| CTRI Number |
CTRI/2025/12/098543 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Photobiomodulation therapy] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect Photobiomodulation therapy adjunct to implant placement vs standard implant placement on implant stability, osteocalcin and on crestal bone level |
|
Scientific Title of Study
|
Comparative evaluation of implant stability, osteocalcin and crestal bone level with and without photobiomodulation: a randomised 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 |
Vrushali More |
| Designation |
II MDS student periodotology |
| Affiliation |
bharati vidyapeeth deemed to be university dental college and hospital, sangli. |
| Address |
Bharati Vidyapeeth Deemed university Girls hostel number4 ,Sangli Miraj Kupwad, Maharashtra 41616.
Sangli
MAHARASHTRA
416416
India |
| Phone |
09373430986 |
| Fax |
|
| Email |
vrushalimore6107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi kamble |
| Designation |
Associate professor |
| Affiliation |
bharati vidyapeeth deemed to be university dental college and hospital, sangli. |
| Address |
Miraj
Sangli
MAHARASHTRA
416416
India |
| Phone |
7756811987 |
| Fax |
|
| Email |
kamble.pallavi60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi kamble |
| Designation |
Associate professor |
| Affiliation |
bharati vidyapeeth deemed to be university dental college and hospital, sangli. |
| Address |
Miraj
Sangli
MAHARASHTRA
416416
India |
| Phone |
7756811987 |
| Fax |
|
| Email |
kamble.pallavi60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth dental college and hospital , Sangli. |
|
|
Primary Sponsor
|
| Name |
Dr Vrushali More |
| Address |
Bharati vidyapeeth deeemed to be university girls hostel number-4,sangli 416416 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vrushali More |
Department of periodontology |
Bharati Vidyapeeth Deemed to be university, walnesswadi Sangli Miraj Kupwad, Maharashtra 41616.
Sangli
MAHARASHTRA |
09373430986
vrushalimore6107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BVDU Medical College and hospital , Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
partially edentulous patients who are suitable for dental implant procedure |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Photobiomodulation therapy |
photobiomodulation therapy with combo-coherence mode will be given to test group |
| Comparator Agent |
without photobiomodulation |
no photobiomodulation therapy will be given to control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
1. Patients of age 18 years and above
2. Signed informed consent obtained by the patient.
3. Patients with missing tooth in maxilla/mandible
4. Have at least one tooth, both single or multi-rooted, indicated to extraction due to crack, fracture, or perforation and the possibility of placement of a dental implant
5. Adequate bone dimensions for implant placement without the need for guided bone regeneration procedures
6. Post-extraction alveolar sockets with at least three remaining walls
7. Good general health, which allows for dental implant surgery
|
|
| ExclusionCriteria |
| Details |
2. Systemic disease
3. Chronic smokers
4. Pregnant woman
5. Patients having poor oral hygiene
6. Parafunctional habits
7. Supra eruption of opposing teeth.
8. History of radiation therapy in head and neck region
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
implant stability
osteocalcin
crestal bone level |
implant stability
osteocalcin
crestal bone level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
peri-implant soft tissue health
co relation of clinical and radiographic parameters |
3month
6month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2025 |
| 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="11"
Days="25" |
|
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 randomised clinical trial evaluate effect of photobiomodulation therapy on crestal bone level, implant stability and osteocalcin levels in PICF around endosseous implant . Photobiomodulation therapy stimulate healing reduce pain and inflammation without damaging tissue. Partially edentulous patents who are full filing inclusion criteria will be randomly allocated into test group(photobiomodulation) and control group (no photobiomodulation therapy). Implant placement will be performed by standard protocol. Implant stability will be measured using resonance frequency analysis , cresta bone level by using CBCT at 3months, 6 months. PICF will be collected at scheduled visits to quantify osteocalcin by using ELISA . This study aims to evaluated whether adjunctive application of photobiomodulation therapy on implant surface to improve implant stability, crestal bone loss and osteocalcin for bone formation . |