Clinical trial NCT05759416: Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis
Official title: Evaluation of the Efficacy of Topically Applied Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis; Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis
Melatonin
RANKL (Receptor activator nuclear K ligand)
ELISA (Enzyme-Linked Immunosorbent Assay)
Gingival crevicular fluid
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Diabetic mellitus immunsuppressive medication

Primary outcomes:
measure: Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.
timeFrame: 2 weeks
measure: EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"
timeFrame: 1: 3 months
Secondary outcomes:
measure: EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)
timeFrame: 3 months
Other outcomes:
measure: pre-opertive measurements of clinical parameter in chronic periodontitis
timeFrame: at beginning of trial
Locations:
city: Assiut
country: Egypt
facility: Alazhar university ,faculty of Dental Medicine
Study officials:
References:
citation: kotb, shaymaa Hussein Rafat