Clinical Efficacy of Local Delivery of Minocycline and Hyaluronan Gel to Treat Periodontitis in Diabetic Patients

NCT06997731 | Completed Phase 1

• 1 other identifier: Kafrelsheikh
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the local delivery of minocycline gel 2% and 0.2% hyaluronan gel to treat periodontitis in diabetic patients as adjunctive to subgingival instrumentation. The main question it aims to answer is: Does local use of minocycline gel and hyaluronan gel as an adjunct to SRP have resulted in significant additional improvement in the clinical conditions of stage II grade B periodontitis patients when compared with SRP alone?

Conditions

Periodontitis and Diabetes; Periodontitis

Keywords

minocycline gel; hyaluronan gel; periodontitis; Diabetes mellitus; microbiology; scaling and root palning

Outcome Measures

Primary Outcomes (3)

• Probing pocket depth (PPD)

  Probing pocket depth will be recorded at baseline and after 3 months post treatment from the gingival margines to the base of the pocket.

• Clinical attachment loss (CAL)

  Clinical attachment level will be recorded at baseline and 3 month post treatment.

• Microbiological assessment

  Porphyromonas gingivalis, Prevotella intermedia will be counted in subgingival plaque samples at baseline and after 3 months post-treatment

Secondary Outcomes (2)

• Plaque Index (PI)

  plaque index will be measured at baseline and 3 months after treatment.

• Gingival index (GI)

  Gingival index will be recorded at baseline and after 3 months post treatment.

Study Arms (3)

Scaling and Root Planing with placebo gel

PLACEBO COMPARATOR

Twenty sites received oral hygiene instruction and scaling\& root planning with placebo gel. * Full mouth scaling and root planning were performed in a single visit using hand instruments (scaler and universal curette). This was followed by application of a placebo gel to each studied site. * Oral hygiene was performed by twice daily brushing for 2 minutes.

Procedure: Non -surgical treatment and oral hygiene instruction; Drug: local application of placebo gel

Scaling& root planning followed by placement of local minocycline and Gengigel® gel

EXPERIMENTAL

Ten patients were treated with scaling\& root planning followed by placement of local minocycline and Gengigel® gel twice weekly for 3-week 1cc for each pocket.

Procedure: Non -surgical treatment and oral hygiene instruction; Drug: Application of minocycline and hyaluronic acid gel.

minocycline and Gengigel® gel without scaling and root planing

EXPERIMENTAL

ten patients were treated with minocycline and Gengigel® topical twice weekly for 3 week 1cc for each pocket without scaling \&root planning.

Drug: Application of minocycline and hyaluronic acid gel.

Interventions

Non -surgical treatment and oral hygiene instruction PROCEDURE

Scaling and root planing which involves mechanical removal of sup-gingival calculus and necrotic cementum. Tis will be associated with oral hygiene instruction in the form of twice daily brushing for 2 minutes.

Scaling and Root Planing with placebo gel; Scaling& root planning followed by placement of local minocycline and Gengigel® gel

Application of minocycline and hyaluronic acid gel. DRUG

application of minocycline and Gengigel® topical gel twice weekly for 3-week 1cc for each.

Scaling& root planning followed by placement of local minocycline and Gengigel® gel; minocycline and Gengigel® gel without scaling and root planing

local application of placebo gel DRUG

The placebo gel will be applied in the periodontal pocket twice weekly for 3-week 1cc for each.

Scaling and Root Planing with placebo gel

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with stage II, grade B periodontitis (Attachment loss 3-4 mm and probing pocket depth ≤ 5mm) in both sides.
• Adult controlled diabetic patients (Glycosylated hemoglobin (HbA1C) in controlled diabetics ≤7%)
• Patients who can maintain good oral hygiene

You may not qualify if:

• History of systemic diseases other than type II diabetes
• Smoking
• Pregnant or lactating women
• Previous treatment of periodontal diseases in the last six months (People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 6 month).
• People who use mouth washes regularly ·
• Participation in other clinical trials.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Enas Elgendy

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of oral medicine and periodontology

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 30, 2025
• Study Start: May 20, 2023
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)