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

NCT ID: NCT06997731

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2025-02-01

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.

Conditions

Periodontitis and Diabetes; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scaling and Root Planing with 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.

Group Type: PLACEBO_COMPARATOR

Non -surgical treatment and oral hygiene instruction

Intervention Type: 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.

local application of placebo gel

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Non -surgical treatment and oral hygiene instruction

Intervention Type: 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.

Application of minocycline and hyaluronic acid gel.

Intervention Type: DRUG

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

minocycline and Gengigel® gel without scaling and root planing

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

Group Type: EXPERIMENTAL

Application of minocycline and hyaluronic acid gel.

Intervention Type: DRUG

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

Interventions

Non -surgical treatment and oral hygiene instruction

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.

Intervention Type: PROCEDURE

Application of minocycline and hyaluronic acid gel.

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

Intervention Type: DRUG

local application of placebo gel

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Enas Elgendy

Professor of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Enas Elgendy

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

Kafrelsheikh

Identifier Type: -

Identifier Source: org_study_id