Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis | NCT07746206

NCT07746206

Overview

NCT ID: NCT07746206
Lead Sponsor: Doaa Atta AidOTHER_GOV
Official Title: Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical Trial
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).

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Participant Group/Arms

scaling and root planning and topical insulin for stage Ⅲ periodontitis patientsActive Comparator

Participants receive scaling and root planing followed by topical application of insulin gel into periodontal pockets.

Drug: Insulin

scaling and root planning with topical application of hyaluronic acid gelExperimental

Participants receive scaling and root planing followed by topical application of hyaluronic acid gel into periodontal pockets.

Drug: Hyaluronic acid gel

Stage III periodontitis patientsActive Comparator

patients have stage III periodontitis

Procedure: mechanical debridement

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