Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insulin, Hyaluronic acid gel, mechanical debridement.
- Who it may be relevant to
- Registry conditions: Treatment of Stage III Periodontitis, Local Application of Insulin in Pockets. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical Trial
Overview
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).
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.
Interventions
- Drug Insulin
subgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin - Drug Hyaluronic acid gel
Topical application of hyaluronic acid gel into periodontal pockets after scaling and root planing. - Procedure mechanical debridement
sub gingival scaling and root planning of periodontal pockets
Primary outcome measures
- Periodontal pocket depth (PPD) [Time frame: 3-6 months]
- Clinical attachment loss (CAL) [Time frame: 3-6 months]
Secondary outcome measures (3)
- Change in gingival index (GI) [Time frame: 3-6 months follow up]
- Change in bleeding on probing index (BOP) [Time frame: 3-6 months follow up]
- Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket [Time frame: 3-6 months follow up]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Alazhar university — Cairo
- Faculty of Dental Medicine for Girls, Al-Azhar University — Cairo
Identifiers
NCT: NCT07746206 · OMPDR-105-2K