The Effect of Melatonin Application Following Removal of Impacted Third Molar

NCT ID: NCT04424875

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-05-01

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.

Conditions

Impacted Third Molar Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

3 mg melatonin

Intervention Type: DRUG

patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%

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 %).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%

Interventions

3 mg melatonin

patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%

Intervention Type: DRUG

Placebo

patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%

Intervention Type: DRUG

Other Intervention Names

melatonin group; cellulose group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohsen

lecturer,oral surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 25350595 (View on PubMed)

Other Identifiers

Melatonin and 3rd molar

Identifier Type: -

Identifier Source: org_study_id