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The Effect of Melatonin Application Following Removal of Impacted Third Molar

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
3 mg melatonin
Placebo
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Impacted Third Molar Tooth focused on measuring impacted third molar, melatonine, bone healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study arm

controlled arm

Arm Description

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

patients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %).

Outcomes

Primary Outcome Measures

Bone density
The bone density within the extraction socket was measured using software of cone beam

Secondary Outcome Measures

Osteoprotegerin (OPG)
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
pain sensation
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).
swelling
a tape measure, from the tragus to the corner of the mouth.
trismus
measuring the distance between incisal edges of upper and lower central incisor at maximal mouth

Full Information

First Posted
June 7, 2020
Last Updated
May 16, 2021
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT04424875
Brief Title
The Effect of Melatonin Application Following Removal of Impacted Third Molar
Official Title
Local Melatonin Application Following Removal of an Impacted Mandibular Third Molar: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
impacted third molar, melatonine, bone healing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study arm
Arm Type
Experimental
Arm Description
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
Arm Title
controlled arm
Arm Type
Placebo Comparator
Arm Description
patients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %).
Intervention Type
Drug
Intervention Name(s)
3 mg melatonin
Other Intervention Name(s)
melatonin group
Intervention Description
patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
cellulose group
Intervention Description
patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%
Primary Outcome Measure Information:
Title
Bone density
Description
The bone density within the extraction socket was measured using software of cone beam
Time Frame
6months
Secondary Outcome Measure Information:
Title
Osteoprotegerin (OPG)
Description
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
Time Frame
4weeks postoperatively
Title
pain sensation
Description
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).
Time Frame
7 days postoperative
Title
swelling
Description
a tape measure, from the tragus to the corner of the mouth.
Time Frame
7 days postoperative
Title
trismus
Description
measuring the distance between incisal edges of upper and lower central incisor at maximal mouth
Time Frame
7days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25350595
Citation
Cobo-Vazquez C, Fernandez-Tresguerres I, Ortega-Aranegui R, Lopez-Quiles J. Effects of local melatonin application on post-extraction sockets after third molar surgery. A pilot study. Med Oral Patol Oral Cir Bucal. 2014 Nov 1;19(6):e628-33. doi: 10.4317/medoral.19851.
Results Reference
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The Effect of Melatonin Application Following Removal of Impacted Third Molar

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