| CTRI Number |
CTRI/2026/04/108521 [Registered on: 16/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Light Therapy to help Dental Implant Patients heal faster: A Study on Implant Stability and Bone Healing |
|
Scientific Title of Study
|
Comparative Evaluation of Photobiomodulation Therapy on Primary Dental Implant Stability and Biochemical Assessment of Osteocalcin levels in Peri-Implant Crevicular Fluid A Randomized Controlled Study |
| 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 Diksha Swaroop |
| Designation |
Postgraduate Student |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road Faridabad Haryana
Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road Faridabad Haryana
Faridabad
HARYANA
121004
India |
| Phone |
7585927240 |
| Fax |
|
| Email |
dikshaswaroop11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lipika Gopal |
| Designation |
Reader |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road Faridabad Haryana
Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road Faridabad Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9717546141 |
| Fax |
|
| Email |
lipika.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lipika Gopal |
| Designation |
Reader |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road Faridabad Haryana
Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road Faridabad Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9717546141 |
| Fax |
|
| Email |
lipika.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Diksha Swaroop |
| Address |
Department of Periodontology Room 8 Manav Rachna Dental College SDS MRIIRS Delhi Surajkund Road Faridabad |
| 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 Diksha Swaroop |
MANAV RACHNA DENTAL COLLEGE, SDS, MRIIRS |
Department of Periodontology Room 8 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road
Faridabad
HARYANA |
07585927240
dikshaswaroop11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College, Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partially edentulous systemically and periodontally healthy subjects |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dental implant placement without the application of photobiomodulation therapy |
Only dental implants will be placed and PBM will not be applied |
| Intervention |
Photobiomodulation |
Photobiomodulation will be applied at baseline that is immediately after implant placement after 24 hrs and after 1 week
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically and periodontally healthy individuals
Good compliance
Patient available for follow up visits
Patient willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Systemic diseases (e.g. Uncontrolled diabetes, osteoporosis )
Pregnant or lactating women
Smokers or tobacco users
Patient on medications influencing bone healing (Immunosuppressants, vitamin
D, calcium supplements)
Presence of active infection or pathology at the implant site
Poor oral hygiene or untreated periodontal disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There may or may not be any difference seen in implant primary stability and osteocalcin levels in peri implant crevicular fluid between implants treated with photobiomodulation therapy and implants that undergo normal healing without PBM |
Photobiomodulation applied post implant placement 24 hrs and at 1 week
ISQ values will be recorded at baseline and 3 months
Osteocalcin levels evaluated in PICF at baseline (1 week post implant placement along with healing abutment) and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
09/06/2026 |
| 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 study will evaluate the effect of photobiomodulation therapy on the primary stability of dental implants and on osteocalcin levels in peri-implant crevicular fluid in the two group i.e. Test group in which the Dental Implants placed in Periodontally Healthy Patients will be treated using with photobiomodulation therapy and Control group will receive the same but no PBM will be applied at 24 hrs and at one week. Photobiomodulation will be applied in the test group at baseline that is immediately after implant placement, after 24 hrs and after 1 week Implant stability will be checked by Resonance Frequency Analysis at baseline that is 1 week post implant placement and healing abutment and at 3 months. To evaluate osteocalcin levels in Peri implant crevicular fluid, PICF will be collected after 1 week of placing implant and healing abutment together, to check osteocalcin levels at baseline (1 week post implant placement and healing abutment ) and at 3 months with ELISA
|