UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059615 |
|---|---|
| Receipt number | R000068194 |
| Scientific Title | Comparative Evaluation of the Effect of UV Photofunctionalization and i-PRF Biofunctionalization on Osseointegration of Dental Implants: A Clinical and Radiographic Study |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/11/01 16:24:55 |
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Basic information
Public title
Comparative Evaluation of the Effect of UV Photofunctionalization and i-PRF Biofunctionalization on Osseointegration of Dental Implants: A Clinical and Radiographic Study
Acronym
Comparative Evaluation of the Effect of UV Photofunctionalization and i-PRF Biofunctionalization on Osseointegration of Dental Implants: A Clinical and Radiographic Study
Scientific Title
Comparative Evaluation of the Effect of UV Photofunctionalization and i-PRF Biofunctionalization on Osseointegration of Dental Implants: A Clinical and Radiographic Study
Scientific Title:Acronym
Comparative Evaluation of the Effect of UV Photofunctionalization and i-PRF Biofunctionalization on Osseointegration of Dental Implants: A Clinical and Radiographic Study
Region
| Asia(except Japan) |
Condition
Condition
Dental implants have become a reliable solution for restoring missing teeth, with long-term success largely dependent on achieving and maintaining osseointegration. Despite the high success rates reported, implant failures are still observed, commonly due to inadequate osseointegration or peri-implant infections. To improve outcomes, various surface modification strategies have been developed. UV treatment enhances protein adsorption, osteoblast attachment, and bone formation, thereby accelerating and improving osseointegration. On the other hand, biological approaches such as injectable platelet-rich fibrin (i-PRF) provide a biofunctionalization method that delivers autologous growth factors, including platelet-derived growth factor and vascular endothelial growth factor, which promote angiogenesis and osteogenesis.
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate and compare effects of UV photofunctionalization and iPRF biofunctionalization on implant osseointegration using clinical and radiographic parameters.
Basic objectives2
Others
Basic objectives -Others
This study aims to evaluate and compare effects of UV photofunctionalization and iPRF biofunctionalization on implant osseointegration using clinical and radiographic parameters for dental implant placement.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate clinical parameters such as Implant Stability Quotient in the 2 experimental groups.
Key secondary outcomes
To evaluate radiographic parameters such as Bone Quality and Peri-implant Marginal Bone loss, Pink esthetic score and success and survival rate in the 2 experimental groups.
To compare the data from the 2 groups and determine which functionalization method, (UV photofunctionalization or i-PRF biofunctionalization) provides superior osseointegration and overall implant success.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
UV PHOTOFUNCTIONALISATION TO ENHANCE OSSEOINTEGRATION FOR DENTAL IMPLANT PLACEMENT
Interventions/Control_2
i-PRF BIOFUNCTIONALISATION TO ENHANCE OSSEOINTEGRATION FOR DENTAL IMPLANT PLACEMENT
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects more than 18 years
2. Able to provide consent
3. Presence of healthy periodontium in adjacent teeth
4. Presence of D2 or D3 quality of bone
5. Minimum 1.5 mm bone must remain between dental implant and neighboring teeth as well as on facial side, and 0.5 mm bone must remain between implant and palatal side
Key exclusion criteria
1. Systemic diseases or metabolic disorders if any which may impact study, pregnant and lactating women.
2. Current smoker or quitted smoking <1 year ago
3. Parafunctional activities
4. Uncontrolled periodontal disease, caries, or clinical or radiographic signs of infection within two adjacent teeth
5. Current chemotherapy/radiotherapy or drugs that interfere with study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | AJAY |
| Middle name | |
| Last name | P |
Organization
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Division name
DEPARTMENT OF PERIODONTICS AND IMPLANT DENTISTRY
Zip code
625001
Address
129,EAST VELI STREET,MADURAI,TAMILNADU,INDIA
TEL
+916380099580
drajaypraba05@gmail.com
Public contact
Name of contact person
| 1st name | AJAY |
| Middle name | |
| Last name | P |
Organization
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Division name
DEPARTMENT OF PERIODONTICS AND IMPLANT DENTISTRY
Zip code
625001
Address
129,EAST VELI STREET,MADURAI,TAMILNADU,INDIA
TEL
+916380099580
Homepage URL
drajaypraba05@gmail.com
Sponsor or person
Institute
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Institute
Department
Personal name
DR.V.R.BALAJI
Funding Source
Organization
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Address
129, EAST VELI STREET, MADURAI, TAMILNADU
Tel
0452-2321709
csidentalethicalcommittee@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068194
