| CTRI Number |
CTRI/2018/06/014414 [Registered on: 05/06/2018] Trial Registered Prospectively |
| Last Modified On: |
05/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Pulpotomy in primary teeth |
|
Scientific Title of Study
|
Clinical And Radiographic
Evaluation of Pulpotomy using MTA, Biodentin and Er.Cr:YSGG Laser – A Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RAMANANDVIGNESH |
| Designation |
post graduate - MDS |
| Affiliation |
Maulana azad institute of dental sciences |
| Address |
5th floor, Dept. of pedodontics and preventive dentistry, MAIDS, MAMC campus, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9870144893 |
| Fax |
|
| Email |
ramanand.vignesh92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JATINDER KAUR DHILLON |
| Designation |
Assistant professor |
| Affiliation |
Maulana azad institute of dental sciences |
| Address |
5th floor, Dept. of pedodontics and preventive dentistry, MAIDS, MAMC campus, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9560784003 |
| Fax |
|
| Email |
dr.jatinderdhillon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RAMANANDVIGNESH |
| Designation |
POST GRADUATE |
| Affiliation |
Maulana azad institute of dental sciences |
| Address |
5th floor, Dept. of pedodontics and preventive dentistry, MAIDS, MAMC campus, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9870144893 |
| Fax |
|
| Email |
ramanand.vignesh92@gmail.com |
|
|
Source of Monetary or Material Support
|
| 5th floor, department of pediatric dentistry, Maulana Azad institute of dental sciences, MAMC CAMPUS,new delhi-110002 |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [] |
|
|
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 RAMANANDVIGNESH |
maulana azad institute of dental sciences |
5th floor,OPD clinic,MAIDS, MAMC CAMPUS
New Delhi
DELHI |
9870144893
ramanand.vignesh92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
normal healthy person with deep dental carious lesion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MTA, Erbium,Chromium:Yttrium Scandium Gallium Garnet LASER AND BIODENTIN |
CLINICAL AND RADIOGRAPHIC EVALUATION OF PULPOTOMY BY COMPARING MTA, Erbium,Chromium:Yttrium Scandium Gallium Garnet LASER AND BIODENTIN IN PRIMARY TEETH – an In Vivo Study for 1 year including follow up |
| Intervention |
Pulpotomy in primary teeth |
PULPOTOMY BY USING MTA for 1 year including follow up
PULPOTOMY BY USING Erbium,Chromium:Yttrium Scandium Gallium Garnet LASER for 1 year including follow up
PULPOTOMY BY USING BIODENTIN IN PRIMARY TEETH for 1 year including follow up |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Deep carious lesion in primary molars.
2. No history of spontaneous pain.
3. No clinical and radiographic evidence of inflamed pulp and degeneration such as uncontrolled bleeding.
4. No swelling or sinus tract.
5. No inter radicular or periapical bone destruction.
6. Positive parental informed consent.
7. No underlying systemic or metabolic disorders who may lead to loss of follow up visits.
|
|
| ExclusionCriteria |
| Details |
1. Excessive bleeding from pulp chamber.
2. Any sign of pulpal degeneration.
3. History of spontaneous pain.
4. Swelling or sinus tract present.
5. Inter radicular or periapical bone destruction as seen on radiographs.
6. Children with special health care needs who may not be able to visit or follow up.
|
|
|
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 |
1. No history of spontaneous pain.
2. No clinical and radiographic evidence of inflamed pulp and degeneration such as uncontrolled bleeding.
3. No swelling or sinus tract.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no interradicular bone destruction |
6 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
07/06/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This aim of this study to evaluate clinical and radiographic success of pulpotomy by using MTA, Er, Cr: YSGG LASER and Biodentin in primary teeth. There are various materials used for the pulpotomy. MTA, Er.Cr;YSGG laser, Biodentine laser are the recent materials can be used for the pulpotomy.MTA has demonstrated the ability to induce hard-tissue formation in pulpal tissues, and it promotes rapid cell growth in vivo. Compared with calcium hydroxide, MTA has demonstrated a greater ability to maintain the integrity of pulp tissue.The clinical and radiological success rate of Biodentine for pulpotomy are extensively being studied. Biodentine has success rates similar to that of mineral trioxide aggregate (MTA) i.e. 94.7% with additional benefits of faster setting time and better odontoblastic activity.The effects of Er.Cr;YSGG laser irradiation on the pulp tissue during a pulpotomy procedure were evaluated histopathologically. Effects on pulp tissues during a pulpotomy procedure by Er.Cr;YSGG laser irradiation are minimal, if appropriate parameters are selected, and this is a potential therapy for pulpotomy of human teeth.
|