Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

Al-Azhar University

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis

Treatments: Drug: PLACEBO; Drug: Melatonin2%gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05759416

[e-mail] (Registry Identifier)

AADJ-2111-1091

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Diabetic mellitus immunsuppressive medication

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Gp I(Melatonin gp)

Active Comparator group

Description:

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.

Treatment:

Drug: Melatonin2%gel

Gp II(placebo gp)

Placebo Comparator group

Description:

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

Treatment:

Drug: PLACEBO