Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Periodontal pocket depth (PPD)
Study Overview
Brief Summary
The present study will be performed on fourty-five patients suffering from periodontitis according to the criteria of American academy of periodontology to evaluate clinically effect of topical application of insulin versus hyaluronic acid as an adjunct to non surgical periodontal therapy in stage Ⅲ periodontitis patients.
This will be done by:
- Clinical assessment.
- Biochemical analysis. - Dose the topical application of insulin or hyaluronic acid as an adjunct to non-surgical periodontal therapy improves periodontal condition in stage Ⅲ periodontitis patients? PICO P (Population): patients with stage Ⅲ periodontitis. I (Intervention): non surgical periodontal therapy (SRP) with topical application using insulin or hyaluronic acid in periodontal pockets.
C (Comparison): topical application of insulin versus hyaluronic acid and SRP alone in periodontal pocket.
O (Outcome): primary outcome: change in periodontal pocket depth (PPD) or clinical attachment loss (CAL). Secondary outcome: change in gingival index (GI) or bleeding on probing index (BOP) and levels of IL-1β in GCF of treated pocket.
Study type: Randomized controlled trials (RCTs).
Detailed Description
The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program.
The randomization of patients will form the following 3 groups:
Group (Ⅰ): control group including (15) stage Ⅲ periodontitis patients who will receive scaling and root planning (SRP) alone.
Group (Ⅱ): including (15) stage Ⅲ periodontitis patients who will receive topical application of insulin adjunct to SRP.
Group (Ⅲ): including (15) stage Ⅲ periodontitis patients who will receive topical application of hyaluronic acid adjunct to SRP.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All selected patients are free from systemic illness as evaluated according to dental modification of the Cornell medical index.
- •Should be diagnosed as having periodontitis.
- •Not received any type of periodontal treatment in the past 6 months prior to examination.
- •Should be cooperative, motivated, and willing to follow our treatment protocol and follow up visits.
- •Not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
Exclusion Criteria
- •Antibiotic therapy in the preceding 6 months or during study participation.
- •History of insulin dependent diabetes and thyroid disease.
- •Pregnancy, smoking, chronic diseases such as diabetes mellitus or rheumatoid arthritis, and allergy to ingredients in the drug.
- •Poor oral hygiene compliance or inability to adhere to the clinical protocol.
Outcomes
Primary Outcomes
Periodontal pocket depth (PPD)
Time Frame: 3-6 months
(PD) measured in (mm) from free gingival margin to the base of the pocket at six sites per tooth (mesiobuccal and mesiolingual, distobuccal and distolingual, and mid-buccal and mid-lingual regions).
Clinical attachment loss (CAL)
Time Frame: 3-6 months
(CAL) measured in(mm)from the cemento-enamel junction (CEJ) to the base of the pocket at the same previous six sites per tooth.
Secondary Outcomes
- Change in gingival index (GI)(3-6 months follow up)
- Change in bleeding on probing index (BOP)(3-6 months follow up)
- Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket(3-6 months follow up)
Investigators
Doaa Atta Aid
Doctor
Faculty of Dental Medicine for Girls