| CTRI Number |
CTRI/2024/08/071972 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing different types of materials for Pulpotomy in primary molar teeth in children. |
|
Scientific Title of Study
|
Comparative evaluation of pulpotomy using Mineral trioxide aggregate (MTA), Diode Laser and Er, Cr: YSGG Laser in primary molar teeth– A Randomized Controlled 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 Vishal |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
5th floor, Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences,
BSZ Marg, New Delhi.
Central
DELHI
110002
India |
| Phone |
9599447498 |
| Fax |
|
| Email |
Vishalbharti110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyanendra kumar |
| Designation |
Professor(SAG) |
| Affiliation |
Maulana Azad Institute of Dental Sciences New Delhi |
| Address |
Post Graduate clinic, 5th floor, Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences,
BSZ Marg, New Delhi.
Central
DELHI
110002
India |
| Phone |
9654700978 |
| Fax |
|
| Email |
gyanendrasaroj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Institute of Dental Sciences New Delhi |
| Address |
Post Graduate clinic, 5th floor, Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences,
BSZ Marg, New Delhi.
Central
DELHI
110002
India |
| Phone |
09599447498 |
| Fax |
|
| Email |
Vishalbharti110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences,
New Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 Vishal |
Maulana Azad Institute Of Dental Sciences |
Post Graduate clinic,
5th floor, Department of
Pediatric and
Preventive Dentistry
Central
DELHI
Central
DELHI |
09599447498
Vishalbharti110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Institute of Dental Sciences |
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 |
Diode Laser for pulpotomy |
Use of Diode Laser for pulpotomy in primary molars being
evaluated for 9 months in every
patient. |
| Intervention |
Er,Cr:YSGG laser for pulpotomy |
Use of Er,Cr:YSGG laser for pulpotomy in primary molars being
evaluated for 9 months in every
patient. |
| Comparator Agent |
Mineral Trioxide Aggregate (MTA) for pulpotomy |
Use of Mineral Trioxide Aggregate (MTA) for pulpotomy in primary molars being evaluated for 9 months in every patient |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age group of 5 to 8 years.
2. Primary molars in which coronal portion of pulp is involved (indicated for pulpotomy)
3. Parents/Children willing to give informed consent/informed assent respectively.
4. Apparently healthy Children without systemic or metabolic disorders.
|
|
| ExclusionCriteria |
| Details |
1. Children with irreversible pulpitis, chronic pulpalgia, and abnormal sensitivity of tooth to heat and cold.
2. Tenderness to percussion or palpation because of pulpal disease.
3. Inter radicular or periapical bone destruction as seen on radiographs.
4. Children with special health care needs.
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical success of pulpotomy on the basis of:
• Normal appearance of gingiva.
• Absence of clinical signs and symptoms of pulpal inflammation such as spontaneous pain, tenderness, swelling, fistula, abscess formation.
• Absence of mobility in the tooth.
2. Radiographic success of pulpotomy on the basis of:
• Absence of any periapical or inter radicular radiolucencies.
• The integrity of lamina dura.
• Absence of pathologic root resorption.
|
baseline (T0), 3 month (T1), 6 months (T2) and 9
months (T3)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Er,Cr:YSGG laser and Diode Laser show comparable
clinical and radiographic sucsess as Mineral Trioxide Aggregate (MTA) in Pulpotomy in primary molars. |
baseline (T0), 3 month (T1), 6 months (T2) and 9
months (T3) |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| Date of Study Completion (India) |
02/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
This study is a randomized, single-blinded, single-centre trial comparing the clinical and radiographic success of Pulpotomy using Mineral Trioxide Aggregate (MTA), Diode Laser and Er,Cr:YSGG Laser in primary molar teeth– A Randomized Controlled Trial in children in the age group of 5-8 years in the Department of Pediatric and Preventive Dentistry, MAIDS. The primary outcome will depict the clinical and radiographic success of Pulpotomy and the secondary outcome will compare the 3 types of Pulpotomy treatment. All patients will be evaluated at baseline, 3, 6 and 9 months. The need for this study arises from the of comprehensive data on their respective clinical performances in vivo. |