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NCT Number: NCT05759416

Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

This study was conducted to assess the benefit of locally delivered melatonin gel as adjunctive to scaling and root planning (SRP) in the treatment of chronic periodontitis.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Osteopetrosis, mild autosomal recessive form Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

19 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alazhar university ,faculty of Dental Medicine

Asyut, 0000, Egypt

About this study

Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month. The periodontal parameters were recorded at baseline, 1week, 1and 3 months.Gingival crevicular fluid (GCF) samples were collected and a quantitative measurement of receptor activator nuclear K ligand (RANKL) was carried out by using Enzyme-Linked Immunosorbent Assay (ELISA) at baseline, 1week, 1 and 3 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene

Exclusion criteria

Diabetic mellitus immunsuppressive medication

Treatment and study plan

Melatonin2%gel

Drug

Intra-pocket application of 2% Melatonin gel

Other names: intra- pocket Melatonin gel

Placebo

Drug

placebo intra-pocket application

Primary outcomes

  1. Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.

    Time frame: 2 weeks

    positive change in clinical parameter by millimeter

  2. EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"

    Time frame: 1: 3 months

    positive change in clinical parameter by millimeter

Secondary outcomes

  1. EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)

    Time frame: 3 months

    microbiology analysis by Receptor activator nuclear K ligand(ELISA ) by picogram

Other outcomes

  1. pre-opertive measurements of clinical parameter in chronic periodontitis

    Time frame: at beginning of trial

    negative result in clinical parameter measurments by millimeter

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of the Efficacy of Topically Applied Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis; Randomized Control Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 8, 2023
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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