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

NCT ID: NCT07003243

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2026-05-31

Brief 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 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).

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.

Conditions

Immediate Implant Placement; Melatonin Production

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Participants receive bone graft + saline only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study group

Participants receive bone graft + 3 mg melatonin + saline

Group Type: EXPERIMENTAL

Local melatonin powder

Intervention Type: DRUG

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.

Interventions

Local melatonin powder

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Ali Mohammed Ali

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

College of Dentistry, University of Baghdad

Baghdad, Baghdad Governorate, Iraq

Countries

Iraq

Central Contacts

Ali Dr Ali, Bachelor

Role: CONTACT

alimguraifi@gmail.com

009647764002342

Other Identifiers

Melatonin in immediate implant

Identifier Type: -

Identifier Source: org_study_id