NCT06997731

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

Local Delivery of Hyaluronan and Minocycline as an Adjunct to Scaling and Root Planing in the Treatment of Stage 2 Grade B Periodontitis in Diabetic Patients: A Randomize Control Clinical Trial With Clinical and Microbiological Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	Application of minocycline and hyaluronic acid gel.	application of minocycline and Gengigel® topical gel twice weekly for 3-week 1cc for each.
DRUG	local application of placebo gel	The placebo gel will be applied in the periodontal pocket twice weekly for 3-week 1cc for each.

Timeline

• Start date: 2023-05-20
• Primary completion: 2025-01-01
• Completion: 2025-02-01
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: Egypt