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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bone Loss in Jaw

Intervention / Treatment
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* Drug: Melatonin gel
* Drug: Metformin and melatonin gel
* Drug: placebo gel
* Procedure: scaling and root planning


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: melatonin loaded nanoparticle (test group)<br>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<br>* 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<br>Procedure: scaling and root planning<br>* 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.<br>|
| Active Comparator: melatonin and metformin loaded nanoparticle (test group)<br>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<br>* 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<br>Procedure: scaling and root planning<br>* 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.<br>|
| Placebo Comparator: placebo gel (control group)<br>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<br>* 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.<br>Procedure: scaling and root planning<br>* 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.<br>|
| Other: no gel (control group)<br>13 patients will be treated with only scaling and root planning .. | Procedure: scaling and root planning<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nanoparticles, melatonin, metformin, intra-bony defect