Jaw, Edentulous, PartiallyUV-MEL-IMPLANTNCT07853976
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
A study testing UV-Photofunctionalized Dental Implant and Conventional Dental Implant in people with Jaw, Edentulous, Partially and Bone Resorption, run by Mansoura University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially, Bone Resorption, Dental Implant Failure
- What is being tested?
- UV-Photofunctionalized Dental Implant and Conventional Dental Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2026to 21 Nov 2026
- Phase
- Interventional
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
Official title: Clinical and Radiographic Assessment of Photofunctionalized Dental Implants With or Without Melatonin in the Posterior Maxilla
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.
Read the detailed description
This interventional study is designed to clinically and radiographically evaluate the potential synergistic effects of ultraviolet (UV) photofunctionalized dental implants combined with melatonin hormone in the posterior maxilla, bone density (D4 bone quality) and challenging primary implant stability.
Biological aging of titanium is an unavoidable phenomenon occurring within weeks of manufacturing, where hydrocarbon contamination covers the protective titanium dioxide layer, increasing surface hydrophobicity and reducing optimal osteoblast adhesion. To counteract this, UV photofunctionalization (UV irradiation) will be utilized immediately prior to implant insertion to restore superhydrophilic properties, reduce hydrocarbon content, and enhance early protein adsorption and osteoblastic differentiation.
Additionally, melatonin (N-acetyl-5-methoxytryptamine) will be investigated as an alternative graft or bioactive material. Melatonin exhibits potent anti-inflammatory and antioxidant capabilities, destroys reactive oxygen species, and stimulates human osteoblasts to synthesize type I collagen fibers. It also down-regulates RANKL-mediated osteoclast activation, thereby reducing bone resorption during the critical early healing phases.
Patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, following ethical committee approval and obtaining informed written consents. A total of 21 implants will be placed in the posterior maxilla. The clinical and radiographic evaluation will monitor parameters such as primary and secondary implant stability, marginal bone level changes, and peri-implant tissue health to compare the outcomes of photofunctionalized implants alone against those combined with melatonin.
- Being tested
- UV-Photofunctionalized Dental Implant, Conventional Dental Implant
- Keywords
- photofunctionalized Dental Implants, UV Treatment, Melatonin, Posterior Maxilla, Osseointegration, Implant Stability
- Medical subject headings
- Jaw, Edentulous, Partially, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV-Photofunctionalized Dental ImplantDevice
Commercial 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 ImplantDevice
Standard commercial titanium dental implants placed using traditional surgical protocols without any UV surface photofunctionalization or melatonin application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Conventional Dental Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of implant placement (baseline), 2, 4, weeks, 3 and 9 months
Secondary outcomes (1)
Marginal Bone Level Changes
Radiographic evaluation using standardized digital periapical radiographs to measure peri-implant marginal bone loss or gain in millimeters.
Measured: At the time of implant placement (baseline), 3 months, and 9 months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start21 Feb 2026
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853976
- Sponsor's protocol ID
- MS.26.01.118
- Acronym
- UV-MEL-IMPLANT
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soler G, Bernal-Vicente A, Anton AI, Torregrosa JM, Caparros-Perez E, Sanchez-Serrano I, Martinez-Perez A, Sanchez-Vega B, Vicente V, Ferrer-Marin F. The JAK2 46/1 haplotype does not predispose to CALR-mutated myeloproliferative neoplasms. Ann Hematol. 2015 May;94(5):789-94. doi: 10.1007/s00277-014-2266-y. Epub 2014 Dec 9.
PubMed 25482455Lindquist SG, Braedgaard H, Svenstrup K, Isaacs AM, Nielsen JE; FReJA Consortium. Frontotemporal dementia linked to chromosome 3 (FTD-3)--current concepts and the detection of a previously unknown branch of the Danish FTD-3 family. Eur J Neurol. 2008 Jul;15(7):667-70. doi: 10.1111/j.1468-1331.2008.02144.x. Epub 2008 May 15.
PubMed 18484988Rocchigiani G, Ricci E, Navarro MA, Samol MA, Uzal FA. Leukocyte numbers and intestinal mucosal morphometrics in horses with no clinical intestinal disease. J Vet Diagn Invest. 2022 May;34(3):389-395. doi: 10.1177/10406387211031944. Epub 2021 Jul 23.
PubMed 34293980Tian X, Raina DB, Vater C, Kilian D, Ahlfeld T, Platzek I, Nimtschke U, Tagil M, Lidgren L, Thomas A, Platz U, Schaser KD, Disch AC, Zwingenberger S. Evaluation of an Injectable Biphasic Calcium Sulfate/Hydroxyapatite Cement for the Augmentation of Fenestrated Pedicle Screws in Osteoporotic Vertebrae: A Biomechanical Cadaver Study. J Funct Biomater. 2022 Dec 1;13(4):269. doi: 10.3390/jfb13040269.
PubMed 36547529Chen DW, Yu HH, Luo LJ, Rajesh Kumar S, Chen CH, Lin TY, Lai JY, Jessie Lue S. Osteoblast Biocompatibility and Antibacterial Effects Using 2-Methacryloyloxyethyl Phosphocholine-Grafted Stainless-Steel Composite for Implant Applications. Nanomaterials (Basel). 2019 Jun 28;9(7):939. doi: 10.3390/nano9070939.
PubMed 31261737Lang X, Qiao B, Ge Z, Yan J, Zhang Y. Clinical Effects of Photofunctionalization on Implant Stability and Marginal Bone Loss: Systematic Review and Meta-Analysis. J Clin Med. 2022 Nov 28;11(23):7042. doi: 10.3390/jcm11237042.
PubMed 36498616Lee D, Lee JS, Sezirahiga J, Kwon HC, Jang DS, Kang KS. Bioactive Phytochemicals Isolated from Akebia quinata Enhances Glucose-Stimulated Insulin Secretion by Inducing PDX-1. Plants (Basel). 2020 Aug 24;9(9):1087. doi: 10.3390/plants9091087.
PubMed 32847055Nganda B, Wang'ombe J, Floyd K, Kangangi J. Cost and cost-effectiveness of increased community and primary care facility involvement in tuberculosis care in Machakos District, Kenya. Int J Tuberc Lung Dis. 2003 Sep;7(9 Suppl 1):S14-20.
PubMed 12971650Matsuo T, Mori N, Sakurai A, Furukawa K. Varicella-zoster virus myeloencephalitis. IDCases. 2017 Oct 20;10:110-111. doi: 10.1016/j.idcr.2017.10.006. eCollection 2017. No abstract available.
PubMed 29124011Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. doi: 10.1111/j.1365-2648.2003.02972.x.
PubMed 15056325