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

Phase 2

Not yet recruiting

• Conditions: Periodontitis
• Interventions: Drug: Minocycline hydrochloride with noisome carrier; Drug: Minocycline Hydrochloride only

• Registration Number: NCT06255067
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study First Submitted: 2023-12-26
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Study Start: 2024-02-25
• Primary Completion: 2024-05-25
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
• Generalized Periodontitis (Stage II or stage III ) Patients; ( ≥ 3 mm CAL, PD 5-7 mm ) , premolar-molar area (test site) .
• Having more than 16 tooth excluding wisdom and test teeth that still had both mesial and distal neighboring teeth.
• Systemically free according to the modified Burkitt's health history questionnaire

Exclusion Criteria

• Non-surgical periodontal therapy within the previous 12 months, systemic or local use of antibiotics with the previous 3 months, medication with possible influence on the periodontium.
• Pregnancy or contraceptives usage.
• Breastfeeding.
• Known allergy to the ingredients of the treatment.
• Smokers.
• vulnerable group; prisoners & orphans .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minocycline hydrochloride with noisome as carrier	Minocycline hydrochloride with noisome carrier	Group I ( Minocycline hydrochloride with noisome carrier) 15 patients will receive the drug ( Minocycline hydrochloride with noisome carrier gel) at intervals 1,3,7\&14 days
Minocycline hydrochoride only	Minocycline Hydrochloride only	Group II (Minocycline hydrochloride only) 15 patients will receive the drug (Minocycline hydrochloride only gel) at intervals 1,3,7\&14 days

Primary Outcome Measures

Name	Time	Method
To measure clinical assessment Plaque Index (PI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)	measured at the baseline, before the application of drug& after 18 weeks	To measure the clinical parameter Plaque Index (PI) on score from zero to three; 0 = No plaque in gingival area.; 1. = A film of plaque adhering to the free gingival margin and adjacent area of tooth. The plaque may be recognized only by running a probe across the tooth surface.; 2. = Moderate accumulation of soft deposit within the gingival pocket and on the gingival pocket and on the gingival margin and/or adjacent tooth surface that can be seen by naked eye.; 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
To measure clinical assessment Gingival Index (GI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)	measured at the baseline, before the application of drug& after 18 weeks	To measure the clinical parameter gingival Index(GI) on score from zero to three; Gingival index (GI) 0 = Normal gingiva.; 1. = Mild inflammation, slight change in color, slight edema; no bleeding on probing.; 2. = Moderate inflammation, redness, edema, and glazing; bleeding on probing.; 3. = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.
To measure Clinical attachment level (CAL) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)	measured at the baseline, before the application of drug& after 18 weeks	To measure Clinical attachment level (CAL) in millimeter (mm).
To measure Periodontal Pocket Depth (PPD) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)	measured at the baseline, before the application of drug& after 18 weeks	To measure Periodontal Pocket Depth (PPD) in millimeter (mm).

Secondary Outcome Measures

Name	Time	Method
- Evaluate the releasing profile of minocycline hydrochloride noisome gel and minocycline hydrochloride gel	first day then third day then seventh day lastly after fourteen days	change in number of releasing profile of each drug

Trial Locations

Locations (1)

AinShams University; 🇪🇬 Cairo, Egypt