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
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).
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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
- 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.
- Change of pocket depth. [ Time Frame: From baseline to 3 and 6 months. ]Pocket depth was measured at baseline,3 and 6 months.
- 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.
- 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.
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
|Faculty of Dentistry|
|Mansourah, Dakahlia, Egypt|
|Principal Investigator:||Hesham M. El-Sharkawy, PhD||Mansoura University|