| CTRI Number |
CTRI/2026/03/105493 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Evaluate Clinical And Radiographic Effect Of UV Irradiated Sandblasted Large Grit And Acid Etched Surface Implant on Implant Stability And Marginal Bone Loss In Edentulous Maxillary Posterior Region |
|
Scientific Title of Study
|
Clinical Effect Of UV Irradiated Sandblasted Large Grit And Acid Etched Surface Implant On Implant Stability And Marginal Bone Loss In The Maxillary Posterior Region A Parallel Randomised Double Blind Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshan Khairnar |
| Designation |
Post Graduate Student |
| Affiliation |
S. C. B. Dental College And Hospital, Cuttack , Orissa , India |
| Address |
Department Of Periodontics And Oral Implantology, S. C. B. Dental College And Hospital Manglabagh Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9284538284 |
| Fax |
|
| Email |
darshankhairnar210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subash Chandra Raj |
| Designation |
Professor & HOD |
| Affiliation |
S. C. B. Dental College And Hospital Cuttack Orissa, India |
| Address |
Department Of Periodontics And Oral Implantology 3rd Floor S.C.B. Dental College And Hospital Cuttack, Orissa , India
Cuttack
ORISSA
753007
India |
| Phone |
9437008298 |
| Fax |
|
| Email |
drsubash007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Darshan Khairnar |
| Designation |
Post Graduate Student |
| Affiliation |
S. C. B. Dental College And Hospital, Cuttack, Orissa, India |
| Address |
Department Of Periodontics And Oral Implantology, S. C. B. Dental college And Hospital Manglabagh Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9284538284 |
| Fax |
|
| Email |
darshankhairnar210@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics and oral implantology S. C. B. Dental College And Hospital Cuttack Odisha |
|
|
Primary Sponsor
|
| Name |
Darshan Khairnar |
| Address |
Department Of Periodontics And Oral Implantology 3rd Floor S. C.B. Dental College And Hospital |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Darshan Khairnar |
S.C.B. Dental College And Hospital Cuttack |
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY 3RD FLOOR S.C.B. DENTAL COLLLEGE AND HOSPITAL CUTTACK
Cuttack
ORISSA |
9284538284
darshankhairnar210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC),S.C.B. DENTAL COLLEGE AND HOSPITAL,ODISHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
non uv treated |
After evaluation of pretreatment records and anatomical landmarks, patients will be prepared for implant placement under aseptic conditions using povidone iodine and 0.2% chlorhexidine rinse. Local anesthesia will be administered using 2% lignocaine with adrenaline. A crestal incision will be made, and a full-thickness mucoperiosteal flap will be elevated. The osteotomy site will be prepared using sequential drilling with copious saline irrigation under prosthetic guidance and surgical stent placement.
The implant will be placed aseptically using a torque ratchet, and primary stability will be confirmed. The flap will be repositioned and sutured using 3-0 silk sutures. In the control group, non uv treated implants will be placed. |
| Intervention |
uv treated group |
• After evaluation of pretreatment records and anatomical landmarks, patients will be prepared for implant placement under aseptic conditions using povidone iodine and 0.2% chlorhexidine rinse. Local anesthesia will be administered using 2% lignocaine with adrenaline. A crestal incision will be made, and a full-thickness mucoperiosteal flap will be elevated. The osteotomy site will be prepared using sequential drilling with copious saline irrigation under prosthetic guidance and surgical stent placement.
The implant will be placed aseptically using a torque ratchet, and primary stability will be confirmed. The flap will be repositioned and sutured using 3-0 silk sutures. In the test group, implants will be irradiated with UV light for 15 minutes before placement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Good oral hygiene and suitability for implant placement.
2.Sufficient bone height and width to receive the implant.
3.Edentulous area in the maxillary posterior region.
4.Healed extraction sockets with a history of extraction minimum 6 months ago.
5.Systemically healthy patient.
6.Patients willing to and fully capable of complying with the study protocol
|
|
| ExclusionCriteria |
| Details |
1.Patients who are not cooperating and with systemic co-morbidities that are likely to affect the study outcome (uncontrolled diabetes mellitus, immunocompromised patients, psychological problems, radiotherapy of head and neck region within the past 24 months).
2.Severe periodontal problems.
3.Conditions requiring bone graft.
4.Chronic alcoholism, and smoking.
5.When bone or soft tissue regeneration was needed to enhance implant stability or esthetics.
6.Patients under medication which are likely to affect the treatment outcome.
7.Presence of any parafunctional habits.
8.Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical effect of photofunctionalization on implant stability in the maxillary posterior region. |
baseline,4 weeks and 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the radiographic effect of UV irradiated SLA surface implant on marginal bone loss in the maxillary posterior region |
baseline,4 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized double-blinded clinical trial aims to evaluate the effect of ultraviolet (UV) photofunctionalization of sandblasted large-grit acid-etched (SLA) surface implants on implant stability and marginal bone loss in the posterior maxillary region. Biological aging of titanium implants due to hydrocarbon contamination reduces surface wettability and cellular response, which may compromise early osseointegration. UV photofunctionalization reverses this aging by increasing surface hydrophilicity and biological activity. Seventy systemically healthy patients with healed edentulous posterior maxillary sites will be randomly allocated into two groups: a test group receiving UV-irradiated implants and a control group receiving non-irradiated implants. Implant stability will be assessed using resonance frequency analysis at placement, 4 weeks, and 4 months postoperatively. Marginal bone loss will be evaluated using standardized periapical radiographs at baseline, 4 months, and 1 year. The study is designed to determine whether UV photofunctionalization enhances early implant stability and reduces marginal bone loss compared to conventional implants, thereby supporting its clinical relevance in improving osseointegration outcomes in the posterior maxilla. |