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

Amira ragab

Status and phase

Invitation-only

Phase 2

Conditions

Bone Loss in Jaw

Treatments

Drug: placebo gel

Drug: Melatonin gel

Drug: Metformin and melatonin gel

Procedure: scaling and root planning

Study type

Interventional

Funder types

Other

Identifiers

NCT05906563

A06011122

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

patients with at least one intra-bony defect diagnosed clinically and radiographically

Exclusion criteria

Patients with systemic diseases.
Pregnant and lactating females.
Smokers and tobacco chewers.
History of antibiotic and periodontal therapy in the last 3 months.
Patients not compliant with oral hygiene procedures.
Patients with a known or suspected allergy to the melatonin or metformin.
Individuals on systemic drug affecting metabolic bone diseases and medically compromised patients.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

52 participants in 4 patient groups, including a placebo group

melatonin loaded nanoparticle (test group)

Active Comparator group

Description:

13 patients will be treated with melatonin loaded nanoparticle gel as adjunct to scaling and root planning .it will be applied once weekly for four weeks.

Treatment:

Drug: Melatonin gel

Procedure: scaling and root planning

melatonin and metformin loaded nanoparticle (test group)

Active Comparator group

Description:

13 patients will be treated with melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks.

Treatment:

Drug: Metformin and melatonin gel

Procedure: scaling and root planning

placebo gel (control group)

Placebo Comparator group

Description:

13 patients will be treated with placebo gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks.

Treatment:

Drug: placebo gel

Procedure: scaling and root planning

no gel (control group)

Other group