| CTRI Number |
CTRI/2021/07/034842 [Registered on: 14/07/2021] Trial Registered Prospectively |
| Last Modified On: |
02/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pulpotomy in permanent teeth with symptoms of irreversible pulpitis |
|
Scientific Title of Study
|
Outcome of partial pulpotomy vs full pulpotomy using biodentine in mature permanent molar with clinical symptoms indicative of irreversible pulpitis: A randomized clinical study |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| dr.hcbaranwal@gmail.com |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Yadav |
| Designation |
Junior Resident |
| Affiliation |
FODS, IMS, BHU, Varanasi |
| Address |
Room no.6, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, IMS, BHU
Nagarjun Girls Hostel, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07376645880 |
| Fax |
|
| Email |
drjyotiyadav2024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harakh Chand Baranwal |
| Designation |
Professor |
| Affiliation |
FODS, IMS, BHU, Varanasi |
| Address |
Room no.6, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, IMS, BHU
Room no.6, Department of conservative dentistry and endodontics, FODS, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07376645880 |
| Fax |
|
| Email |
dr.hcbaranwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Yadav |
| Designation |
Junior Resident |
| Affiliation |
FODS, IMS, BHU, Varanasi |
| Address |
Room no.6, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, IMS, BHU
Nagarjun Girls Hostel, IMS, BHU
UTTAR PRADESH
221005
India |
| Phone |
07376645880 |
| Fax |
|
| Email |
drjyotiyadav2024@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of dental sciences,IMS,BHU,Varanasi, 221005, deanheaddentistry@gmail.com |
|
|
Primary Sponsor
|
| Name |
Jyoti yadav |
| Address |
Room no. 6, 3rd floor, Faculty of dental sciences, IMS, BHU, Varanasi, UP |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 |
| Jyoti yadav |
BHU, Varanasi |
Room no.6, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, IMS, BHU
Nagarjun Girls Hostel, IMS, BHU
Varanasi
UTTAR PRADESH |
07376645880
drjyotiyadav2024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Institute of medical sciences, BHU |
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 |
Full pulpotomy |
Full pulpotomy(Complete pulpotomy) is a procedure that involves removing the whole coronal portion of the vital pulp to the level of canal orifices while leaving the remaining radicular portion healthy. This technique has a better chance of extracting contaminated and irreversibly inflamed tissue than partial pulpotomy |
| Intervention |
Partial pulpotomy |
A partial pulpotomy entails the removal of 2–3 mm of pulp tissue from the inflamed coronal pulp underneath the exposure, followed by the application of a suitable agent to the remaining coronal pulp and the placement of a hermetic restoration. In contrast to a full pulpotomy, partial pulpotomy is considered a more conservative technique. Additionally, it preserves the cell-rich coronal pulp, which provides constant deposition of cervical dentin and decreases the chance of root canal obliteration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
•Mature permanent molar
•Strong and prolonged reaction to cold, which can last for minutes.
•Spontaneous dull pain that can be more or less suppressed by pain medication clinical diagnosis of irreversible pulpitis with/without periapical rarefaction.
•No signs of pulpal necrosis including sinus tract or swelling
|
|
| ExclusionCriteria |
| Details |
• Non restorable teeth.
• Negative response to cold testing, the presence of sinus tract or swelling.
•Bleeding could not be controlled after pulpotomy in 6 minutes .
•Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic
•Medically compromised patient
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution of pain, sensitivity and periapical lesion |
3 Month, 6 month, 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dentine bridge formation |
3 Month, 6 Month, 12 Month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
21/07/2021 |
| 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="1"
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 - NO
|
|
Brief Summary
|
1. To evaluate
the outcome of clinical and radiographic success of partial pulpotomy using
biodentine in mature permanent molar with clinical symptoms indicative of
irreversible pulpitis.
2. To evaluate
the outcome of clinical and radiographic success of full pulpotomy using
biodentine in mature permanent molar with clinical symptoms indicative of
irreversible pulpitis.
To
compare clinical and radiographic outcome
of partial pulpotomy and full
pulpotomy using biodentine in mature permanent molar with clinical symptoms
indicative of irreversible pulpitis |