understanding the effect periodontal treatment on type 2 diabetes mellitus subjects

Completed

Conditions: Chronic periodontitis,

Registration Number: CTRI/2021/06/033985

Lead Sponsor: Haldia Institute of dental sciences and research

Brief Summary: this will be a single centre,parallel arm , investigator masked clinical trial in type 2 diabetes mellitus patients with periodontitis .aim of the study is to evaluate role of periodontal treatment on gylcaemic control.clinical periodontal parameter ,salivary biomarker and HBA1c are the variables to measure the treatment outcomes.this will be 12 months follow up study .

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 180

Inclusion Criteria

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 â‰¤ 6.0% and FPG < 99 mg/dl.

Exclusion Criteria

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 control	at 3, 6 and 12 months after non surgical periodontal therapy.

Secondary Outcome Measures

Name	Time	Method
Oral health behaviour and Quality of life assessment	3,6 and 12 months

Trial Locations

Locations (1): Haldia Institute of dental sciences and research
🇮🇳
Medinipur, WEST BENGAL, India
Haldia Institute of dental sciences and research
🇮🇳Medinipur, WEST BENGAL, India
Swet Nisha
Principal investigator
9883916227
swetnisha1@gmail.com