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ClinicalTrials.gov ID

NCT06255067

Lead Sponsor

Ain Shams UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2Phase 3

Enrollment

30Estimated

Last Update Posted

Feb 12, 2024Actual

Start Date

Feb 25, 2024Estimated

Primary Completion Date

May 25, 2024Estimated

Completion Date

Jun 30, 2024Estimated

Official Title

"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"

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.

• Periodontitis

• Minocycline hydrochloride with noisome carrier
• Minocycline Hydrochloride only

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 .

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Tanta UniversityOTHER

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