| CTRI Number |
CTRI/2026/02/104067 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision and evaluation of peri implant soft and hard tissue healing in dental implants with and without photofunctionalisation in maxillary arch: A randomized controlled trial.
________________________________________ |
|
Scientific Title of Study
|
Comparative evaluation of peri implant soft and hard tissue healing in dental implants with and without photofunctionalisation in maxillary arch: A randomized controlled 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 |
Dr Harshal Lohe |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre , Nagpur |
| Address |
104 Department of Periodontics and Implantology , Ranjeet Deshmukh Dental College and Research Centre , Digdoh Hills , Hingna Road, Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8007631990 |
| Fax |
|
| Email |
harshallohe1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Dean, HOD, Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre , Nagpur |
| Address |
104 Department of Periodontics and Implantology , Ranjeet Deshmukh Dental College and Research Centre , Digdoh Hills , Hingna Road, Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Dean, HOD, Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre , Nagpur |
| Address |
104 Department of Periodontics and Implantology , Ranjeet Deshmukh Dental College and Research Centre , Digdoh Hills , Hingna Road, Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
harshallohe1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Nagpur Maharashtra India 440019 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| 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 ABHAY KOLTE |
Ranjeet Deshmukh Dental College and Research Centre |
104 Department of Periodontics and Implantology Digdoh hills hingna road Nagpur
Nagpur
MAHARASHTRA |
9011071467
drabhaypkolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ranjeet Deshmukh Dental College and Research Centre Nagpur 440019 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant with photofunctionalisation |
To evaluate and compare peri-implant soft and hard tissue healing in dental implants placed with photofunctionalisation in the maxillary arch. |
| Comparator Agent |
Implant without photofunctionalisation |
To evaluate and compare peri-implant soft and hard tissue healing in dental implants placed without photofunctionalisation in the maxillary arch |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with edentulous sites in the maxillary arch requiring dental implant placement
Systemically healthy patients
Patients aged more than or equal to 18 year of age
Adequate bone volume in the maxillary arch
Good oral hygiene
Patients willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Smokers
Systemic diseases affecting bone metabolism
Pregnant or lactating females
Patients on long-term steroid or bisphosphonate therapy
Poor oral hygiene |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare peri-implant soft and hard tissue healing in dental implants placed with and without photofunctionalisation in the maxillary arch. |
Clinical soft tissue measurements will be recorded at baseline 3 months and 9 months except for the Landrys Healing Index which will be recorded at baseline 7 days and 14 days post operatively while the hard tissue measurements will be carried out at baseline 3 months and 9 months of implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate peri implant soft tissue healing using Landrys Healing index and Pink Esthetic score in photofunctionalised and non photofunctionalised dental implants
To compare peri implant soft tissue healing using Landrys Healing index and Pink Esthetic score in photofunctionalised and non photofunctionalised dental implants
To evaluate peri implant hard tissue healing at baseline three and nine months of implant placement by recording Resonance Frequency Analysis ISQ values crestal bone height bone density first bone implant contact BIC in photofunctionalised and non photofunctionalised dental implants
To compare peri implant hard tissue healing at baseline three and nine months of implant placement by recording Resonance Frequency Analysis ISQ values crestal bone height bone density first bone implant contact BIC in photofunctionalised and non photofunctionalised dental implants
|
Clinical soft tissue measurements will be recorded at baseline 3 months and 9 months except for the Landrys Healing Index which will be recorded at baseline 7 days and 14 days post operatively while the hard tissue measurements will be carried out at baseline 3 months and 9 months of implant placement |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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="6"
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 study is a randomized controlled clinical trial designed to comparatively evaluate peri-implant soft and hard tissue healing in dental implants placed with and without photofunctionalisation in the maxillary arch.
Photofunctionalisation is a surface activation technique in which titanium implants are exposed to ultraviolet light prior to placement. This process removes hydrocarbon contamination from the implant surface, restores hydrophilicity, enhances bioactivity, and promotes improved cellular attachment and osseointegration.
The primary aim of the study is to determine whether photofunctionalised implants show superior peri-implant soft tissue healing and hard tissue outcomes compared to non-photofunctionalised implants.
A total of 42 implant sites ,21 in the test group and 21 in the control group will be included. The test group implants will undergo UV photofunctionalisation for 15 minutes before placement, while the control group will receive conventional implants.
Soft tissue parameters will be evaluated using Landry’s Healing Index,Pink Esthetic Score,Plaque index and bleeding index,Probing depth and gingival thickness,Patient satisfaction i.e VAS questionnaire.
Hard tissue parameters will be assessed using Implant stability i.e ISQ values using RFA,Crestal bone height,Bone density,Bone-implant contact via CBCT.
Follow-up assessments will be conducted at baseline, 3 months, and 9 months with early healing index at 7 and 14 days. Statistical analysis will be performed using SPSS, with significance set at p less than 0.05.
The study duration is 18 months, and the results aim to provide clinical evidence regarding the effectiveness of photofunctionalisation in improving peri-implant tissue healing and overall implant success in the maxillary arch. |