NCT05906563

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

Clinical and Radiographic Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects: A Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Amira ragab · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-12-14
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2023-06-18
• Last updated: 2023-06-18

Locations

1 site across 1 country: Egypt