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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bone Loss in Jaw
• Intervention / Treatment: Drug: Melatonin gel; Procedure: scaling and root planning; Drug: Metformin and melatonin gel; Drug: placebo gel

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Dakhlia
    • Mansoura, Dakhlia, Egypt, 35516
      • Amira R agab AL-agooz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: melatonin loaded nanoparticle (test group); 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; 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; 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.
Active Comparator: melatonin and metformin loaded nanoparticle (test group); 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.	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.; 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
Placebo Comparator: placebo gel (control group); 13 patients will be treated with placebo gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks.	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.; 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.
Other: no gel (control group); 13 patients will be treated with only scaling and root planning ..	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
plaque index according to Silness P.Loe H 1964	Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria: The Plaque Index System 0 No plaque; A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.; Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.; Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival bleeding index(GBI - Ainamo & Bay, 1975)	is performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined.	6 months
Probing Pocket depth (PPD)	Is measured from free gingival margin to base of the pocket	6 months
Clinical Attachment level (CAL)	Is measured from cementoenamel junction to base of the pocket	6 months

Collaborators and Investigators

• Sponsor: Amira ragab
• Investigators: Principal Investigator: Amira R AL-Agooz, Mansoura University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Estimated): June 16, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: melatonin; metformin; nanoparticles; intra-bony defect
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin; Metformin
• Other Study ID Numbers: A06011122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No