CClinicalTrials.gg
CompletedNCT07103564Updated Aug 5, 2025

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

An interventional study of Immediately placed implant in maxillary premolars with local melatonin application and Immediately placed implant in maxillary premolars without local melatonin application in Dental Implants, Osteoprotegerin and Melatonin, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2024, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Implants
  • Osteoprotegerin
  • Melatonin
03

In context

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    melatonin therapy

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

  • Active comparator
    No melatonin

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

Interventions

  • OtherImmediately placed implant in maxillary premolars with local melatonin application

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

  • OtherImmediately placed implant in maxillary premolars without local melatonin application

    Patients will receive immediately placed implants without local melatonin application.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1 month, and 3 months

  2. Change in bone volume

    CBCT scans will be obtained to measure change in bone volume

    Time frame: Baseline and 6 months

  3. Change in bone level

    CBCT scans will be obtained to measure change in bone level

    Time frame: Baseline and 6 months

  4. Change in bone density

    CBCT scans will be obtained to measure change in bone density

    Time frame: Baseline and 6 months

07

Study locations

1 site
  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
    Alexandria, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07103564
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Lecturer of Dental Public Health and biostatistical consultanat, Alexandria University) — Sponsor-investigator
First posted
Aug 5, 2025
Start date
Jul 1, 2024
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025
Last update
Aug 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion