Posterior Mandibular Partial Edentulism
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREUltraviolet Photofunctionalization
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
PROCEDUREConventional Implant Placement
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
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willingness to participate in the study and provision of written informed consent, with commitment to follow-up visits and study instructions. 2. Good oral hygiene and satisfactory oral health status. 3. Adults aged 18 years or older. 4. Good general health with no systemic conditions contraindicating dental implant placement. 5. Requirement for dental implant placement in the posterior mandible, with at least 6 months elapsed since tooth extraction. 6. Adequate bone volume to allow implant placement without the need for bone grafting procedures.
Exclusion criteria
1. Patients with parafunctional habits, including bruxism. 2. Heavy smokers consuming more than 10 cigarettes per day. 3. Patients receiving radiotherapy or chemotherapy. 4. Long-term use of medications known to affect bone metabolism, such as corticosteroids. 5. Pregnant or breastfeeding women. 6. Insufficient interocclusal space for prosthetic rehabilitation. 7. Patients with metabolic or bone disorders affecting bone quality or density, including hyperparathyroidism and osteoporosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Stability Quotient (ISQ) | At implant placement (baseline), 3 weeks after implant placement, and 4 weeks after implant placement. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant Marginal Bone Loss | At implant placement (baseline) and one year after early loading. | 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 |
Countries
Syria
Contacts
STUDY_CHAIRIssam Alkhouri, DDS, Phd
Faculty of Dentistry, Damascus University, Damascus, Syria
PRINCIPAL_INVESTIGATORAwab Al-Midani, Master's Degree Candidate
Faculty of Dentistry, Damascus University, Damascus, Syria
Outcome results
None listed