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.: PACTR202111744581541 Date of Approval: 08/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of periodontal therapy on glycaemic control in Nigerians with type 2 diabetes mellitus and moderate to severe periodontitis
Official scientific title Periodontal therapy and glycaemic control in Nigerians with type 2 Diabetes Mellitus: A pilot study:
Brief summary describing the background and objectives of the trial Periodontitis and diabetes mellitus are both pathologic conditions that could negatively interfere with each other through a bi-directional relationship. The association between the two conditions has been documented. Diabetes increases the risk of periodontitis. Also, periodontitis negatively affects glycaemic control and the progression of vascular complications. The beneficial effects of periodontal treatment in individuals with type 2 DM and its influence on their metabolic control are documented. The observations are however equivocal as evidenced by the findings of other studies.The prevalence of type 2 diabetes mellitus has been significantly increasing in sub-Saharan Africa and the estimated rates of undiagnosed disease in the region is particularly high. Nigeria has the highest of type 2 diabetes in Africa with high prevalence of periodontitis. In addition, it has been reported that Nigerian doctors appear to have a low awareness of the association between periodontitis and poor glycaemic control..This study therefore aimed to determine if non-surgical periodontal therapy will improve glycaemic control in individuals who have type 2 diabetes with moderate to severe periodontitis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) None
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/12/2016
Actual trial start date 22/12/2016
Anticipated date of last follow up 01/03/2018
Actual Last follow-up date 22/03/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 54
Recruitment status Completed
Publication URL Not yet
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Scaling and root planing with Oral hygiene instruction and motivation Scaling and root planing was done once. Oral hygiene instruction and motivation was given at least once for 3 months 3 months Scaling and root planing was performed once for the test group and reviewed after 3 months. Oral hygiene instruction and motivation was also given at least once for all participants. Their contacts were obtained so that reiteration could be done within the 3 months before the review 27
Control Group Oral hygiene instruction and motivation alone At least once to all participants in this group 3 months Patients were given instruction on how to clean their teeth and regularly remove plaque ( tooth deposit) from the tooth surface 27 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants who have been diagnosed and are being managed for type 2 DM at the endocrinology clinic for at least 1 year Participants who have been on oral hypoglycaemic agents with or without insulin therapy for at least 1 year Participants who have moderate to severe chronic periodontitis as evidenced by ≥2 interproximal sites with pocket depth ≥5mm (not on same tooth) according to Centres for Disease Control and Prevention in partnership with the American Academy of Periodontology, 2005; modified by Eke and Page, 2012.33 Participants must have minimum of 20 teeth Body Mass Index <30 Participants who have neither smoked cigarette nor quit cigarette smoking < 5 years Current smokers Pregnancy Known cases of immunosupression (Immunosuppressive drugs, tuberculosis, malnutrition, Acquired Immuned Deficiency State, long-term steroid use) Participants who had undergone non-surgical periodontal therapy in the last six months Long term use of anti-inflammatory medications/antibiotics in the last six months. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 10/06/2016 ETHICS AND RESEARCH COMMITTEE OBAFEMI AWOLOWO TEACHING HOSPITALS COMPLEX
Ethics Committee Address
Street address City Postal code Country
Phase 1, Ilesha road, Ile Ife Ile Ife 220231 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glycaemic control as measured by the level of glycated haemoglobin was the primary outcome. Secondary outcomes are probing pocket depth and clinical attachment loss for the measurement of periodontal status Baseline and at 3 months
Secondary Outcome Periodontal status measured by clinical attachment loss and probing pocket depth Baseline and at 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Endocrinology unit and the Periodontology unit of Obafemi Awolowo University Teaching Hospitals Complex Ile Ife Osun State Nigeria Phase 1 ,Ilesha road, Ile-Ife Ile Ife 220231 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibukun Ojo N0 1, Adeojo street, Ile Ife Ile Ife 220231 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ojo Ibukun No 1 ,Adeojo street, Ile-Ife, osun State ,Nigeria Ile Ife 220231 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator IBUKUN OJO profojo2007@gmail.com +2348060893716 No 1, Adeojo Street, Ile-Ife
City Postal code Country Position/Affiliation
Ile Ife 220231 Nigeria Consultant Periodontologist
Role Name Email Phone Street address
Public Enquiries Solomon Nwhator periodontogist2010@gmail.com +2349021074527 Opa, Ilesha road, Ile Ife
City Postal code Country Position/Affiliation
Ile Ife 220231 Nigeria Senior Lecturer and Consultant Periodontologist Obafemi Awolowo univerity Ile Ife
Role Name Email Phone Street address
Scientific Enquiries Babatope Kolawole bakolawole@gmail.com +2348033804884 Aladanla, Ilesha road ,ile Ife
City Postal code Country Position/Affiliation
Ile Ife 220231 Nigeria Professor and Consultant endocrinologist Obafemi awolowo University ile ife
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article would be made available after de-identification (texts, table, figure) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning from 9 months and ending 5 years after the publication of the article. A link would be made available in order to access the data after the article has been published
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://pdf.ac/mx6i6 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