| CTRI Number |
CTRI/2025/07/090099 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Various tooth medicament filling material comparison |
|
Scientific Title of Study
|
Comparative evaluation of laser activated collagen and Light cure MTA as a novel pulpotomy agent: 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 |
Dr Kashyap B |
| Designation |
Student |
| Affiliation |
AME Dental College Raichur,Karnataka,India |
| Address |
Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR
Raichur KARNATAKA 584103 India |
| Phone |
9481682945 |
| Fax |
|
| Email |
kashyapkannanth@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Raghavendra Havale |
| Designation |
Head of the depar |
| Affiliation |
AME Dental College Raichur,Karnataka,India |
| Address |
Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR
Raichur KARNATAKA 584103 India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR PRAVEEN KUMAR N H |
| Designation |
Reader |
| Affiliation |
AME Dental College Raichur,Karnataka,India |
| Address |
Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR
Raichur KARNATAKA 584103 India |
| Phone |
9538623728 |
| Fax |
|
| Email |
drpraveennh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kashyap B |
| Address |
Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR - 584103 |
| 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 Kashyap B |
AME Dental College Raichur. |
Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR -584103 Raichur KARNATAKA |
9481682945
kashyapkannanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for AME denatl college |
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 |
| Comparator Agent |
Laser activated collagen |
It is given as pulpotomy agent and measured every 3 months for 1 year |
| Intervention |
Light cure MTA |
It is given as pulpotomy agent and measured every 3 months for 1 year |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
An age range of 4-8 years,Lower right/left first/ second primary molars with reversible pulpitis, Carious/mechanical pulp exposure, No clinical or radiographic sign of pulp pathoses, Deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically
|
|
| ExclusionCriteria |
| Details |
History of spontaneous and unprovoked pain, Mobility, Sensitive to percussion, Any sign of Presence of fistulae, external or internal root resorption, carious furcation involvement, and periapical lesion, Dystrophic calcification of the pulp
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical and radiographic success of Laser-Enhanced Collagen and Light-Cured MTA pulpotomy procedures at specified follow-up intervals. |
at 1 month, 3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
27/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After
the selection of participants, the procedure will begin with administration of
local anesthesia and the teeth will be isolated. The soft carious lesions will
be first excavated using a spoon excavator, followed by which access opening
will be performed using a high-speed bur with the aerator. Following the
initial drop into the pulp chamber, the tooth will be reassured by operative
diagnosis by analyzing the nature of the pulpal bleeding. Following the
Satisfactory operatory diagnosis, the treatment will be continued, the pulp
chamber will be completely deroofed, the coronal portion of the pulp will be removed with the intact untouched radicular pulp, and finally, irrigation will be done with
saline to remove the dentinal debris. A cotton pellet dipped with saline will
be placed over the root canal orifice to attain hemostasis, followed by which
Light cure MTA pulpotomy and Laser enhanced collagen-based pulpotomy will be
carried in their respective groups. After the pulpotomy procedures the tooth
will be restored with the Stainless steel crowns.
Follow
up will be done at 1 month, 3 month, 6 months and 12 months. At each time
period clinical (pain, tenderness to percussion, abscess, swelling, fistula,
and pathologic mobility) and radiographic analysis(radicular radiolucency,
internal and external root resorption, periodontal ligament space widening, and
furcation radiolucency) will be made. |