Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis

NCT07746206 | Recruiting Early Phase 1 DMC

• 1 other identifier: OMPDR-105-2K
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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:

1. 1.Clinical assessment.
2. 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.

Conditions

Treatment of Stage III Periodontitis; Local Application of Insulin in Pockets

Outcome Measures

Primary Outcomes (2)

• Periodontal pocket depth (PPD)

  (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).

  3-6 months

• Clinical attachment loss (CAL)

  (CAL) measured in(mm)from the cemento-enamel junction (CEJ) to the base of the pocket at the same previous six sites per tooth.

  3-6 months

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Plaque index (PI)

  From 3 to 6 months

Study Arms (3)

scaling and root planning and topical insulin for stage Ⅲ periodontitis patients

ACTIVE 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 gel

EXPERIMENTAL

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

Drug: Hyaluronic acid gel

Stage III periodontitis patients

ACTIVE COMPARATOR

patients have stage III periodontitis

Procedure: mechanical debridement

Interventions

Insulin DRUG

subgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin

scaling and root planning and topical insulin for stage Ⅲ periodontitis patients

Hyaluronic acid gel DRUG

Topical application of hyaluronic acid gel into periodontal pockets after scaling and root planing.

scaling and root planning with topical application of hyaluronic acid gel

mechanical debridement PROCEDURE

sub gingival scaling and root planning of periodontal pockets

Stage III periodontitis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Doaa Atta Aid: lead
• Al-Azhar University: collaborator

Study Sites (2)

Alazhar university

Cairo, Egypt

RECRUITING

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 4, 2026
• Study Start: July 24, 2026
• Primary Completion: July 25, 2026
• Study Completion: July 25, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (2)