Comparative Evaluation Of Two Different Maintaenance Protocols In Type-2 Diabetic Patients Undergoing Non- Surgical Periodontal Therapy

Phase 3

Active, not recruiting

Conditions: Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2021/08/035988

Lead Sponsor: NA

Brief Summary: Diabetes mellitus and periodontal diseases are amongst the most prevalent disorders in the human population.For many years, attempts have been made to relate the two disorders.After years of research, it has been established that periodontal disease and diabetes mellitus share a two way relationship. Diabetes mellitus has many complications systemically and one of its complications is periodontitis. Conversely, periodontitis is more than a localized oral infection and may cause changes in the systemic physiology. Type 1 diabetes is presumed to originate from autoimmune process and is controlled by insulin administration only. Also, type 1 diabetes accounts for only 5-10% of all cases of diabetes. Type 1 diabetics, in general are too young to develop moderate or severe forms of periodontitis. Thus, our focus is usually directed towards association of periodontitis with type 2 diabetes. There is evidence to support that controlling periodontal infection plays an important role in the overall management of type 2 diabetics. An effective periodontal treatment within diabetics may inhibit the production of pro inflammatory mediators.Thus, periodontal treatment and follow up might be considered in the treatment plan of diabetic patients especially in poorly controlled glycemic level patients. Although, a major milestone has been reached, we need to have a complete understanding on the management and care of the periodontal disease in diabetic patients.It has also been suggested that use of water irrigation as an adjunctive therapy along with non surgical periodontal treatment may have an adjunctive value in establishing a more healthy periodontal environment. There is paucity of literature related to the use of oral sub gingival home irrigation as an adjunct to non- surgical periodontal therapy in type 2 diabetics.Hence, the purpose of our study is aimed at treating type 2 diabetic patients with generalized chronic periodontitis by non- surgical periodontal therapy along with the adjunctive use of sub gingival water irrigation system as homecare maintenance for a period of 3 months and compare the value of clinical and diabetic parameters in order to evaluate the efficacy of our treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 40

Inclusion Criteria

INCLUSION CRITERIA:7,20,21 Type 2 diabetic patients (HbA1c < 7%) with generalized chronic periodontitis according to classification by AAP by Armitage.
Subjects who are on oral hypo-glycemic agents or insulin injections and prescribed diet in combination or separately.
They should be diabetic for >1 year and on the same type and dose of diabetic medication for past 6 months.
Patients who are in good physical condition and do not have any major illness or serious medical condition or transmissible disease.
Patients willing to give informed consent.

Exclusion Criteria

EXCLUSION CRITERIA:7,8,19,22,23 History of systemic antibiotic usage over the past 4 months Pregnant or lactating women Non-surgical periodontal treatment within past 6 months Use of immunosuppressive medications Subjects with intake of supplemental ascorbic acid Subjects with history of prolonged drug use that interfere with coagulation system, e.g. Coumarin derivatives History of severe cardiovascular, hematological, renal, hepatic and immunological disorders Patients who are smokers and alcoholics Patient not willing to give informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gingival index (GI)	BASELINE \| 1 MONTH AFTER BASELINE \| 2 MONTHS AFTER BASELINE \| 4 MONTHS AFTER BASELINE
Plaque index (PI)	BASELINE \| 1 MONTH AFTER BASELINE \| 2 MONTHS AFTER BASELINE \| 4 MONTHS AFTER BASELINE
Oral hygiene index (OHI-S)	BASELINE \| 1 MONTH AFTER BASELINE \| 2 MONTHS AFTER BASELINE \| 4 MONTHS AFTER BASELINE
Gingival bleeding index (GBI)	BASELINE \| 1 MONTH AFTER BASELINE \| 2 MONTHS AFTER BASELINE \| 4 MONTHS AFTER BASELINE
Pocket depth(PD)	BASELINE \| 1 MONTH AFTER BASELINE \| 2 MONTHS AFTER BASELINE \| 4 MONTHS AFTER BASELINE
Clinical attachment loss (CAL)	BASELINE \| 1 MONTH AFTER BASELINE \| 2 MONTHS AFTER BASELINE \| 4 MONTHS AFTER BASELINE

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	HbA1c

Trial Locations

Locations (1): J.N.Kapoor D.A.V (C) Dental College, Yamunanagar 135001
🇮🇳
Yamunanagar, HARYANA, India
J.N.Kapoor D.A.V (C) Dental College, Yamunanagar 135001
🇮🇳Yamunanagar, HARYANA, India
Dr CV Sruthi Vyaasini
Principal investigator
9541924677
cvsruthivyaasini@gmail.com