| CTRI Number |
CTRI/2024/11/076174 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical evaluation of pulpotomy using biomtaplus and biodentine. |
|
Scientific Title of Study
|
Evaluation of clinical performance of two calcium silicate-based materials for pulpotomy: A randomized clinical 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 |
Yellapu Shenkari Indumathi |
| Designation |
Post Graduate Student |
| Affiliation |
DRS. SUDHA & NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES |
| Address |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Chinaoutpalli
521286
Krishna district, Vijayawada.
Andhra Pradesh
India
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
07032491930 |
| Fax |
|
| Email |
indumathi090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Janga Ravi Kumar |
| Designation |
professor |
| Affiliation |
DRS. SUDHA & NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES |
| Address |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Chinaoutpalli
521286
Krishna district, Vijayawada.
Andhra Pradesh
India
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
521286 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janga Ravi Kumar |
| Designation |
professor |
| Affiliation |
DRS. SUDHA & NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES |
| Address |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Chinaoutpalli
521286
Krishna district, Vijayawada.
Andhra Pradesh
India
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
521286 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yellapu Shenkari Indumathi Post graduate student Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences Department of Conservative Dentistry and Endodontics Room No. 7 Gannavaram 521286 Chinnautpalli Vijayawada AndhraPradesh |
|
|
Primary Sponsor
|
| Name |
Yellapu Shenkari Indumathi |
| Address |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences Department of Conservative Dentistry and Endodontics Room No. 7 Gannavaram 521286 Chinnaoutpalli Vijayawada AndhraPradesh |
| 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 Yellapu Shenkari Indumathi |
DRS.SUDHA AND NAGESWARA RAO SIDDHRATHA INSTITUTE OF DENTAL SCIENCES |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Room No 7: Department Of Conservative Dentistry and Endodontics, Pg Block.
Chinaoutpalli
521286
Krishna district, Vijayawada.
Andhra Pradesh
India
Krishna
ANDHRA PRADESH |
7032491930
indumathi090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DRS. SUDHA & NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biodentine |
Biodentine has emerged in recent years as an innovative bioactive dentine substitute. Its superior physical properties, improved handling, and various clinical applications have made biodentine popular in dentistry. It has been advocated for vital pulp therapy, root perforations, resorptions, retrograde fillings.The setting period of the material is as short as 9–12 minutes. This shorter setting time is an improvement compared to other calcium silicate materials.It is a single time application where 1-2 milligrams of paste is applied in tooth and will be restored permanently using a permanent restoration. |
| Intervention |
Biomtaplus |
BIO MTA+ is for dental treatment as a material for filling and remineralization of root canals. Additionally, it contains hydroxyapatite which is a natural component of bones. BIO MTA+ has 3 times higher durability in comparison to traditional MTA materials. It is a single time application where 1-2 milligrams of paste is applied in tooth and will be restored permanently using a permanent restoration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients who are asymptomatic/symptomatic reversible pulpitis with deep dental caries in posterior teeth close to pulp chamber and bleeding easily controlled after pulp exposure and site of exposure is large. |
|
| ExclusionCriteria |
| Details |
very small pulp exposure or any h/o of spontaneous pain, periapical lesion and bleeding not controlled after pulp exposure |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
More than 75% of patients receiving pulpotomy by the materials used in the study will be preserving the pulp vitality
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In more the 75% patients the signs & symptoms of pulpitis such as tooth ache will be cured |
1 YEAR |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The optimal prognosis of vital pulp therapy is based on the elimination
of etiologic factors with complete removal of diseased and contaminated tissues
as well as the appropriate restoration of the tooth. Therefore, vital pulp therapy
is preferred to reduce the risk of infection and further damage to the pulp
with a material that should be biocompatible, provide a biological seal, and
prevent bacterial leakage. Currently calcium silicate-based materials are considered
for vital pulp therapies like pulp capping and pulpotomy procedures. Several
studies have shown successful results using Biodentine and MTA as pulpotomy
agents but, there are very few clinical studies till date comparing the calcium
silicate materials used for pulpotomy in permanent teeth. |