Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw

NCT07853976 | Recruiting

• 1 other identifier: MS.26.01.118
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Jaw, Edentulous, Partially; Bone Resorption; Dental Implant Failure

Keywords

photofunctionalized Dental Implants; UV Treatment; Melatonin; Posterior Maxilla; Osseointegration; Implant Stability

Outcome Measures

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.

  At the time of implant placement (baseline), 2, 4, weeks, 3 and 9 months

Secondary Outcomes (1)

• Marginal Bone Level Changes

  At the time of implant placement (baseline), 3 months, and 9 months post-operatively.

Study Arms (3)

Experimental: UV-Implant + Melatonin

EXPERIMENTAL

Patients in this group will receive ultraviolet (UV) photofunctionalized dental implants combined with the topical application of melatonin hormone at the implant site in the posterior maxilla to evaluate early bone formation.

Device: UV-Photofunctionalized Dental Implant

Active Comparator: UV-Implant Alone

ACTIVE COMPARATOR

Patients in this group will receive ultraviolet (UV) photofunctionalized dental implants alone without the application of melatonin hormone in the posterior maxilla to serve as the active control group.

Device: UV-Photofunctionalized Dental Implant

Conventional Dental Implant

ACTIVE COMPARATOR

Patients in this group will receive conventional titanium dental implants in the posterior maxilla to serve as the baseline control group.

Device: Conventional Dental Implant

Interventions

UV-Photofunctionalized Dental Implant DEVICE

Commercial titanium dental implants subjected to ultraviolet (UV) light irradiation immediately prior to surgical placement to convert the surface property from hydrophobic to superhydrophilic.

Active Comparator: UV-Implant Alone; Experimental: UV-Implant + Melatonin

Conventional Dental Implant DEVICE

Standard commercial titanium dental implants placed using traditional surgical protocols without any UV surface photofunctionalization or melatonin application.

Conventional Dental Implant

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Systemically healthy patients with no contraindications for minor oral surgery.

You may not qualify if:

• 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.
• Pregnant or lactating females.
• Parafunctional habits such as severe bruxism or clenching.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

Related Publications (10)

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  PMID: 31261737 BACKGROUND

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MeSH Terms

Conditions

Jaw, Edentulous, Partially; Bone Resorption

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases; Bone Diseases

Central Study Contacts

Ali K Ali, BDS

CONTACT

00201553005571; ak3605773@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is single-blinded. The outcomes assessor responsible for radiographic and statistical data analysis will be blinded to the treatment assignment of each implant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel-group clinical trial where the 21 dental implants will be assigned to either the experimental group (UV-treated implants with melatonin application) or the active control group (UV-treated implants alone) or conventional implant group in the posterior maxilla.

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start: February 21, 2026
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

EG (1)