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Effect of Topical Melatonin Application on Dental Implant Osseointegration and Marginal Bone Level

NCT04229719 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-10-06

No results posted yet for this study

Summary

Background: Melatonin (N-acetyl-5-methoxy-tryptamine) is an indoleamine synthesized and secreted by the pineal gland and other organs, such as the retina, bone marrow, and intestines in a circadian pattern. Some authors claimed that Melatonin induces bone formation, increase bone density, and bone implant contact. According to animal and human studies the melatonin can be used topically during implant placement to increase bone implant contact and reduce marginal bone loss.

Purpose: The aim of this study was to evaluate the effect of the topical administration of melatonin on osseointegration of dental implants and in minimize marginal bone loss.

Materials and Methods: Twenty single-piece endosseous implants (Dentium Co, Korea) will use to restore missing lower teeth from canine to first molar area. The study will be split-mouth technique, each patient serve as his own control (served into 2 groups), the study side (topical application of melatonin in the implant side), and the control side (no melatonin in the other implant side of the same patients).The primary and secondary stability of dental implant will be evaluated by periotest M device and measure bone level as baseline immediately after implant placement and after 6 months follow up by CBCT.

Conditions

  • Alveolar Bone Loss

Interventions

DRUG

N-acetyl-5-methoxytryptamine

1.2 mg of melatonin powder will place in the osteotomy site before the insertion of the implant.

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-06-01
Completion
2020-11-01

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04229719 on ClinicalTrials.gov