About this trial
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:
1. Clinical assessment. 2. 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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Insulin
- Hyaluronic acid gel
- mechanical debridement
Treatment groups
Sponsors and collaborators
Doaa Atta Aid
Lead sponsor
Faculty of Dental Medicine for Girls
Sponsor institution
Al-Azhar University
Collaborator