CTRI Number |
CTRI/2025/05/087133 [Registered on: 20/05/2025] Trial Registered Prospectively |
Last Modified On: |
19/05/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparing Laser and Conventional Pulpotomy Treatments in Patients with Tooth Pain |
Scientific Title of Study
|
Comparative Evaluation of Healing Outcomes of LASER and Conventional Pulpotomy in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
MGM/DCH/IEC/77/1/25 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Divya Naik |
Designation |
Reader |
Affiliation |
MGM Dental College and Hospital Kamothe Navi Mumbai |
Address |
201 Department of Conservative Dentistry and endodontics MGM Dental college and Hospital kamothe Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra
Raigarh MAHARASHTRA 410209 India |
Phone |
9967826262 |
Fax |
|
Email |
drdolly02@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Divya Naik |
Designation |
Reader |
Affiliation |
MGM Dental College and Hospital Kamothe Navi Mumbai |
Address |
201 Department of Conservative Dentistry and endodontics MGM Dental college and Hospital kamothe Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra
Raigarh MAHARASHTRA 410209 India |
Phone |
9967826262 |
Fax |
|
Email |
drdolly02@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Divya Naik |
Designation |
Reader |
Affiliation |
MGM Dental College and Hospital Kamothe Navi Mumbai |
Address |
201 Department of Conservative Dentistry and endodontics MGM Dental college and Hospital kamothe Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra
Raigarh MAHARASHTRA 410209 India |
Phone |
9967826262 |
Fax |
|
Email |
drdolly02@gmail.com |
|
Source of Monetary or Material Support
|
MGM Dental College and Hospital Kamothe Navi mumbai 410209 Maharashtra India |
|
Primary Sponsor
|
Name |
Dr Divya Naik |
Address |
MGM Dental College and Hospital Kamothe Navi Mumbai 410209 |
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 Divya Naik |
MGM Dental College and Hospital |
201 Department of Conservative Dentistry and Endodontics Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra 410209 India Raigarh MAHARASHTRA |
9967826262
drdolly02@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IECMGMDCH |
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 |
Laser Pulpotomy |
The device used will be a diode laser, Epic X, with a wavelength of 940nm. The procedure will be performed under local anesthesia and rubber dam isolation. The laser energy will be delivered through a 200µm optical fiber tip in a non-contact mode for two to three seconds at intervals of thirty seconds. Laser application will continue until the pulp tissue is completely ablated and hemostasis is achieved.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Participants who accept the study goals and requirements and are willing to participate in the study
All Participants are in good health, based on their written health histories and oral interviews
Participants range in age from 18 to 50 yrs old with both male and female Participants
Participants with moderate to severe pain involving one tooth
All vital teeth with irreversible pulpitis whether associated with or without apical periodontitis
Participant with PAI index score of 1
Thermal and electric pulp tests yielded a positive result
Only teeth with favorable conditions for rubber dam application are considered
Teeth with fully developed apex
Teeth with healthy periodontium with periodontal probing depth less than 3mm
Permanent human teeth
Intact teeth with no cracks or defects
|
|
ExclusionCriteria |
Details |
Participants who will not accept the study freely
Participants who do not provide authorization for participation
Participants below 18 years and above 50 years of age
Participants who have taken antibiotics in past 1 month
Participants who have taken analgesic within past 48 hours
Pregnant women and nursing mothers
Participants with non-vital teeth
Participants with acute or chronic dentoalveolar abscess or cellulitis
Participants whose tooth has been accessed previously or endodontically treated
Participants with inflamed pulp in which bleeding could not be controlled within 10 minutes
Participants who have taken medications which in the opinion of the investigator could interfere with the conduct of the study eg corticosteroids antibiotics and analgesics in the past month
Participants with known systemic disorders or immunocompromised conditions eg diabetes AIDS
Participants who have a current or recent history of alcohol or other substance abuse
Participants with PAI index score
Participants with an intraoral and extraoral sinus tract
Teeth with aggressive periodontitis and grade III mobility periodontal probing depth greater than 3mm
Severe labially or lingually malposition teeth in which clinical access will be difficult
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Evaluate the healing outcomes of laser pulpotomy compared with conventional pulpotomy in the management of patients with symptomatic irreversible pulpitis.
|
1 year follow up
|
|
Secondary Outcome
|
Outcome |
TimePoints |
outcome of radiographic success will be classified using a Orstavik’s Periapical Index score (PAI). teeth with normal contour or width of PDL will be deliberated as success, and teeth with periapical radiolucency will be reported as failure.
|
1 year followup |
the preoperative and post-operative pain levels will be recorded by using a visual analogue scale (VAS).
|
The post operative pain levels will be recorded at intervals of 6 hours, 24 hours, and 7 days after the initial visit.
|
|
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 3 |
Date of First Enrollment (India)
|
01/07/2025 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
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 - 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 Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drdolly02@gmail.com].
- For how long will this data be available start date provided 01-07-2027 and end date provided 01-07-2032?
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
|
Brief Summary
|
This randomized controlled trial investigates the comparative
healing outcomes of diode laser pulpotomy versus conventional pulpotomy in
mature permanent teeth diagnosed with symptomatic irreversible pulpitis. As a
vital pulp therapy (VPT) technique, pulpotomy has gained traction as a
minimally invasive alternative to root canal therapy (RCT), aiming to preserve
pulpal vitality while reducing procedural complexity, treatment costs, and
patient discomfort.
The diode
laser offers unique benefits, including precise tissue ablation, effective
hemostasis, and antibacterial properties, potentially minimizing bleeding,
bacterial contamination, and mechanical damage during the procedure.
Conventional pulpotomy, on the other hand, relies on well-established
protocols, including the use of sodium hypochlorite for hemostasis and
materials like mineral trioxide aggregate (MTA) for pulp sealing and healing.
Key
objectives of the study include assessing the clinical and radiographic success
rates of both techniques, evaluating postoperative pain levels, and analyzing
healing dynamics over time. Additionally, the study examines whether diode
laser pulpotomy offers a more efficient and predictable approach to managing
irreversible pulpitis or if conventional pulpotomy remains the standard of
care.
The findings
aim to provide clarity on the optimal approach for treating symptomatic
irreversible pulpitis in mature permanent teeth, potentially influencing
clinical guidelines, improving patient outcomes, and expanding treatment
options beyond traditional root canal therapy.
|