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

NCT05906563 | Unknown Phase 2 DMC

• 1 other identifier: A06011122
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nanoparticles; melatonin; metformin; intra-bony defect

Outcome Measures

Primary Outcomes (1)

• Radiographic assessment

  all the radiographic parameters will be measured on cone beam computed radiography (CBCT) .The depth of intra bony defect will be measured from cemento enamel junction(CEJ) to base of the defect (BD).The Height of the defect from CEJ to the crest of bone adjacent to the defect and the width of the defect will be from highest point of alveolar crest to dental root adjacent to defect .

  all the parameter will be evaluated after 6 months

Secondary Outcomes (1)

• plaque index according to Silness P.Loe H 1964

  6 months

Other Outcomes (3)

• Gingival bleeding index(GBI - Ainamo & Bay, 1975)

  6 months

• Probing Pocket depth (PPD)

  6 months

• Clinical Attachment level (CAL)

  6 months

Study Arms (4)

melatonin loaded nanoparticle (test group)

ACTIVE COMPARATOR

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.

Drug: Melatonin gel; Procedure: scaling and root planning

melatonin and metformin loaded nanoparticle (test group)

ACTIVE COMPARATOR

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.

Drug: Metformin and melatonin gel; Procedure: scaling and root planning

placebo gel (control group)

PLACEBO COMPARATOR

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

Drug: placebo gel; Procedure: scaling and root planning

no gel (control group)

OTHER

13 patients will be treated with only scaling and root planning ..

Procedure: scaling and root planning

Interventions

Melatonin gel DRUG

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

melatonin loaded nanoparticle (test group)

Metformin and melatonin gel DRUG

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

melatonin and metformin loaded nanoparticle (test group)

placebo gel DRUG

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.

placebo gel (control group)

scaling and root planning PROCEDURE

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.

melatonin and metformin loaded nanoparticle (test group); melatonin loaded nanoparticle (test group); no gel (control group); placebo gel (control group)

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amira ragab: lead

Study Sites (1)

Amira R agab AL-agooz

Al Mansurah, Dakhlia, 35516, Egypt

Location

MeSH Terms

Interventions

Metformin; Tooth Exfoliation

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Amira R AL-Agooz

  Mansoura University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: triple blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: BDS, clinical demonstrator, Oral Medicine, Periodontology, Diagnosis and Oral Radiology Department

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: June 18, 2023
• Study Start: December 14, 2022
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

EG (1)