A comparative evaluation of the effectiveness of scaling and root planing alone or with the adjunct therapy of laser curettage in chronic periodontitis patients diagnosed with type-2 diabetes mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- IMPROVEMENTS IN CLINICAL PARAMETERS VIZ PLAQUE INDEX, GINGIVAL INDEX, PROBING DEPTH AND CLINICAL ATTACHMENT LEVEL
Study Overview
Brief Summary
Periodontitis and diabetes mellitus have complex and unique bidirectional associations. The two-way relationship between the two chronic diseases is an intersection between environmental, microbiologic, genetic, and immunologic factors. Although periodontitis was understood as the sixth complication of diabetes mellitus, currently the two diseases are considered as “comorbid old friends.†in the same light, periodontal treatment reduces serum levels of inflammatory markers. A meta-analysis of clinical trials that investigated the effect of periodontal treatment on HbA1c levels found an HbA1c decrease of 0.29% at 3 months after periodontal treatment (Simpson et al. 2015). In parallel to HbA1c improvements, reductions in local periodontal inflammation, pocket depths, and low-grade systemic inflammation were observed. Non -surgical periodontal treatment resulted in a better glycemic status of type 2 diabetes patients and demonstrated the importance of oral health in their general health. Another meta-analysis indicated a mean treatment effect of -0.36% HbA1c (CI -0.54, -0.19) compared to no treatment after periodontal therapy (p < 0.0001) (Engrebetson, Kocher 2015). Diode Laser therapy benefits the periodontium directly by eliminating the pathogens and disinfecting the pockets and indirectly by reducing the hyper inflammatory status and improves the collagen formation and thus, healing will be accelerated of Diabetes Mellitus patients. DL treatment can provide improved clinical results when it is used as an adjunct to nonsurgical periodontal treatment in Chronic periodontitis patients with Diabetes Mellitus.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Medical history of Type 2 Diabetes Mellitus with HbA1c reading of more than 6.5% Patients with chronic periodontitis with vertical probing depth of ≥4 mm Patients is self motivated for good oral hygiene.
- •Patients who have not undergone any surgical periodontal therapy in last 6 months Patients who are ready to sign informed written consent and will be able to follow recall protocols.
Exclusion Criteria
- •Debilitating systemic or infectious diseases (HIV or hepatitis) or any diseases except diabetes mellitus that affect the periodontium.
- •Patients taking immunosuppressive drugs or corticosteroids which may compromise the treatment outcome.
- •Pregnant women or lactating mothers.
- •Failure to complete the informed consent.
- •Use of tobacco products either in smoking or smokeless tobacco habit Poor compliance or failure to maintain good oral hygiene.
Outcomes
Primary Outcomes
IMPROVEMENTS IN CLINICAL PARAMETERS VIZ PLAQUE INDEX, GINGIVAL INDEX, PROBING DEPTH AND CLINICAL ATTACHMENT LEVEL
Time Frame: 12 WEEKS OR 3 MONTHS
Secondary Outcomes
- REDUCTION IN HBA1C(12 WEEKS)