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Melatonin as an Adjunctive Therapy for Chronic Periodontitis.

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ClinicalTrials.gov Identifier: NCT03368430
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hesham El-Sharkawy, Mansoura University

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.


Condition or disease Intervention/treatment Phase
Periodontal Diseases Dietary Supplement: Melatonin Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Is Dietary Melatonin Supplementation a Viable Adjunctive Therapy for Chronic Periodontitis? A Preliminary Randomized Clinical Trial.
Actual Study Start Date : July 4, 2016
Actual Primary Completion Date : June 8, 2017
Actual Study Completion Date : September 7, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin
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
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
Other Name: N-acetyl-5-methoxytryptamine

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




Primary Outcome Measures :
  1. Change of clinical attachment level (clinical attachment gain). [ Time Frame: From baseline to 3 and 6 months. ]
    Clinical attachment level was assessed at baseline,3 and 6 months after receiving scaling and root planing.


Secondary Outcome Measures :
  1. Change of pocket depth. [ Time Frame: From baseline to 3 and 6 months. ]
    Pocket depth was measured at baseline,3 and 6 months.

  2. Change of Bleeding on probing. [ Time Frame: From baseline to 3 and 6 months. ]
    Bleeding on probing (0 for absent and 1 for present) was evaluated at baseline and after 3 and 6 months of therapy.

  3. Change of salivary TNF-alpha levels. [ Time Frame: From baseline to 3 and 6 months. ]
    Salivary TNF-alpha levels were measured at baseline and after 3 and 6 months of therapy.



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368430


Locations
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Egypt
Faculty of Dentistry
Mansourah, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Hesham M. El-Sharkawy, PhD Mansoura University

Publications:

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Responsible Party: Hesham El-Sharkawy, Associate Professor of Periodontology and Oral Medicine, Mansoura University
ClinicalTrials.gov Identifier: NCT03368430     History of Changes
Other Study ID Numbers: DENT-2017
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be shared after publication of the RCT.

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Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Hesham El-Sharkawy, Mansoura University:
Melatonin; Chronic periodontitis; Host modulation therapy

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants