Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

NCT ID: NCT05759416

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Gp I(Melatonin gp)

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 Type ACTIVE_COMPARATOR

Melatonin2%gel

Intervention Type DRUG

Intra-pocket application of 2% Melatonin gel

Gp II(placebo gp)

Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

placebo intra-pocket application

Interventions

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Melatonin2%gel

Intra-pocket application of 2% Melatonin gel

Intervention Type DRUG

PLACEBO

placebo intra-pocket application

Intervention Type DRUG

Other Intervention Names

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intra- pocket Melatonin gel

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Diabetic mellitus immunsuppressive medication
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Shaymaa Hussein Rafat Kotb

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alazhar university ,faculty of Dental Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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kotb, shaymaa Hussein Rafat

Reference Type RESULT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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[email protected]

Identifier Type: REGISTRY

Identifier Source: secondary_id

AADJ-2111-1091

Identifier Type: -

Identifier Source: org_study_id

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