The Effect of Melatonin Application Following Removal of Impacted Third Molar

May 16, 2021 updated by: Shaimaa Mohsen, Fayoum University

Local Melatonin Application Following Removal of an Impacted Mandibular Third Molar: A Randomized Controlled Clinical Trial

In the present study, the main hypothesis hypothesizes that the local application of melatonin in the post-extraction socket produces favorable differences in the immediate postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the natural healing process of the socket.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18ys
  • no systemic disease
  • impacted mandibular third molar class II position B on Pell- Gregory classification

Exclusion Criteria:

  • history of metabolic or systemic diseases affecting bone or healing process,
  • local infection,
  • tobacco use,
  • oral contraceptive,
  • pregnancy and lactation
  • patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: study arm
patients will undergo surgery to remove impacted lower third molar and receive Melatonin (3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%) in the socket following removal of the impacted third molar
Drug: 3 mg melatonin
patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%
Other Names:
  • melatonin group
PLACEBO_COMPARATOR: controlled arm
patients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %).
Drug: Placebo
patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%
Other Names:
  • cellulose group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density
Time Frame: 6months
The bone density within the extraction socket was measured using software of cone beam
6months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteoprotegerin (OPG)
Time Frame: 4weeks postoperatively
Human Osteoprotegerin (OPG) ELISA Kit was used to detect OPG levels.The changes in OPG in the whole group in the predetermined period immediate postoperative , after 4 week,and 6months
4weeks postoperatively
pain sensation
Time Frame: 7 days postoperative
a visual analogue scale (VAS) of 10 units in combination with a graphic rating scale. On the VAS, the left most end represented the absence of pain (score 0) and the right most end indicated the most severe pain (score 10).
7 days postoperative
swelling
Time Frame: 7 days postoperative
a tape measure, from the tragus to the corner of the mouth.
7 days postoperative
trismus
Time Frame: 7days postoperative
measuring the distance between incisal edges of upper and lower central incisor at maximal mouth
7days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

June 7, 2020

First Submitted That Met QC Criteria

June 7, 2020

First Posted (ACTUAL)

June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 16, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Melatonin and 3rd molar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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