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

Suez Canal University

Status: Active, not recruiting

Conditions: Impact Molar

Treatments: Diagnostic Test: Control; Dietary Supplement: Melatonin gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07374536

2025/1006

Details and patient eligibility

About

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

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Control without Melatonin

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Melatonin gel

Diagnostic Test: Control

Study with Melatonin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Melatonin gel

Diagnostic Test: Control