| CTRI Number |
CTRI/2026/04/107712 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study on the Effect of Laser Therapy in Improving Bone Healing in Gum Disease |
|
Scientific Title of Study
|
Effect of Adjunctive Photobiomodulation Therapy on Sticky Bone in the Treatment of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial. |
| Trial Acronym |
NL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karan Ramanuj |
| Designation |
Post Graduate student |
| Affiliation |
College of Dental Science and Hospital, Amargadh |
| Address |
room no 5 department of periodontology College of Dental Science and Hospital, K.J mehta trust, Amargadh, Sihor, bhavnagar.
room no 5 department of periodontology College of dental science and hospital, K.J mehta trust, Amargadh, Sihor,
Bhavnagar, 364210
Bhavnagar
GUJARAT
364210
India |
| Phone |
8200170087 |
| Fax |
|
| Email |
drkaranramanuj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeeth Rai |
| Designation |
PG Guide and Professor |
| Affiliation |
College of dental science and hospital |
| Address |
room no 5 department of periodontology College of Dental Science and Hospital, K.J mehta trust, Amargadh, Sihor, bhavnagar.
room no 5 department of periodontology College of Dental Science and Hospital, K.J mehta trust, Amargadh, Sihor, bhavnagar.
Bhavnagar
GUJARAT
364210
India |
| Phone |
9011291375 |
| Fax |
|
| Email |
jeeth_rai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeeth Rai |
| Designation |
PG Guide and Professor |
| Affiliation |
College of dental science and hospital |
| Address |
room no 5 department of periodontology College of Dental Science and Hospital, K.J mehta trust, Amargadh, Sihor, bhavnagar.
room no 5 department of periodontology College of Dental Science and Hospital, K.J mehta trust, Amargadh, Sihor, bhavnagar.
Bhavnagar
GUJARAT
364210
India |
| Phone |
9011291375 |
| Fax |
|
| Email |
jeeth_rai@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Collage of dental science and hospital |
| Address |
Collage of dental science and hospital,K.J Mehta T.B trust, amargadh ,sihor,bhavnagar,gujarat
364210 Ind |
| 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 |
| Dr Karan Ramanuj |
CODS Amargadh Department of Periodontics division P IX-Perio |
room no 5 department of periodontology College of Dental Science and Hospital, K.J mehta trust, Amargadh, Sihor,
Bhavnagar Gujarat 364210 Bhavnagar GUJARAT 364210 India
Bhavnagar
GUJARAT |
8200170087
drkaranramanuj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparator agent |
The selected quadrant will be treated with sticky bone followed by placebo (with the laser handpiece positioned at the site for the required duration without activation.)
|
| Intervention |
intervention |
The contralateral quadrant will be treated with sticky bone in combination with photobiomodulation.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Probing pocket depth more then or equal to 4mm
Presence of at least two contralateral intrabony defects (combined two and three walls)
Patient willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Smokers/ tobacco chewers
3. Furcation defects.
4. History of any systemic diseases like severe hypertension, uncontrolled diabetes, cardiac disease, HIV, hepatitis, Bone metabolic disorders, radiation therapy, immunosuppressive therapy, malignancy, blood disorders.
5. Endodontic lesions, overhanging restorations and iatrogenic factors.
6. Medications known to affect the outcomes of periodontal therapy.
7. Patients who had undergone any surgical periodontal therapy in the preceding 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess clinical attachment level gain between the two groups.
|
base line ,3,6,9 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare probing pocket deapth.
2.to comapare healing out come
3. radiographic accesment
4. vas scale |
1.0,3,6,and 9 month
2.0 & 7 days
3.0 & 6 month
4. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/08/2026 |
| 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)
|
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
|
35-60 years aged patients reporting to the Department of Periodontology at
the College of Dental Science and hospital, Amargadh having chronic
periodontitis with infrabony defects having pocket depth more than 4 mm will
be considered as inclusion criteria for the study. A total of 20 patients and 40 sites will be
selected to
evaluate the impact of adjunctive photobiomodulation with
sticky bone on clinical parameter, radiographic bone regeneration, and
postoperative healing outcome. |