The Effect of Melatonin Application Following Removal of Impacted Third Molar

Phase 3

Completed

• Conditions: Impacted Third Molar Tooth
• Interventions: Drug: Placebo; Drug: 3 mg melatonin

• Registration Number: NCT04424875
• Lead Sponsor: Fayoum University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-06-07
• Study First Posted: 2020-06-11
• Study Start: 2020-07-01
• Primary Completion: 2021-03-01
• Status Verified: 2021-05
• Study Completion: 2021-05-01
• Last Update Submitted: 2021-05-16
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controlled arm	Placebo	patients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %).
study arm	3 mg melatonin	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

Primary Outcome Measures

Name	Time	Method
Bone density	6months	The bone density within the extraction socket was measured using software of cone beam

Secondary Outcome Measures

Name	Time	Method
trismus	7days postoperative	measuring the distance between incisal edges of upper and lower central incisor at maximal mouth
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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt