NCT07374536

Brief Summary

Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes after Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Sep 2025Aug 2026

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 20, 2026

Last Update Submit

January 20, 2026

Conditions

Impact Molar

Keywords

ImpactionMelatoninMandibular 3rd MolarsRadiographic evaluationClinical Evaluation

Outcome Measures

Primary Outcomes (1)

  • Bone density

    Assess relative bone density at the center of the extracted socket using digital periapical radiograph in the center of the socket.

    1 and 4 months postoperatively

Secondary Outcomes (4)

  • Post-operative pain levels

    1, 3 and 7 days Postoperatively

  • Measure Edema scale

    1, 3 and 7 days Postoperatively

  • Measure Maximal Mouth opening (MMO)

    1, 3 and 7 days Postoperatively

  • Measure the incidence of post-operative complications

    1, 3 and 7 days Postoperatively

Study Arms (2)

Control without Melatonin

PLACEBO COMPARATOR

(the extraction socket will be left empty followed by suture of the socket after extraction

Diagnostic Test: ControlDietary Supplement: Melatonin gel

Study with Melatonin

EXPERIMENTAL

3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction

Diagnostic Test: ControlDietary Supplement: Melatonin gel

Interventions

ControlDIAGNOSTIC_TEST

the extraction socket will be left empty followed by suture of the socket after extraction

Control without MelatoninStudy with Melatonin
Melatonin gelDIETARY_SUPPLEMENT

3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction

Control without MelatoninStudy with Melatonin

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Pregnant \& lactating women.
  • Smoker patients.
  • Patients with poor oral hygiene.
  • Patients with bad oral habits as bruxism.
  • Patients with periapical or peri coronal lesions.
  • Patients with aggressive gingivitis or periodontitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Suez Canal University

Ismailia, Egypt, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 28, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

EG(1)