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This randomized controlled triple-blind split-mouth clinical trial was conducted to evaluate the effect of early loading on ultraviolet photofunctionalized dental implants placed in the posterior mandible. Ten patients received a total of 20 implants, with each participant receiving one ultraviolet photofunctionalized implant and one non-photofunctionalized control implant. Ultraviolet photofunctionalization was performed 24 hours before implant placement by an independent investigator. All implants were early loaded 4 weeks after surgery. Implant stability was assessed using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values at implant placement, 3 weeks, and 4 weeks after surgery. Peri-implant marginal bone loss was evaluated radiographically during a one-year follow-up period. The study compared implant stability and radiographic outcomes between ultraviolet photofunctionalized and conventional implants under early loading conditions.
Dental implants have become a predictable and widely accepted treatment modality for the rehabilitation of partially and completely edentulous patients.
Successful implant therapy depends largely on achieving and maintaining osseointegration between the implant surface and the surrounding bone. Traditionally, implants were left unloaded for several months to allow sufficient healing and osseointegration before functional loading. However, the growing demand for shorter treatment times has encouraged the development of early loading protocols. Early loading of dental implants offers several clinical advantages, including reduced treatment duration, earlier restoration of function and esthetics, and improved patient satisfaction. Nevertheless, successful early loading requires adequate implant stability during the critical healing period. Consequently, considerable research has focused on improving implant surface characteristics to accelerate osseointegration and enhance implant stability. Ultraviolet (UV) photofunctionalization is a surface modification technique that involves exposing titanium implants to ultraviolet light before placement. This process reduces hydrocarbon contamination on the implant surface, increases surface hydrophilicity, and enhances the biological activity of titanium. Previous experimental and clinical studies have suggested that UV photofunctionalization may improve cell attachment, promote bone formation, increase bone-to-implant contact, and enhance implant stability during the early stages of healing. This randomized controlled triple-blind split-mouth clinical trial was conducted to evaluate the effect of early loading on ultraviolet photofunctionalized dental implants placed in the posterior mandible. Ten patients requiring bilateral implant-supported rehabilitation in comparable posterior mandibular sites were included. A total of twenty implants were placed, with each participant receiving one ultraviolet photofunctionalized implant and one non photofunctionalized control implant. Implant allocation was randomized, and ultraviolet photofunctionalization was performed by an independent investigator 24 hours before surgery. Participants, the surgeon/outcome assessor, and the statistician were blinded to treatment allocation throughout the study. All implants were restored using an early loading protocol four weeks after implant placement. Implant stability was evaluated using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values. Measurements were obtained at implant placement, three weeks after surgery, and four weeks after surgery. In addition, peri-implant marginal bone loss was assessed radiographically during a one-year follow-up period. The split-mouth design was selected to minimize inter-individual variability and allow direct comparison between test and control implants within the same participant. The study aimed to determine whether ultraviolet photofunctionalization could improve implant stability and support the clinical performance of early-loaded dental implants in the posterior mandible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Ultraviolet Photofunctionalized Dental Implants | Experimental | This arm included dental implants that underwent ultraviolet photofunctionalization 24 hours before implant placement. Each participant received one ultraviolet photofunctionalized implant in a posterior mandibular edentulous site according to the randomized split-mouth design. |
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| Conventional Dental Implants | Active Comparator | This arm included dental implants placed without ultraviolet photofunctionalization. Each participant received one conventional implant in a comparable posterior mandibular edentulous site according to the randomized split-mouth design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultraviolet Photofunctionalization | Procedure | Dental implants assigned to the experimental arm underwent ultraviolet photofunctionalization 24 hours before implant placement by an independent investigator. The implants were subsequently placed in posterior mandibular edentulous sites and restored using an early loading protocol 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability Quotient (ISQ) | Implant stability was measured using Resonance Frequency Analysis (RFA) with the Mega ISQ II device. Stability values were recorded as Implant Stability Quotient (ISQ) scores ranging from 1 to 100, with higher values indicating greater implant stability. Measurements were obtained immediately after implant placement, at 3 weeks, and at 4 weeks postoperatively before early loading. | At implant placement (baseline), 3 weeks after implant placement, and 4 weeks after implant placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-implant Marginal Bone Loss | Peri-implant marginal bone loss was evaluated using standardized periapical radiographs obtained immediately after implant placement and one year after early loading. Measurements were performed by assessing the vertical distance from the implant platform to the first bone-to-implant contact on both mesial and distal aspects of the implant. Bone level changes were calculated and recorded in millimeters (mm), with greater values indicating increased marginal bone loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Issam Alkhouri, DDS, Phd | Faculty of Dentistry, Damascus University, Damascus, Syria | Study Chair |
| Awab Al-Midani, Master's Degree Candidate | Faculty of Dentistry, Damascus University, Damascus, Syria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery Faculty of Dentistry Damascus University Damascus, Syrian Arab Republic | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24066316 | Background | Funato A, Yamada M, Ogawa T. Success rate, healing time, and implant stability of photofunctionalized dental implants. Int J Oral Maxillofac Implants. 2013 Sep-Oct;28(5):1261-71. doi: 10.11607/jomi.3263. | |
| 31116830 | Background | Monje A, Ravida A, Wang HL, Helms JA, Brunski JB. Relationship Between Primary/Mechanical and Secondary/Biological Implant Stability. Int J Oral Maxillofac Implants. 2019 Suppl;34:s7-s23. doi: 10.11607/jomi.19suppl.g1. |
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This study used a randomized split-mouth design in which each participant received one ultraviolet-photofunctionalized implant and one implant that did not undergo ultraviolet treatment in contralateral posterior mandibular sites. This design enabled within-subject comparisons while minimizing inter-individual variability.
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Participants, care providers, investigators, and outcome assessors were blinded to treatment allocation. Ultraviolet photofunctionalization was performed 24 hours before surgery by an independent operator who was not involved in implant placement, follow-up assessments, or data analysis. Implant allocation was concealed using coded assignments. The surgeon who performed implant placement and evaluated implant stability (ISQ) and marginal bone loss remained unaware of group allocation throughout the study. Statistical analyses were conducted using anonymized datasets without disclosure of treatment identities until completion of the final analysis.
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| Conventional Implant Placement | Procedure | Dental implants assigned to the control arm were placed without ultraviolet photofunctionalization. The implants were inserted in comparable posterior mandibular edentulous sites and restored using the same early loading protocol 4 weeks after surgery |
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| At implant placement (baseline) and one year after early loading. |
| 32564392 | Background | Dini C, Nagay BE, Magno MB, Maia LC, Barao VAR. Photofunctionalization as a suitable approach to improve the osseointegration of implants in animal models-A systematic review and meta-analysis. Clin Oral Implants Res. 2020 Sep;31(9):785-802. doi: 10.1111/clr.13627. Epub 2020 Jul 2. |
| 32847061 | Background | Hirota M, Ozawa T, Iwai T, Mitsudo K, Ogawa T. UV-Mediated Photofunctionalization of Dental Implant: A Seven-Year Results of a Prospective Study. J Clin Med. 2020 Aug 24;9(9):2733. doi: 10.3390/jcm9092733. |
| 33969450 | Background | Choi B, Lee YC, Oh KC, Lee JH. Effects of photofunctionalization on early osseointegration of titanium dental implants in the maxillary posterior region: a randomized double-blinded clinical trial. Int J Implant Dent. 2021 May 10;7(1):37. doi: 10.1186/s40729-021-00318-x. |