Melatonin as an Adjunctive Therapy for Chronic Periodontitis.

NCT03368430 | Completed Phase 4 DMC

• 1 other identifier: DENT-2017
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Melatonin is an endogenous indoleamine synthesized mainly by pineal gland and showed anti-inflammatory and antioxidant properties. Moreover, melatonin promotes osteoblastic differentiation and suppresses osteoclastic formation. This randomized clinical trial (RCT) was aimed to assess the additive effect of melatonin supplementation in generalized chronic periodontitis (gCP) patients with insomnia who received scaling and root planing (SRP). Methods: Seventy four gCP patients with primary insomnia participated in this 6-month RCT and randomly distributed between two groups. Melatonin group (MTN+SRP group, n=38) included patients who were subjected to SRP with a 2- month regimen of 10 mg oral melatonin supplementation capsule once daily at bed-time. In the control group (Placebo+SRP group, n=36), SRP was performed for participants provided with matching placebo capsules. The primary treatment outcome included the clinical attachment gain (CAG) after 3 and 6 months of therapy, whereas, the changes in pocket depth ,bleeding on probing (BOP%) and salivary tumor-necrosis factor-α (TNF-α) levels represented the secondary outcomes.

Conditions

Periodontal Diseases

Keywords

Melatonin; Chronic periodontitis; Host modulation therapy

Outcome Measures

Primary Outcomes (1)

• Change of clinical attachment level (clinical attachment gain).

  Clinical attachment level was assessed at baseline,3 and 6 months after receiving scaling and root planing.

  From baseline to 3 and 6 months.

Secondary Outcomes (3)

• Change of pocket depth.

  From baseline to 3 and 6 months.

• Change of Bleeding on probing.

  From baseline to 3 and 6 months.

• Change of salivary TNF-alpha levels.

  From baseline to 3 and 6 months.

Study Arms (2)

Melatonin

EXPERIMENTAL

10 mg melatonin capsule was given to participants in the test group once per day for only 2 months after performing scaling and root planing (SRP) during the whole 6- month period of the study.

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

Matching placebo capsule was given to the control group once daily for 2 months after receiving scaling and root planing (SRP) during the whole 6- month period of the study.

Drug: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

After performing scaling and root planing (SRP) in the test group, melatonin 10 mg oral capsule was taken once daily at night prior to bedtime for only 2 months during the 6-month study period

Also known as: N-acetyl-5-methoxytryptamine

Melatonin

Placebo DRUG

After finishing scaling and root planing (SRP) in the control group, placebo capsule was taken once daily at bedtime for two months.

Also known as: starch capsule

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients were considered eligible for participation if they had Athens Insomnia Scale (AIS) score ≥ 6.
• Each selected patient should have at least 20 teeth.
• The enrolled patients were diagnosed to have moderate to severe gCP based on Armitage's classification.

You may not qualify if:

• diabetes mellitus.
• smokers.
• individuals having night work shifts.
• cancer patients.
• patients with autoimmune diseases or osteoporosis.
• users of antibiotics or non-steroidal anti-inflammatory drugs within the last 3 months.
• patients who were subjected to any periodontal therapy during the last year.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (23)

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MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis

Interventions

Melatonin; Starch

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Hesham M. El-Sharkawy, PhD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Periodontology and Oral Medicine

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 11, 2017
• Study Start: July 4, 2016
• Primary Completion: June 8, 2017
• Study Completion: September 7, 2017
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

EG (1)