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

Ain Shams University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Periodontitis

Treatments: Drug: Minocycline Hydrochloride only; Drug: Minocycline hydrochloride with noisome carrier

Study type: Interventional

Funder types: Other

Identifiers

NCT06255067

FDASU-RecIM022002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups

Minocycline hydrochloride with noisome as carrier

Experimental group

Description:

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

Treatment:

Drug: Minocycline hydrochloride with noisome carrier

Minocycline hydrochoride only

Active Comparator group

Description:

Group II (Minocycline hydrochloride only) 15 patients will receive the drug (Minocycline hydrochloride only gel) at intervals 1,3,7\&14 days

Treatment:

Drug: Minocycline Hydrochloride only