Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis

Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical 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).

Study Overview

• Status: Recruiting
• Conditions: Treatment of Stage III Periodontitis; Local Application of Insulin in Pockets
• Intervention / Treatment: Drug: Insulin; Drug: Hyaluronic acid gel; Procedure: mechanical debridement

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Alazhar University
    • Contact: Doaa Abdelrazik, BDS; Phone Number: 00201012430093 00201012430093; Email: duaaabdelrazik@gmail.com
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dental Medicine for Girls, Al-Azhar University
    • Contact: Doaa Abdelrazik, BDS; Phone Number: 00201012430093; Email: duaaabdelrazik@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: scaling and root planning and topical insulin for stage Ⅲ periodontitis patients; Participants receive scaling and root planing followed by topical application of insulin gel into periodontal pockets.	Drug: Insulin; subgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin
Experimental: scaling and root planning with topical application of hyaluronic acid gel; Participants receive scaling and root planing followed by topical application of hyaluronic acid gel into periodontal pockets.	Drug: Hyaluronic acid gel; Topical application of hyaluronic acid gel into periodontal pockets after scaling and root planing.
Active Comparator: Stage III periodontitis patients; patients have stage III periodontitis	Procedure: mechanical debridement; sub gingival scaling and root planning of periodontal pockets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gingival index (GI)	(GI) index measured at 4 sites per tooth (buccal, mesial, distal, and lingual).	3-6 months follow up
Change in bleeding on probing index (BOP)	(BOP) determined by the presence or absence of bleeding (with in15 sec.) after periodontal probing.	3-6 months follow up
Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket	Using the Bioassay Technology Laboratory IL-1β ELISA kit to determine levels of IL-1β in (GCF) using enzyme-linked immunosorbent assay (ELISA).	3-6 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index (PI)	PI describe by scores according to Loe H and Sillness J.	From 3 to 6 months

Collaborators and Investigators

• Sponsor: Doaa Atta Aid
• Collaborators: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2026
• Primary Completion (Actual): July 25, 2026
• Study Completion (Estimated): July 25, 2026

Study Registration Dates

• First Submitted: July 25, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Proinsulin; Insulin
• Other Study ID Numbers: OMPDR-105-2K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No