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Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05759416
Enrollment
40
Registered
2023-03-08
Start date
2020-04-01
Completion date
2021-03-01
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis, Melatonin, RANKL (Receptor activator nuclear K ligand), ELISA (Enzyme-Linked Immunosorbent Assay), Gingival crevicular fluid

Brief summary

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

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.

Interventions

DRUGMelatonin2%gel

Intra-pocket application of 2% Melatonin gel

DRUGPLACEBO

placebo intra-pocket application

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model 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.

Eligibility

Sex/Gender
ALL
Age
19 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Diabetic mellitus immunsuppressive medication

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.2 weekspositive change in clinical parameter by millimeter
EFFICACY of Melatonin Gel by positive change measurements of clinical parameter pocket depth ,attachment loss1: 3 monthspositive change in clinical parameter by millimeter

Secondary

MeasureTime frameDescription
EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)3 monthsmicrobiology analysis by Receptor activator nuclear K ligand(ELISA ) by picogram

Other

MeasureTime frameDescription
pre-opertive measurements of clinical parameter in chronic periodontitisat beginning of trialnegative result in clinical parameter measurments by millimeter

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026