| CTRI Number |
CTRI/2026/03/105724 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of laser and normal saline to arrest bleeding for treating painful adult permanent teeth |
|
Scientific Title of Study
|
Evaluation of clinical success rates of laser assisted MTA pulpotomy in mature permanent teeth with reversible pulpitis - a randomized control 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 |
Jesanth Joel R |
| Designation |
Postgraduate student |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Room No. 6, CSI College of Dental sciences and Research, Department of conservative dentistry and endodontics, 129 CMH Compound, East Veli Street,
Madurai
TAMIL NADU
625001
India |
| Phone |
8248494531 |
| Fax |
|
| Email |
jesanthjoel96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of Conservative dentistry and endodontics |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Room No. 6, CSI College of Dental sciences and Research, Department of conservative dentistry and endodontics, 129 CMH Compound, East Veli Street,
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Swathi Priyadharshini |
| Designation |
Reader |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Room No. 6, CSI College of Dental sciences and Research, Department of conservative dentistry and endodontics, 129 CMH Compound, East Veli Street,
Madurai
TAMIL NADU
625001
India |
| Phone |
9994278283 |
| Fax |
|
| Email |
dr.swathipriyadharshini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr R Jesanth Joel |
| Address |
Room no 6 , Department of conservative dentistry and endodontics ,CSI
College of dental sciences and research , 129 CMH Compound ,East
Veli Street ,Madurai 625001 |
| 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 R Jesanth Joel |
CSI College of dental sciences and research |
Room No. 6, CSI College of Dental sciences and Research, Department of conservative dentistry and endodontics, 129 CMH Compound, East Veli Street,
Madurai
TAMIL NADU |
8248494531
jesanthjoel96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Institutional Review Board - CSI College of dental science and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MEDICAL DEVICE - iLase - Diode Laser system
Manufacturing company - BIOLASE Inc, USA
|
The LASER is activated at a wavelength of 940nm and 0.5W power for 4 seconds on each root canal oritice using a 200 - micron fiber tip until bleeding is arrested. The working time for each patients is 40 - 60 seconds |
| Comparator Agent |
Normal saline 0.9% W/V
manufacturing company - IHL LIFESCIENCES PVT. LTD. Khargone (M.P.) India |
a sterile cotton pellet is dipped into the normal saline and placed over the exposed pulp chamber directly for 2 - 10 minutes until the bleeding is arrested. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with posterior teeth having spontaneous sensitivity or sensitivity to heat/cold
Teeth with reversible pulpitis, that shows immediate sensitive response which subsides on withdrawal of stimulus on cold test.
Teeth with no PDL widening or loss of lamina dura on radiographs.
Teeth that shows no tenderness to percussion
|
|
| ExclusionCriteria |
| Details |
Teeth where pulpal bleeding prolonging more than 10 mins.
Teeth with lingering response on cold test.
Patient who are not willing for pulpotomy.
Patients having TMJ disorders, calcified canals or periodontally compromised tooth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical success rates of LASER assisted pulpotomy |
3 months, 6 months and 1 year after pulpotomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the survival of toot after pulpotomy in both the groups. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/03/2026 |
| 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="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
|
The present study aims to evaluate the clinical success rates such as absence of pain and no abnormalities in intraoral periapical radiographs following MTA pulpotomy using iLase Biolase Laser and normal saline for achieving hemostasis. The present study evaluates the clinical success rates at 3, 6 and 12 months following pulpotomy and the tooth survival after 1 year of pulpotomy in both the groups |