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

NCT ID: NCT07103564

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-07-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

melatonin therapy

Group Type: EXPERIMENTAL

Immediately placed implant in maxillary premolars with local melatonin application

Intervention Type: OTHER

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

No melatonin

Group Type: ACTIVE_COMPARATOR

Immediately placed implant in maxillary premolars without local melatonin application

Intervention Type: OTHER

Patients will receive immediately placed implants without local melatonin application.

Interventions

Immediately placed implant in maxillary premolars with local melatonin application

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

Intervention Type: OTHER

Immediately placed implant in maxillary premolars without local melatonin application

Patients will receive immediately placed implants without local melatonin application.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Lecturer of Dental Public Health and biostatistical consultanat

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0812-12/2023

Identifier Type: -

Identifier Source: org_study_id