NCT06255067

Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel

"Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel in Stage II or Stage III Periodontitis: A Randomized Controlled Clinical Trial With Biochemical Analysis"

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the efficacy of Noisome as carrier of minocycline hydrochloride gel to minocycline hydrochloride in Stage II or Stage III Periodontitis . The main questions it aims to answer are: * Is the Noisome carrier of minocycline hydrochloride has an effect in comparing to minocycline hydrochloride in Stage II or Stage III Periodontitis? * what is the release profile of of minocycline hydrochloride noisome gel and minocycline hydrochloride gel? Participants will be asked to maintain oral hygiene after application of treatment Researchers will compare the effect of noisome as a carrier of locally delivered minocycline hydrochloride gel to minocycline hydrochloride gel in stage II or stage III periodontitis patients as an adjunct to non-surgical periodontal treatment\] to see if Plaque Index (PI) , Gingival index,Clinical attachment level (CAL) \&Periodontal Pocket Depth decreased or not.

Detailed description

This study is designed to be a Randomized, Controlled, blinded, clinical trial; the eligible participants will be randomly allocated for one of the two comparative parallel-Groups; test and control group . The interventions will be prepared by the pharmacist and coded and the whole-time frame for the study will be 18 weeks. The intervention to all participants will be Non-surgical debridement the the test group will receive the Noisome minocycline hydrochloride \& control group will receive minocycline hydrochloride.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DRUG	Minocycline hydrochloride with noisome carrier	patient will receive Non-surgical debridement followed by injection of local delivery drug in the deepest pocket site, This will be done one day, three days, seven days and fourteen days
DRUG	Minocycline Hydrochloride only	patient will receive Non-surgical debridement followed by injection of local delivery drug in the deepest pocket site, This will be done one day, three days, seven days and fourteen days

Timeline

• Start date: 2024-02-25
• Primary completion: 2024-05-25
• Completion: 2024-06-30
• First posted: 2024-02-12
• Last updated: 2024-02-12

Locations

2 sites across 1 country: Egypt