| CTRI Number |
CTRI/2024/07/071451 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pulp capping agents for primary teeth |
|
Scientific Title of Study
|
Comparing the Clinical Efficacy of Different Types of Bioceramic Materials for Direct Pulp Capping in Primary Teeth- A Prospective Randomized Clinical Study |
| 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 Sabira Khan |
| Designation |
Post-Graduation Student |
| Affiliation |
M.A. Rangoonwala College of Dental Science and Research Centre |
| Address |
406, Second floor, M A Rangoonwala College of Dental Science and Research Centre, Azam Campus 2390B, K.B, Hidayatulla Rd, Camp, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9892901479 |
| Fax |
|
| Email |
sabirakhan1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav L Talekar |
| Designation |
Post-Graduation Guide |
| Affiliation |
M.A. Rangoonwala College of Dental Science and Research Centre |
| Address |
406, Second floor, M A Rangoonwala College of Dental Science and Research Centre, Azam Campus 2390B, K.B, Hidayatulla Rd, Camp, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9503079151 |
| Fax |
|
| Email |
drabhinavtalekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabira Khan |
| Designation |
Post-Graduation Student |
| Affiliation |
M.A. Rangoonwala College of Dental Science and Research Centre |
| Address |
406, Second floor, M A Rangoonwala College of Dental Science and Research Centre, Azam Campus 2390B, K.B, Hidayatulla Rd, Camp, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9892901479 |
| Fax |
|
| Email |
sabirakhan1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A Rangoonwala College Of Dental Science and Research Centre, Azam Campus 2390B, Hidayatulla Rd, Camp, Pune. |
|
|
Primary Sponsor
|
| Name |
Dr Sabira Khan |
| Address |
406, Second floor, M A Rangoonwala College Of Dental Science and Research Centre, Azam Campus 2390B, Hidayatulla Rd, Camp, Pune. |
| 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 Sabira Khan |
M. A. Rangoonwala College of Dental Sciences & Research Centre |
406, Second floor M A Rangoonwala College of Dental Science and Research Centre, Azam Campus 2390-B, K.B. Hidayatullah Road , Camp, Pune Pune - 411001
Pune
MAHARASHTRA |
9892901479
sabirakhan1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committe M.C.E. Society. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neoliner LC, NuSmile(Texas,U.S.A) |
The tooth will be assessed clinically/radiographically and will be chosen for the procedure if it fits the inclusion criteria. Complete caries excavation will be carried out followed by assessment of the pinpoint exposure of the pulp tissue. Neoliner LC, NuSmile(Texas, U.S.A) will be lined over the exposed pulp and will be restored with composite resin followed by a full coronal restoration. |
| Intervention |
NeoMTA, NuSmile(Texas, U.S.A) |
The tooth will be assessed clinically/radiographically and will be chosen for the procedure if it fits the inclusion criteria.
Complete caries excavation will be carried out followed by assessment of the pinpoint exposure of the pulp tissue.
NeoMTA, NuSmile(Texas, U.S.A) will be placed over the exposed pulp and will be covered by a layer of restorative Glass ionomer Cement.
The tooth will be finally restored with composite resin followed by a full coronal restoration.
|
| Comparator Agent |
Theracal LC, Bisco,(Illinois, U.S.A) |
The tooth will be assessed clinically/radiographically and will be chosen for the procedure if it fits the inclusion criteria. Complete caries excavation will be carried out followed by assessment of the pinpoint exposure of the pulp tissue. Theracal LC, Bisco,(Illinois, U.S.A) will be lined over the exposed pulp and will be restored with composite resin followed by a full coronal restoration. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Pinpoint Exposure surrounded by sound dentin
International Caries Detection and Assessment System (ICDAS) 3-6 Criteria.
Children exhibiting Definitely Positive and Positive behavior according to Frankel Behavior Rating Scale.
Parents willing to be part of study. |
|
| ExclusionCriteria |
| Details |
Presence Of
More than 2/3rd of root resorption
Pathological Mobility
Periapical Pathology
Internal/External resorption |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the dentin bridge formation after use of different types of bioceramic materials for direct pulp capping in primary teeth. The dentin bridge formation will be assessed radiographically |
1 week, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The presence of post-operative pain, swelling, pathological mobility will be evaluated after application of different types of bioceramic materials in primary teeth. These will be clinically evaluated |
1 week, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
03/09/2024 |
| 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="0"
Months="6"
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
|
This is a prospective randomized clinical study. 75 Teeth will be divided into three groups. Group A - MTA (NeoMTA) Group B - Light Cure MTA ( Theracal LC) Group C - Light Cure MTA ( NeoLiner LC)
CLINICAL PROCEDURE - Administration of Local Anesthesia - Isolation of teeth using rubber dam - Cavity preparation using diamond burs (330ss white) at high speed with water coolant. - Caries removal with a spoon excavator according to principles of minimally invasive dentistry ( All of the caries will be excavated from the cavity walls to ensure adequate bonding. - Complete caries removal with a pinpoint pulp exposure surrounded by sound healthy dentin, a DPC procedure will be undertaken. - Hemostasis will be achieved by exerting mild pressure for 2-3 minutes with a sterile cotton pellet moistened with sodium hypochlorite. - Then various pulp capping materials such as MTA, Tharacal LC and Neoliner LC will be placed in the cavity according to manufacturer’s instructions in a randomized manner. - Followed by Full Coronal Restoration.
FOLLOW UP Follow up of the restorations will be set at 1 week, 3 months, 6 months.
|