| CTRI Number |
CTRI/2021/06/033971 [Registered on: 03/06/2021] Trial Registered Prospectively |
| Last Modified On: |
26/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of deep decay and pain in teeth using a new bioceramic material |
|
Scientific Title of Study
|
Partial and full pulpotomy outcomes in cariously exposed permanent posterior teeth using a bioceramic material |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav Kulkarni |
| Designation |
Reader |
| Affiliation |
Terna Dental College |
| Address |
205, Department of conservative dentistry and endodontics,
Terna dental college and hospital
Sector 22, Nerul West, Navi Mumbai
205, Department of conservative dentistry and endodontics,
Terna dental college and hospital
Sector 22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9769234101 |
| Fax |
|
| Email |
drgauravkulkarni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Kulkarni |
| Designation |
Reader |
| Affiliation |
Terna Dental College |
| Address |
205, Department of conservative dentistry and endodontics,
Terna dental college and hospital
Sector 22, Nerul West, Navi Mumbai
205, Department of conservative dentistry and endodontics,
Terna dental college and hospital
Sector 22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9769234101 |
| Fax |
|
| Email |
drgauravkulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Kulkarni |
| Designation |
Reader |
| Affiliation |
Terna Dental College |
| Address |
205, Department of conservative dentistry and endodontics,
Terna dental college and hospital
Sector 22, Nerul West, Navi Mumbai
205, Department of conservative dentistry and endodontics,
Terna dental college and hospital
Sector 22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9769234101 |
| Fax |
|
| Email |
drgauravkulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| dept of conservative dentistry and endodontics
terna dental college nerul navi mumbai |
|
|
Primary Sponsor
|
| Name |
Gaurav Kulkarni |
| Address |
Dept of conservative dentistry and endodontics, Terna dental college and hospital, Nerul, Navi mumbai |
| 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 Gaurav Kulkarni |
Dept of Conservative Dentistry and Endodontics |
Room No. 205, Terna Dental College
Sector 22
Nerul West
Navi Mumbai
Thane
MAHARASHTRA |
9769234101
drgauravkulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Ethics Committee |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Partial/full pulpotomy |
After excavating caries (decay) under local anaesthesia and rubber dam isolation, if there is no pulp exosure, a well-sealing final restoration would be placed and the patient would be excluded from the study. If caries excavation results in pulp exposure, the pulp will be amputated either partially or completely depending on the time taken to stop bleeding. After cleaning the cavity thoroughly with sodium hypochlorite solution, the bioceramic material would be placed on top of the amputated pulp stumps. A well sealing restoration will be placed on top of this. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Permanent mature posterior teeth with deep to extremely deep caries
2) Teeth that give positive response to pulp vitality testing
3) Teeth in which vitality is confirmed clinically on gaining access
4) Teeth with or without periapical rarefaction
5) Teeth with probing depth and mobility within normal limits
6) Patients that agree to participate in the study |
|
| ExclusionCriteria |
| Details |
1)Teeth with immature apices
2) Teeth where caries does not result in pulp exposure
3) Teeth with extensive caries that are unrestorable
4) teeth with intraoral/extraoral swelling and/or associated sinus tract
5) teeth subjected to abnormal stresses
6) medically compromised patients, pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maintenance of normal pulp vitality and normal periapical tissues |
3 weeks, 6 months, 12 months, 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Formation of dentinal bridge as assessed radiographically |
6 months, 12 months, 18 months, and 24 months |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
07/06/2021 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drgauravkulkarni@gmail.com].
- For how long will this data be available start date provided 18-04-2024 and end date provided 18-04-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To evaluate the effect on the outcome of cariously exposed permanent posterior teeth treated with partial/complete pulpotomy using a bioceramic material. The novel (but commercially available) bioceramic material will be placed as the medicament over the amputated pulp stumps and a permanent, well-sealing restoration would be placed on top of it. The biological response would be assessed at fixed follow-up intervals where defined clinical and radiographic parameters will be assessed. |