| CTRI Number |
CTRI/2023/06/053989 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pulpotomy in mature permanent tooth using various biomaterials |
|
Scientific Title of Study
|
A Comparative evaluation of treatment outcomes of coronal pulpotomy using biodentine alone versus combination of PRF & biodentine in mature permanent mandibular molars diagnosed with irreversible pulpitis: a randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shobhita Garg |
| Designation |
MDS First Year Conservative Dentistry and Endodontics |
| Affiliation |
Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9878239025 |
| Fax |
|
| Email |
shobita.garg98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShweta Verma |
| Designation |
Professor |
| Affiliation |
Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh
Department of Conservative Dentistry and Endodontics, Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9418476681 |
| Fax |
|
| Email |
drshwetaverma053@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShweta Verma |
| Designation |
Professor |
| Affiliation |
Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh
Department of Conservative Dentistry and Endodontics, Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9418476681 |
| Fax |
|
| Email |
drshwetaverma053@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Himachal Dental college, Sundernagar, Mandi, Himachal Pradesh,175019 |
|
|
Primary Sponsor
|
| Name |
Shobhita Garg |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College, Sunder Nagar, Mandi, Himachal Pradesh |
| 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 |
| Shobhita Garg |
Himachal dental College, sundernagar |
Room No.3, Department Of Conservative and Endodontics
Mandi
HIMACHAL PRADESH |
9878239025
shobita.garg98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE OF HIMACHAL DENTAL COLLEGE, SUNDERNAGAR |
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 |
Group A- Biodentine |
Pulpotomy of permanent tooth diagnosed with irreversible pulpitis using
Biodentine
dose- 2mm thickness
frequency- single administration
route of administration- orally inserted over the pulp inside the prepared tooth structure
total duration- lifetime
followed by placement of resin based restorative material
dose- 4mm thickness
frequency- single administration
route of administration- orally inserted over the biodentine inside the prepared tooth structure
total duration- lifetime |
| Comparator Agent |
Group A- PRF and Biodentine |
Pulpotomy of permanent tooth diagnosed with irreversible pulpitis using PRF
dose- packed in root canal chamber
Biodentine
dose- 2mm thickness
frequency- single administration
route of administration- orally inserted over the pulp inside the prepared tooth structure
total duration- lifetime
followed by placement of resin based restorative material
dose- 4mm thickness
frequency- single administration
route of administration- orally inserted over the biodentine inside the prepared tooth structure
total duration- lifetime |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Peri-apical widening (mild)may or msy not be present
2. Sensitivity to hot and cold
3. Acute pain
4. Tenderness on percussion may or may not be present
5. Mandibular first and second permanent molar
6. Limited carious extent that does not require prosthetic treatment
|
|
| ExclusionCriteria |
| Details |
1. Periapical lesion
2. Excessive coronal damage due to caries
3. Pregnancy
4. Chronic Lesion
5. History of pain, long back
6. Presence of swelling
7. Presence of mobility
8. Periodontal involvement ( presence of pocket) |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Clinical Evaluation - Absence of symptomatology that is, pain, swelling, tender
on percussion, mobility.
• Radiographic Assessment- Absence of evident pathosis, example, root
resorption furcal pathosis, new periapical lesion and/or resolution of apical
widening.
• Pulp Sensibility Testing-Positive EPT response (higher threshold values than
baseline values) |
Follow up of 1, 3, 6 months will be taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Clinical Evaluation - Absence of symptomatology that is, pain, swelling, tender
on percussion, mobility.
• Radiographic Assessment- Absence of evident pathosis, example, root
resorption furcal pathosis, new periapical lesion and/or resolution of apical
widening.
• Pulp Sensibility Testing-Positive EPT response (higher threshold values than
baseline values) |
Follow up of 8 , 12 months will be taken |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/06/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of this binary, non-inferiority randomized clinical controlled trial is to compare the long-term success of coronal pulpotomies in human permanent molars with irreversible pulpitis using Biodentine alone versus those performed with Biodentine and PRF. The clinical/radiographic outcomes of these cases will be evaluated at regular follow-up periods. In this binary non-inferiority randomized clinical controlled trial, treated teeth will be considered successful if there are absence of clinical symptoms and no evidence of internal or external root resorption or any further treatment (i.e., extraction due to pathology or pulpectomy) is necessary. |