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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07103564
Enrollment
24
Registered
2025-08-05
Start date
2024-07-01
Completion date
2025-07-15
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants, Melatonin, Osteoprotegerin

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.

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.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in OsteoprotegerinBaseline, 1 month, and 3 monthsOPG (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.
Change in bone volumeBaseline and 6 monthsCBCT scans will be obtained to measure change in bone volume
Change in bone levelBaseline and 6 monthsCBCT scans will be obtained to measure change in bone level
Change in bone densityBaseline and 6 monthsCBCT scans will be obtained to measure change in bone density

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026