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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Impact Molar
• Intervention / Treatment: Diagnostic test: Control; Dietary supplement: Melatonin gel

Detailed Description

of all impacted teeth. The frequency of impaction of the mandibular third molar ranges from 33% to 58.7% (Breik O and Grubor D.,2008). 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 (Celikoglu et al.,2010)).

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 (Lago-Mendez et al., 2007). Furthermore, there is a danger of periodontal damage on the distal root of the adjacent molar which could affect healing (Richardson et al., 2005), 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 (Toledano-Serrabona et al.,2021).

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 (Radogna et al.,2010).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 (Cutando et al.,2007).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Egypt
    • Ismailia, Egypt, Egypt
      • Faculty of Dentistry Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

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Exclusion Criteria:

1. Pregnant & lactating women.
2. Smoker patients.
3. Patients with poor oral hygiene.
4. Patients with bad oral habits as bruxism.
5. Patients with periapical or peri coronal lesions.
6. Patients with aggressive gingivitis or periodontitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control without Melatonin; (the extraction socket will be left empty followed by suture of the socket after extraction	Diagnostic test: Control; the extraction socket will be left empty followed by suture of the socket after extraction; Dietary supplement: Melatonin gel; 3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction
Experimental: Study with Melatonin; 3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction	Diagnostic test: Control; the extraction socket will be left empty followed by suture of the socket after extraction; Dietary supplement: Melatonin gel; 3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain levels	Post-operative pain levels by VAS (Visual Analog Scale)	1, 3 and 7 days Postoperatively
Measure Edema scale	Measure Edema scale using flexible ruler	1, 3 and 7 days Postoperatively
Measure Maximal Mouth opening (MMO)	Measure Maximal Mouth opening (MMO) using digital caliper.	1, 3 and 7 days Postoperatively
Measure the incidence of post-operative complications	Measure the incidence of post-operative complications (e.g., dry socket, infection) in both groups.	1, 3 and 7 days Postoperatively

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Melatonin; Radiographic evaluation; Impaction; Clinical Evaluation; Mandibular 3rd Molars
• Other Study ID Numbers: 2025/1006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No