understanding the effect periodontal treatment on type 2 diabetes mellitus subjects
- Conditions
- Health Condition 1: K053- Chronic periodontitis
- Registration Number
- CTRI/2021/06/033985
- Lead Sponsor
- Haldia Institute of dental sciences and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Subjects with Gingivitis : full mouth bleeding on probing less than 10% of sites.
Subjects with Periodontitis : Subjects with Periodontitis with interdental clinical attachment
loss detectable at >- 2 non adjacent teeth .Buccal or oral clinical attachment loss >-3 mm
with pocketing > 3mm is detectable at >-2 teeth.
Subjects with Periodontally Healthy (PH) : Subjects with PH will have no history of periodontitis, no sites with PD and CAL > 3 mm concurrently and no more than 10% of the sites with gingival bleeding and/or BoP.
Diabetic subjects :The diabetic subjects will require a diagnosis of DM confirmed by a physician, dating from at least 2 years prior to the study. In addition, all diabetic patients will be required to have a HbA1c > 6.5% and FPG > 99 mg/dl.
Non-diabetics: Non-diabetic subjects will have no history of DM, HbA1c = 6.0% and FPG < 99 mg/dl.
Pregnancy; breastfeeding; subgingival periodontal therapy during the previous 12 months; use of antibiotic, anti-inflammatory, and/or immunosuppressive therapies during the previous 6 months; regular use of mouthrinses containing antimicrobials; use of orthodontic
appliances; presence of other infectious, immunological, and/or inflammatory systemic conditions (e.g., immunological disorders, rheumatoid arthritis) and major complications of DM (i.e.,ulcers, gangrene, amputation, neuropathy, and nephropathy),smokers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in clinical periodontal status, salivary biomakers level and markers of diabetes controlTimepoint: at 3, 6 and 12 months after non surgical periodontal therapy.
- Secondary Outcome Measures
Name Time Method Oral health behaviour and Quality of life assessmentTimepoint: 3,6 and 12 months