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Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects

NCT05906563 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-06-18

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the effectiveness of local delivery of melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning (SRP) in the treatment of periodontal intra bony defect.

fifty two healthy patients(n=52) with at least one periodontal intra-bony defect will be included in the study, all selected patients will be motivated about the benefit of plaque control and periodontal treatment . The participant will be selected from outpatient clinic of the Department of Oral Medicine and Periodontology , Faculty of dentistry, Mansoura University . The participant will be classified into four groups :group I and II are test groups but group III and IV are control groups .Patients in group I will be treated with melatonin loaded nanoparticle gel while in group II will be treated with melatonin and metformin loaded nanoparticles which will be applied weekly for four weeks after SRP had been completed and group III will be treated with placebo gel while group IV will be treated with only scaling and root planning.

Conditions

  • Bone Loss in Jaw

Interventions

DRUG

Melatonin gel

local application of Melatonin gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack

DRUG

Metformin and melatonin gel

local application of Metformin and melatonin gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack

DRUG

placebo gel

Local application of empty nanoparticles gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack.

PROCEDURE

scaling and root planning

full mouth supra- and subgingival scaling and root planning will be performed, and all periodontitis patients will be treated with ultrasonic tips and Gracey curettes for meticulous removal of subgingival and supragingival plaque and calculus.

Sponsors & Collaborators

  • Amira ragab

    lead OTHER

Principal Investigators

  • Amira R AL-Agooz · Mansoura University, Faculty of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2024-05-31
Completion
2024-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906563 on ClinicalTrials.gov