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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07374536
Enrollment
20
Registered
2026-01-28
Start date
2025-09-01
Completion date
2026-08-15
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impact Molar

Keywords

Impaction, Melatonin, Mandibular 3rd Molars, Radiographic evaluation, Clinical Evaluation

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

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).

Interventions

DIAGNOSTIC_TESTControl

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

DIETARY_SUPPLEMENTMelatonin gel

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

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Bone density1 and 4 months postoperativelyAssess relative bone density at the center of the extracted socket using digital periapical radiograph in the center of the socket.

Secondary

MeasureTime frameDescription
Post-operative pain levels1, 3 and 7 days PostoperativelyPost-operative pain levels by VAS (Visual Analog Scale)
Measure Edema scale1, 3 and 7 days PostoperativelyMeasure Edema scale using flexible ruler
Measure Maximal Mouth opening (MMO)1, 3 and 7 days PostoperativelyMeasure Maximal Mouth opening (MMO) using digital caliper.
Measure the incidence of post-operative complications1, 3 and 7 days PostoperativelyMeasure the incidence of post-operative complications (e.g., dry socket, infection) in both groups.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026