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Completed

NCT Number: NCT07103564

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

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.

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Key information

Conditions

Dental Implants Melatonin Osteoprotegerin

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediately placed implant in maxillary premolars with local melatonin application

Other

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

Immediately placed implant in maxillary premolars without local melatonin application

Other

Patients will receive immediately placed implants without local melatonin application.

Primary outcomes

  1. Change in Osteoprotegerin

    Time frame: Baseline, 1 month, and 3 months

    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.

  2. Change in bone volume

    Time frame: Baseline and 6 months

    CBCT scans will be obtained to measure change in bone volume

  3. Change in bone level

    Time frame: Baseline and 6 months

    CBCT scans will be obtained to measure change in bone level

  4. Change in bone density

    Time frame: Baseline and 6 months

    CBCT scans will be obtained to measure change in bone density

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

The Evaluation of the Effect of Local Melatonin Application Around Immediately Placed Implants in the Maxillary Premolars (Randomized Controlled Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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