Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMansoura University
About this trial
The purpose of this study is to evaluate and compare the clinical and radiographic outcomes of using photofunctionalized (UV-treated) dental implants with or without the application of melatonin hormone in the posterior maxilla (upper back jaw).
The posterior maxilla is known to have lower bone quality, which can negatively affect the primary and secondary stability of dental implants,. UV photofunctionalization is a method that modifies the titanium surface of the implant, changing it from hydrophobic (water-repelling) to superhydrophilic (water-attracting). This enhancement aims to accelerate protein adsorption and promote bone-building cells (osteoblasts). On the other hand, melatonin acts as an anti-inflammatory and antioxidant agent that stimulates bone formation and reduces bone resorption.
A total of 21 dental implants will be placed in patients requiring tooth replacement in the posterior maxilla. The implants will be divided into three main approaches: one using UV-treated implants alone, and the other combining UV-treated implants with melatonin. and one using conventional implant Patients will be followed up clinically and radiographically to assess implant stability, bone healing, and overall implant success over time.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged between 18 and 60 years old.
Patients seeking replacement of missed single or multiple teeth in the posterior maxilla.
Sufficient bone volume (height and width) to accommodate dental implant placement without major bone grafting.
Good oral hygiene and motivated patients.
Disqualifiers
Patients with uncontrolled systemic diseases
Patients who received radiation therapy in the head and neck region within the last 5 years.
Heavy smokers (more than 10 cigarettes per day).
Patients with active periodontal disease or poor oral hygiene.
Trial design
Design model
Parallel
Treatments tested in this trial
UV-Photofunctionalized Dental Implant
DeviceCommercial titanium dental implants subjected to ultraviolet (UV) light irradiation immediately prior to surgical placement to convert the surface property from hydrophobic to superhydrophilic.
Conventional Dental Implant
DeviceStandard commercial titanium dental implants placed using traditional surgical protocols without any UV surface photofunctionalization or melatonin application.
Treatment groups
21 Participants
are divided into 3 treatment groupsGroup A: Experimental: UV-Implant + MelatoninExperimental treatment 1 intervention
Group B: Active Comparator: UV-Implant AloneActive comparator 1 intervention
Group C: Conventional Dental ImplantActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Implant Stability (ISQ)
Implant stability will be measured using Resonance Frequency Analysis (RFA) to obtain the Implant Stability Quotient (ISQ) value. Higher ISQ values indicate greater primary and secondary implant stability.
Time frame
At the time of implant placement (baseline), 2, 4, weeks, 3 and 9 monthsSecondary outcomes
1
Marginal Bone Level Changes
Radiographic evaluation using standardized digital periapical radiographs to measure peri-implant marginal bone loss or gain in millimeters.
Time frame
At the time of implant placement (baseline), 3 months, and 9 months post-operatively.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov