The Effect of Melatonin Application Following Removal of Impacted Third Molar

NCT04424875 | Completed Phase 3

• 1 other identifier: Melatonin and 3rd molar
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

impacted third molar; melatonine; bone healing

Outcome Measures

Primary Outcomes (1)

• Bone density

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

  6months

Secondary Outcomes (4)

• Osteoprotegerin (OPG)

  4weeks postoperatively

• pain sensation

  7 days postoperative

• swelling

  7 days postoperative

• trismus

  7days postoperative

Study Arms (2)

study arm

EXPERIMENTAL

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

controlled arm

PLACEBO COMPARATOR

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

Interventions

3 mg melatonin DRUG

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

Also known as: melatonin group

study arm

Placebo DRUG

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

Also known as: cellulose group

controlled arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 25350595 BACKGROUND

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer,oral surgery

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)