AzTrials
AzTrials

Immediate Implant PlacementPhase 1NCT07003243

Effectiveness of Topical Application of Melatonin On Bone Density and Implant Stability In Immediate Implantation

A Phase 1 study testing Local melatonin powder in people with Immediate Implant Placement and Melatonin Production, run by University of Baghdad at 1 site in Iraq.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Dental implants have revolutionized the replacement of missing teeth, offering predictable and long-lasting rehabilitation for both fully and partially edentulous patients. Since Brånemark's landmark work in 1969, which defined osseointegration as "a direct structural and functional connection between ordered living… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Local melatonin powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteIraq
Study dates
26 May 2025to May 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 years and older.
  • Presence of single-rooted non-restorable anterior or premolar teeth indicated for extraction.
  • Jumping gap ≥ 2 mm as measured clinically or radiographically.
  • Apical bone ≥ 2 mm beyond the socket on radiographs.
  • Good general health with no contraindications for oral surgery.
  • Patient willing to undergo immediate implant placement.
  • Ability and willingness to return for follow-up visits.
  • Provided written informed consent.

Who cannot join

  • Presence of active periodontal disease or acute infection at the surgical site.
  • Patients with systemic conditions that could compromise healing (e.g., uncontrolled diabetes, immune compromise).
  • History of bisphosphonate therapy.
  • Head and neck irradiation.
  • Pregnancy or lactation.
  • Heavy smokers (≥20 cigarettes/day).
  • -Bruxism or parafunctional habits.
  • Inability to comply with study protocol or follow-up schedule.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ali Dr Ali, Bachelor contact

009647764002342

alimguraifi@gmail.com

Iraq1 site
  • College of Dentistry, University of Baghdad

    Baghdad, Baghdad Governorate, 10001

Other trials in Iraq

About this study

Dental implants have revolutionized the replacement of missing teeth, offering predictable and long-lasting rehabilitation for both fully and partially edentulous patients. Since Brånemark's landmark work in 1969, which defined osseointegration as "a direct structural and functional connection between ordered living bone and the surface of a load-bearing implant" (Brånemark et al., 1969), implantology has become an integral part of restorative dentistry.

Traditionally, implant therapy followed a delayed protocol requiring a healing period of up to six months after extraction to allow complete soft and hard tissue regeneration before implant placement (Adell et al., 1981). This approach was based on the belief that mature bone is essential for achieving osseointegration. However, subsequent research demonstrated that immediate placement of implants into fresh extraction sockets can also lead to successful osseointegration without compromising outcomes (Araujo et al., 2005).

Read more

Immediate implant placement, defined as placing an implant at the time of tooth extraction, has gained popularity due to its clinical benefits. These include a reduction in surgical sessions, shortened overall treatment time, preservation of the alveolar ridge, especially the buccal plate, and superior soft tissue esthetics (Van Der Weijden et al., 2009). However, these advantages are contingent upon achieving primary implant stability and proper case selection. A biological challenge that often arises in such cases is the presence of a "jumping gap" - a void between the implant surface and the socket wall - which may require the use of bone grafts or regenerative materials to facilitate bone fill and stability.

In recent years, research has explored various biologically active molecules and growth factors to enhance bone healing and implant integration, especially in immediate placement protocols. These include bone morphogenetic proteins (BMPs), platelet-rich plasma (PRP), and platelet-derived growth factors. Among these, melatonin has emerged as a promising agent due to its multifaceted biological activity (Zechner et al., 2003).

Melatonin (N-acetyl-5-methoxytryptamine) is an endogenously produced neurohormone primarily secreted by the pineal gland. While best known for regulating circadian rhythms, melatonin also possesses strong antioxidant, anti-inflammatory, and bone-promoting properties. It enhances osteoblast proliferation, stimulates collagen matrix formation, and inhibits osteoclast-mediated bone resorption. These effects make melatonin a potential therapeutic agent for improving bone density and implant stability.

Topical application of melatonin at implant sites has shown encouraging results in experimental models, demonstrating improved bone-to-implant contact, accelerated bone regeneration, and enhanced mechanical stability. These findings suggest a potential role for melatonin in immediate implant protocols, where rapid healing and early osseointegration are critical for clinical success.

Given the biological potential of melatonin, the present study aims to evaluate the effectiveness of topical application of melatonin on bone density and implant stability in immediate implantation cases through a randomized controlled clinical trial.

Being tested
Local melatonin powder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local melatonin powderDrug

    A single topical dose of 3 mg of pure melatonin powder was mixed with particulate bone graft and normal saline, then packed into the jumping gap around immediately placed dental implants. The intervention was performed at the time of surgery following atraumatic tooth extraction. The aim was to enhance osseointegration and minimize crestal bone loss over a 6-month healing period.

Study groups in NCT07003243
Study groupRoleWhat they receive
Control groupNo interventionParticipants receive bone graft + saline only
Study groupExperimentalParticipants receive bone graft + 3 mg melatonin + saline
Receives: Drug: Local melatonin powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in crestal bone level around dental implants

    Radiographic measurement of vertical crestal bone loss using cone-beam computed tomography (CBCT) at baseline and after 6 months to assess the effect of topical melatonin application on bone preservation.

    Measured: Baseline (Day 0) and 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start26 May 2025 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07003243
Sponsor's protocol ID
Melatonin in immediate implant
Status last verified
May 2025
First submitted
20 May 2025
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Local melatonin powder in people with Immediate Implant Placement and Melatonin Production, run by University of Baghdad at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ali Dr Ali, Bachelor (009647764002342, alimguraifi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in crestal bone level around dental implants (time frame: Baseline (Day 0) and 6 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in