Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07374536

Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes After Surgical Removal of Impacted Mandibular Third Molar

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Suez Canal University

Ismailia, Egypt

About this study

of all impacted teeth. The frequency of impaction of the mandibular third molar ranges from 33% to 58.7%. A tooth is considered to be impacted when its eruption time has passed or when the eruption interferes with the normal functional occlusion with other teeth or the overlying bone or soft tissues in the oral cavity.

The surgical removal of an impacted third molar is an everyday procedure in oral surgery clinics. However, it is known to disturb the quality of life of the patient by restricting the ability to chew food, open the mouth, and speak. Furthermore, there is a danger of periodontal damage on the distal root of the adjacent molar which could affect healing, 43% of the patients had a periodontal pocket depth of 7 mm or more at the distal root of the mandibular second molar 2 years post extraction of an impacted mandibular third molar.

The healing of periodontal defects related to the distal root of the adjacent molar may be compromised by intra-bony defects and bone loss after the removal of the impacted tooth. Alternative strategies, such as different flap designs, soft-tissue suturing, socket preservation, and tissue regeneration techniques with autologous bone, allografts, xenografts, or alloplastic grafts, have been proposed to prevent periodontal defects and physiological bone resorption after the surgical extraction of the mandibular third molar.

Melatonin is a growth hormone secreted mainly by the pineal gland and other structures, such as the retina, skin, gastrointestinal tract, lymphocytes, and bone marrow.It has antioxidant and anti inflammatory properties. It inhibits the production of reactive oxidants by reducing the expression of cyclooxygenase-2 and prostaglandin. In addition, it attracts polymorphonuclear cells to the site of injury.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1)Both genders are included. 2)Adult patients (18-40) years 3)Healthy American Society of Anesthesiologists ASA I Patients. 4)Patients with class I or II impacted lower third molars with position A or B.

-

Exclusion criteria

  • 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.

Treatment and study plan

Control

Diagnostic Test

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

Melatonin gel

Dietary Supplement

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

Primary outcomes

  1. Bone density

    Time frame: 1 and 4 months postoperatively

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

Secondary outcomes

  1. Post-operative pain levels

    Time frame: 1, 3 and 7 days Postoperatively

    Post-operative pain levels by VAS (Visual Analog Scale) Minimum Score: 0 (no pain) Maximum Score: 10 (severe pain that completely prevent daily activities)

  2. Measure Edema scale

    Time frame: 1, 3 and 7 days Postoperatively

    Measure Edema scale using flexible ruler (It depends on the patient's own facial measurements and returning to normal measurements).

  3. Measure Maximal Mouth opening (MMO)

    Time frame: 1, 3 and 7 days Postoperatively

    Measure Maximal Mouth opening (MMO) using digital caliper.

  4. Measure the incidence of post-operative complications

    Time frame: 1, 3 and 7 days Postoperatively

    Measure the incidence of post-operative complications (e.g., dry socket, infection) in both groups.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.