THE EFFICACY OF SUBGINGIVAL SCALING AND ROOT PLANING AMONG ADULTS WITH LOCALIZED PERIODONTITIS IN LAGOS STATE UNIVERSITY TEACHING HOSPITAL
Official scientific title COMPARATIVE EFFECTS OF ADJUNCTIVE PROBIOTICS VERSUS ANTIBIOTICS ON THE EFFICACY OF SUBGINGIVAL SCALING AND ROOT PLANING AMONG ADULTS WITH LOCALIZED PERIODONTITIS IN LAGOS STATE UNIVERSITY TEACHING HOSPITAL
Brief summary describing the background and objectives of the trial Periodontitis is multifactorial in etiology, involving an interplay between microbial, environmental and host factors. The pathogenic microorganisms responsible for periodontitis are usually anaerobes which are highly susceptible to antibiotic therapy. The current treatment approaches to periodontitis, which include subgingival scaling and root planing, are aimed at reducing the pathogenic microorganisms. The administration of favourable bacteria called probiotics has emerged as a promising concept in the prevention and treatment of periodontitis. The objectives are: To determine the effect of probiotics as adjunct to subgingival scaling and root planing To determine the effect of antibiotics as adjunct to subgingival scaling and root planing To compare the effect of probiotics as adjunct to subgingival scaling and root planing with that of subgingival scaling and root planing alone To compare the effect of antibiotics as adjunct to subgingival scaling and root planing with that of subgingival scaling and root planing alone
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial To test the efficacy of probiotics as adjunct to subgingival scaling and root planing in the treatment of periodontitis
Anticipated trial start date 13/06/2022
Actual trial start date
Anticipated date of last follow up 13/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
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 Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Subgingival scaling and root planing plus hot saline mouthbath One visit subgingival scaling and root planing plus 6 times daily use of hot saline mouthbath 14 days Subgingival scaling and root planing will be done with sterilized curettes and normal saline on a dental chair 18 Active-Treatment of Control Group
Experimental Group Subgingival scaling and root planing plus Probiotics One visit subgingival scaling and root planing plus twice daily use of probiotic lozenges 14 days Subgingival scaling and root planing will be done with sterilized curettes on a dental chair immediately after which probiotics will be administered 18
Experimental Group Subgingival scaling and root planing plus Antibiotics One visit subgingival scaling and root planing plus antibiotics twice daily and hot saline mouth bath 6 times daily 14 days Subgingival scaling and root planing will be done using sterilized curettes immediately after which antibiotics will be used orally 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Periodontal pockets of 4 to 5mm affecting at least 4 teeth Clinical attachment loss of 4 to 6mm affecting at least 4 teeth Patients with no underlying systemic diseases between 18 to 59 years of age Chronic gingivitis patients presenting with gingival bleeding on probing Less than 20 teeth Had subgingival scaling and root planing less than or equal to 6 months prior to the period of recruitment Systemic diseases such as rheumatic heart disease, prosthetic heart valves, diabetes mellitus, hypertension, autoimmune diseases, osteoporosis Patients who have used medications with effect on periodontium such as phenytoin, nifedipine or oral contraceptives within 3 months of the study Currently using formulated mouth rinse agents which can disturb the microbial environment in the oral cavity Pregnant/breast feeding patients Former and current smokers Patients on probiotic supplements within 3 months prior to study and those allergic to probiotics or its lactate contents Mentally/physically handicapped individuals who cannot adhere to oral hygiene instructions Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 59 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 28/01/2022 LAGOS STATE UNIVERSITY TEACHING HOSPITAL RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1-5 OBA AKINJOBI ROAD, IKEJA LAGOS IKEJA 21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical attachment gain which is the decrease in sum of probing pocket depth and gingival recession which will be measured with the University of North Carolina-15 periodontal probe Oral hygiene which will be measured using Community Periodontal Index of Treatment Need-Clinical periodontal probe Baseline, 1 month, 3 months
Secondary Outcome Plaque Index which will be measured using the Community Periodontal Index of Treatment Needs-Clinical periodontal probe Gingival Index which will be measured using the University of North Carolina-15 periodontalprobe probe Baseline, 1 month, 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-5 OBA AKINJOBI ROAD IKEJA 21005 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR. NDUGBU CHUKWUEMEKA UZODINMA DEPARTMENT OF PREVENTIVE DENTISTRY LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-5 OBA AKINJOBI ROAD IKEJA 21005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR. NDUGBU CHUKWUEMEKA UZODINMA DEPARTMENT OF PREVENTIVE DENTISTRY 1-5 OBA AKINJOBI ROAD IKEJA 21005 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHUKWUEMEKA NDUGBU emekandugbu@gmail.com +2348061227078 DEPARTMENT OF PREVENTIVE DENTISTRY LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-5 OBA AKINJOBI ROAD
City Postal code Country Position/Affiliation
IKEJA 21005 Nigeria SENIOR RESIDENT
Role Name Email Phone Street address
Scientific Enquiries OLUFEMI OLAGUNDOYE framalt@yahoo.com +234808130005531 DEPARTMENT OF PREVENTIVE DENTISTRY LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-5 OBA AKINJOBI ROAD
City Postal code Country Position/Affiliation
IKEJA 21005 Nigeria CONSULTANT
Role Name Email Phone Street address
Scientific Enquiries OLANREWAJU OPEODU opeodulanre@yahoo.com +2349078285731 DEPARTMENT OF PERIODONTOLOGY AND COMMUNITY DENTISTRY UNIVERSITY COLLEGE HOSPITAL
City Postal code Country Position/Affiliation
IBADAN Nigeria CONSULTANT
Role Name Email Phone Street address
Public Enquiries MODUPEORE SORUNKE modupeore.sorunke@lasucom.edu.ng +2348033152418 DEPARTMENT OF PREVENTIVE DENTISTRY LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-5 OBA AKINJOBI ROAD
City Postal code Country Position/Affiliation
IKEJA 21005 Nigeria HEAD OF DEPARTMENT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial after deidentification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan IPD/additional documents will be available for sharing 18 months from now which will be 12 months after completion of study Controlled request access Statistical analysis plan, informed consent and clinical study report will be permitted Data will be available beginning 9 months and ending 36 months following article publication Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose Data will be released to achieve aims in the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information