The Effect of Local Melatonin Application Around Immediately Placed Implants in the Maxillary Premolar

NCT07103564 | Completed

• 1 other identifier: 0812-12/2023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Immediate implants provide ideal three-dimensional positioning compared to conventional implants. There may be a gap between the surface of the implant and the bone walls of the socket when it is inserted into a recently extracted alveolus. To compensate for this, various grafting materials are used. Recently, melatonin has gained significant attention because of its inhibitory action on bone resorption through upregulating the expression of osteoprotegerin, which acts as a decoy receptor for RANKL and inhibits its binding to osteoclast precursors thereby inhibiting osteoclast formation and activity. So, we will conduct this study to evaluate the effects of local melatonin application around immediately placed implants. Aim of the study: To evaluate the effectiveness of adding local melatonin around immediately placed implants in maxillary premolars.

Conditions

Dental Implants; Osteoprotegerin; Melatonin

Outcome Measures

Primary Outcomes (4)

• Change in Osteoprotegerin

  OPG (Ng/ml) level will be measured preoperatively, 1 and 3 months post operatively, to evaluate the bone healing activity. The level will be evaluated by collecting 5 ml of peripheral blood in blank tubes and will be allowed for complete clotting and will be centrifuged at 1000 g for 15 min. The separated serum will be then stored at -20 0C.

  Baseline, 1 month, and 3 months

• Change in bone volume

  CBCT scans will be obtained to measure change in bone volume

  Baseline and 6 months

• Change in bone level

  CBCT scans will be obtained to measure change in bone level

  Baseline and 6 months

• Change in bone density

  CBCT scans will be obtained to measure change in bone density

  Baseline and 6 months

Study Arms (2)

melatonin therapy

EXPERIMENTAL

Other: Immediately placed implant in maxillary premolars with local melatonin application

No melatonin

ACTIVE COMPARATOR

Other: Immediately placed implant in maxillary premolars without local melatonin application

Interventions

Immediately placed implant in maxillary premolars with local melatonin application OTHER

Patients will receive immediately placed implants with local melatonin powder (3mg) application.

melatonin therapy

Immediately placed implant in maxillary premolars without local melatonin application OTHER

Patients will receive immediately placed implants without local melatonin application.

No melatonin

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with non-restorable maxillary premolars with sufficient bone quantity to receive the dental implant without the need for bone graft.
• Patients with no local or systemic pathology that can interfere with normal wound healing.
• Non-smokers.
• Patients who are properly motivated to complete follow-up visits

You may not qualify if:

• Patients with uncontrolled medical conditions that can affect surgical outcome or bone and wound healing. (ex: uncontrolled diabetes mellitus)
• Patients with periapical pathology that may contraindicate immediate implant placement.
• History of receiving irradiation in the head and neck region

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, 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 INVESTIGATOR
• PI Title: Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: July 1, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

EG (1)