The Effect of Melatonin Application Following Removal of Impacted Third Molar

Sponsor

Fayoum University (Other)

Overall Status

Completed

CT.gov ID

NCT04424875

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Impacted Third Molar Tooth	Drug: 3 mg melatonin Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Bone density [6months]
The bone density within the extraction socket was measured using software of cone beam

Secondary Outcome Measures

Osteoprotegerin (OPG) [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
pain sensation [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).
swelling [7 days postoperative]
a tape measure, from the tragus to the corner of the mouth.
trismus [7days postoperative]
measuring the distance between incisal edges of upper and lower central incisor at maximal mouth

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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