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

Phase 1

Completed

• Conditions: Periodontitis and Diabetes; Periodontitis
• Interventions: Procedure: Non -surgical treatment and oral hygiene instruction; Drug: Application of minocycline and hyaluronic acid gel.; Drug: local application of placebo gel

• Registration Number: NCT06997731
• Lead Sponsor: Kafrelsheikh University

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?

Detailed Description

The aim of the present study was to evaluate the clinical and microbial efficacy of local delivery of minocycline gel 2% and 0.2% hyaluronan gel (Gengigel) as an adjunctive therapy to SRP compared with SRP alone in diabetes mellitus with periodontitis patients. A total of twenty controlled diabetic patients with moderate chronic periodontitis were included in the present study. The selected patients were divided into two groups (group I and group II) and every group was divided according to the split-mouth design into applied and control side. All patients were subjected to conventional periodontal therapy (SRP) except applied side of group II. Moreover, the applied side of each group was subjected to sub gingival delivery of minocycline gel and hyaluronan gel (Gengigel) and control side was subjected to SRP, the patients followed up for three weeks. Clinical parameters used in this study included plaque index (PI), gingival index (GI), Bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL). These parameters were measured before starting the treatment and after 3 months post treatment regimen. Sub-gingival plaque samples were taken before starting the treatment and after 1 month of treatment using sterile curette and delivered in a sterile tube containing a suitable transport media and analyzed for isolation of P. intermedia and P. gingivalis. The clinical results of both groups showed statistically significant improvement for both applied and control side which higher in applied side of group I for all clinical parameters and results of microbial evaluation showed that P. intermedia and P. gingivalis count decreased significantly after treatment in both groups especially in applied side of group I. Scaling and root planning (SRP) was effective in improving clinical and microbiological parameters in controlled diabetic patients suffering from stage II grade B periodontitis. Local use of minocycline gel and hyaluronan gel (Gengigel) as an adjunct to SRP has resulted in significant additional improvement in the clinical conditions of stage II grade B periodontitis patients when compared with SRP alone, Minocycline and hyaluronan gel (Gengigel) application results in sufficient reduction in bacterial challenge especially when combined with SRP.

Study Timeline

• Study Start: 2023-05-20
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and Root Planing with placebo gel	Non -surgical treatment and oral hygiene instruction	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.
minocycline and Gengigel® gel without scaling and root planing	Application of minocycline and hyaluronic acid gel.	ten patients were treated with minocycline and Gengigel® topical twice weekly for 3 week 1cc for each pocket without scaling \&root planning.
Scaling and Root Planing with placebo gel	local application of placebo gel	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.
Scaling& root planning followed by placement of local minocycline and Gengigel® gel	Non -surgical treatment and oral hygiene instruction	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.
Scaling& root planning followed by placement of local minocycline and Gengigel® gel	Application of minocycline and hyaluronic acid gel.	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.

Primary Outcome Measures

Name	Time	Method
Microbiological assessment	Porphyromonas gingivalis, Prevotella intermedia will be counted in subgingival plaque samples at baseline and after 3 months post-treatment
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Enas Elgendy; 🇪🇬 Tanta, Al Gharbīyah, Egypt