Comparison of effects of non-surgical periodontal therapy with and without chemical plaque biofilm control on status of periodontitis and glycemic control in type 2 diabetic and non-diabetic patients – a randomized controlled trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- HbA1c (Glycosylated haemoglobin) levels
Study Overview
Brief Summary
Background: Despite several investigations, evidence is still controversial regarding the effect of non-surgical periodontal treatment on diabetes mellitus (DM) and the changes in periodontal disease status after such treatment.
Aims: This study will evaluate and compare the changes in glycosylated haemoglobin (HbA1c) levels and periodontal scores in a cohort of type2 DM patients with periodontitis after non-surgical periodontal treatment that will include regular mechanical plaque biofilm control instructions combined with professionally performed scaling and root planing (SRP)versus scores in same cohort treated with non-surgical periodontal treatment that will include SRP along with mechanical and chemical plaque biofilm control; as well as to evaluate and compare changes in similar levels and scores after the two non-surgical periodontal treatments are performed in an age and sex matched cohort of non-diabetic patients with periodontitis; over a follow-up period of 6 months.
Materials and methods: A cohort of 40 participants who are presenting with type 2 DM and stage I or stage II periodontitis will be selected from the out-patients visiting the department and an informed consent will be administered. The participants will be randomized into two groups, in one group mechanical plaque biofilm control instructions combined with professionally performed scaling and root planing (SRP), will be performed and in the other group additionally chemical plaque biofilm control consisting of daily mouthwash with 0.12% chlorhexidine gluconate will be prescribed. In an age and sex matched cohort consisting of 40 non-diabetics with stage I or stage II periodontitis, identical procedure will be performed. Periodontal disease scores of plaque index, gingival index, bleeding on probing, pocket probing depth and clinical attachment levels will be measured at baseline, and at 3- and 6-months after treatment. HbA1c levels will be recorded at baseline and at 6 months after treatment.
Data Analysis. The changes in HbA1c levels and periodontal scores will be compared in each group in both cohorts. The data will be analyses statistically with standard analysis of variance at a level of significance of p≤0.05
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy Indian patient other than presence of dysglycaemia (if any).
- •Presence of stage I or stage II severity of Periodontitis (case definition of Periodontitis is given below-with).
- •Ready to come for 6-month recall.
Exclusion Criteria
- •Lack of motivation and/or compliance.
- •Moderate/heavy smoking.
- •More than 2 missing teeth other than third molars in any one quadrant.
- •Any medical condition that contraindicates periodontal therapy.
- •Undergoing orthodontic treatment.
- •Pregnancy, or under treatment with estrogen/progesterone substitutes or taking oral contraceptives.
- •Periodontal surgery in the last six months.
- •Taken antibiotics course or steroid course in last 2 months.
Outcomes
Primary Outcomes
HbA1c (Glycosylated haemoglobin) levels
Time Frame: t0 - basleine; before scaling and polishing | t6 - 6 months after scaling and polishing
Secondary Outcomes
- Plaque Index, as described by Silness and Löe (1964)(t0 - basleine; before scaling and polishing)
- Gingival index as described by Löe and Silness (1963)(t0 - basleine; before scaling and polishing)
- Periodontal Bleeding on probing as described by Lang et al., (1990)(t0 - basleine; before scaling and polishing)
- Periodontal Pocket Probing Depth(t0 - basleine; before scaling and polishing)
- Periodontal Clinical Attachment Level(t0 - basleine; before scaling and polishing)
Investigators
Dr Shivam Agarwal
Uttaranchal Dental and Medical Research Institute