| CTRI Number |
CTRI/2026/03/105370 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Bone Levels Around Dental Implants With and Without Light Therapy Using 3D Scans |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF CRESTAL BONE LEVELS AROUND ENDOSSEOUS IMPLANTS WITH AND WITHOUT PHOTOBIOSTIMULATION: A CONE BEAM COMPUTED TOMOGRAPHY BASED RANDOMIZED 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 |
DR RAGHAVENDRA METRI |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research |
| Address |
NO 10 DEPARTMENT OF PERIODONTOLOGY MIDSR DENTAL COLLEGE LATUR
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9765798877 |
| Fax |
|
| Email |
drmetriraghu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ROHINI BHISE |
| Designation |
MDS I |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research |
| Address |
NO 10 DEPARTMENT OF PERIODONTOLOGY MIDSR DENTAL COLLEGE LATUR
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9158118232 |
| Fax |
|
| Email |
drrohinibhise@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAGHAVENDRA METRI |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
|
| Address |
NO 10 DEPARTMENT OF PERIODONTOLOGY MIDSR DENTAL COLLEGE LATUR
Latur
MAHARASHTRA
413512
India |
| Phone |
9765798877 |
| Fax |
|
| Email |
drmetriraghu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Dental Sciences and Research, Latur, Maharashtra, India 413 512 |
|
|
Primary Sponsor
|
| Name |
Dr Rohini Bhise |
| Address |
No. 10 Department of Periodontology MIDSR Dental College Latur, Maharashtra ,India 413512 |
| 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 ROHINI BHISE |
MIDSR Dental College, Latur. |
NO 10 DEPARTMENT OF PERIODONTOLOGY MIDSR DENTAL COLLEGE LATUR
Latur
MAHARASHTRA |
09158118232
drrohinibhise@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MIDSR DC Latur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Photobiostimulation Therapy |
Total duration of intervention is 2 weeks.Photobiostimulation Therapy will be delivered using a 940 nm diode laser in continuous wave mode with a calibrated output power of 100 mW.The buccal and palatal mucosa adjacent to the implant will be irradiated for 40 seconds per side.The total energy delivered will be 4 J per side, summing to 8 J per implant. Photobiostimulation will be repeated at 2-day intervals for 2 weeks postoperatively (Total 7 Sessions). |
| Comparator Agent |
Without Photobiostimulation Therapy |
Dental Implants are placed Without Photobiostimulation Therapy. Zero sessions of photobiomodulation therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age range 18-70 years
Single missing anterior or posterior tooth with an adequate width and height of edentulous space available for the placement of implant.
Systemically healthy patients ASA Grade I and II (American Society of Anesthesiology).
Healed alveolar ridge (at least 3 months after tooth extraction).
Adjacent tooth intact with aesthetically and functionally good restoration.
|
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions affecting bone metabolism, such as diabetes mellitus, osteoporosis, malignancy, renal or liver dysfunction, endocrine disorders, or those receiving bisphosphonate therapy.
Patients with severe parafunctional habits (e.g., bruxism).
Pregnant or lactating women.
Patients unable to maintain proper oral hygiene.
Presence of any pathologic condition in the area intended for implant placement.
Patients with tobacco/smoking habits, psychological disorders, or unrealistic expectations regarding treatment outcomes.
Patients undergoing or with a history of chemotherapy or radiotherapy.
Patients on medications known to alter bone metabolism.
Patients unwilling to provide informed consent to participate in the study
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peri-implant crestal bone levels - To evaluate changes in crestal bone levels around endosseous dental implants from baseline (immediately post-placement) to 3 months after prosthesis delivery, while accounting for physiologic bone remodelling expected in the first year of implant integration |
at baseline (immediately after implant placement) and at 6 month follow-up post-implant placement or 3 months post-prosthesis delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bucco-lingual dimensional changes of the peri-implant alveolar bone as measured by CBCT |
at baseline & six months following dental implant placement |
| Peri-implant bone density as measured by CBCT |
at baseline & six months following dental implant placement |
| Peri-implant Probing Depth |
at the time of prosthetic delivery & at the three-month follow-up |
| Modified Plaque Index |
2 weeks after placement of healing abutment before recording impression & at 3 months after prosthesis delivery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drrohinibhise@gmail.com].
- For how long will this data be available start date provided 16-03-2026 and end date provided 27-12-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Dental implants have become the gold standard for the rehabilitation of edentulous sites, owing to their high success rates and ability to restore both function and esthetics. However, early crestal bone remodelling remains a critical determinant of long-term implant stability. Loss of crestal bone compromises osseointegration, prosthetic longevity, and esthetic outcomes, making it a key parameter in implant research and clinical practice. Photobiostimulation (PBS), delivered via low-level laser or light-emitting diodes, has emerged as a promising adjunctive modality to enhance peri-implant healing. PBS operates through the absorption of red to near-infrared light (600-1000 nm) by mitochondrial chromophores, leading to increased ATP production, modulation of reactive oxygen species, and activation of transcription factors. These cellular events promote osteoblastic activity, angiogenesis, and soft tissue repair. Recent randomized controlled trials and systematic reviews have reported that photobiostimulation may improve implant stability, reduce crestal bone loss, and accelerate soft tissue healing. A systematic review and meta-analysis concluded that photobiostimulation significantly enhances implant stability and reduce crestal bone loss in healed sites. Similarly, randomized double-blind clinical studies demonstrated improved bone density and reduced inflammation around implants following photobiostimulation. Radiographic evaluation, particularly using cone beam computed tomography(CBCT), provides a three-dimensional and quantitative assessment of peri-implant bone changes. The studies employing CBCT have shown that photobiostimulation can positively influence crestal bone density after implant placement. Photobiostimulation enhances alveolar bone repair by reducing pain and inflammation, stimulating angiogenesis, and accelerating new bone matrix formation-supporting ridge height and thickness. While preliminary evidence supports photobiostimulation’s benefits, the scarcity of prospective clinical trials using CBCT leaves unanswered questions about its multidimensional effects on crestal bone levels, bucco-lingual dimensional stability, and bone density. This prospective, CBCT-controlled trial fills this critical evidence gap with comprehensive peri-implant bone assessments. Therefore, the purpose of this study is to comparatively evaluate the effect of photobiostimulation on peri-implant crestal bone levels, bucco-lingual dimensional stability, and peri-implant bone density around endosseous implants using CBCT. Specifically, radiographic changes will be assessed to determine differences between implants treated with photobiostimulation (intervention group) and those without photobiostimulation (control group).
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