FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/12/060901 [Registered on: 28/12/2023] Trial Registered Prospectively
Last Modified On: 22/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial comparing treatment of teeth with pain and sensitivity by 2 methods. 
Scientific Title of Study   Outcome of Full pulpotomy vs Partial radicular pulpotomy in mature permanent teeth indicative of Irreversible Pulpitis using Biodentine - A Randomized Controlled 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  Vijul 
Designation  Academic Junior Resident 
Affiliation  Faculty of Dental Sciences IMS BHU 
Address  3rd floor Conservative Dentistry and Endodontics Faculty of Dental Sciences Trauma Centre Banaras Hindu University Varanasi
3rd floor Conservative Dentistry and Endodontics Faculty of Dental Sciences Trauma Centre Banaras Hindu University Varanasi Uttar Pradesh 221005
Varanasi
UTTAR PRADESH
221005
India 
Phone  7380722505  
Fax    
Email  vijul6638@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H C Baranwal 
Designation  Professor 
Affiliation  Faculty of Dental Sciences 
Address  Conservative Dentistry and Endodontics Faculty of Dental Sciences Trauma Centre BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415286900  
Fax    
Email  drhcbaranwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vijul 
Designation  Academic Junior Resident 
Affiliation  Faculty of Dental Sciences 
Address  Conservative Dentistry and Endodontics, Faculty of Dental Sciences, Trauma Centre, BHU, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  7380722505  
Fax    
Email  vijul6638@gmail.com  
 
Source of Monetary or Material Support  
3rd floor conservative dentistry and endodontics IMS BHU Varanasi Uttar Pradesh 221005 
 
Primary Sponsor  
Name  Faculty of Dental Sciences 
Address  Conservative Dentistry and Endodontics, Faculty of Dental Sciences, Trauma Centre, BHU, Varanasi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr H C BARANWAL  FACULTY OF DENTAL SCIENCES  3rd floor Conservative Dentistry and Endodontics, Faculty of Dental Sciences, Trauma Centre, BHU, Varanasi
Varanasi
UTTAR PRADESH 
09415286900

drhcbaranwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IMS, Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FULL PULPOTOMY  After clinical and radiographic examination , the tooth will be anaesthetized using 2% lidocaine and then isolated with a rubber dam .The tooth surface will be disinfected with 5.25% sodium hypochlorite and then cavity will be prepared . Caries will be removed with round bur and low speed hand piece under sterile water spray. After complete carious excavation, pulp tissue will be removed to the level of canal orifice using sterile round bur with a high speed hand- piece under water coolant. The bleeding will be controlled using a cotton pellet saturated with 3% sodium hypochlorite solution. Biodentine will be mixed and gently placed over the pulp tissue in 2-3 mm thickness and allowed to set for 12 minutes. A layer of glass ionomer cement will be placed and after that a composite restoration will be placed and postoperative periapical radiograph will be taken. Pain will be assessed on 1st, 2nd and 7th day after treatment. Radiographs will be taken at an interval of 3, 6 and 12months. 
Comparator Agent  PARTIAL RADICULAR PULPOTOMY  After clinical and radiographic examination, the tooth will be anaesthetized using 2% lidocaine and then isolated with a rubber dam. The tooth surface will be disinfected with 5.25% sodium hypochlorite and then cavity will be prepared. Caries will be removed with round bur and low speed hand piece under sterile water spray. After complete carious excavation, pulp tissue will be removed to the level of canal orifice using sterile round bur followed by removal of 3-4mm of radicular pulp from the level of orifice using a flat-ended tapered fissure bur with a high speed hand- piece under water coolant. The bleeding will be controlled using a cotton wrapped around reamer saturated with 3% sodium hypochlorite solution in the canals. Biodentine will be mixed and gently placed over the pulp tissue in 2-3 mm thickness and allowed to set for 12 minutes. A layer of glass ionomer cement will be placed and after that a composite restoration will be placed and postoperative periapical radiograph will be taken. Pain will be assessed on 1st, 2nd and 7th day after treatment. Radiographs will be taken at an interval of 3, 6 and 12months.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  40.00 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 thermal testing, the presence of sinus tract or swelling.
Bleeding could not be controlled after pulpotomy in 5 minutes.
Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic
Medically compromised patient.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Healing of periapical lesion on radiographic evaluation and resolution of clinical symptoms  6 - 12 MONTHS. 
 
Secondary Outcome  
Outcome  TimePoints 
Response to thermal testing   6-12 MONTHS 
 
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 1/ Phase 2 
Date of First Enrollment (India)   05/01/2024 
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  

Permanent teeth diagnosed with “irreversible pulpitis” have long been implied to have an irreversibly damaged dental pulp that is beyond repair and warranting root canal treatment. However, newer clinical approaches such as pulpotomy, a minimally invasive and biologically based procedure have re-emerged to manage teeth with pulpitis.

Prevention of disease or its termination at the earliest possible stage, along with the preservation of maximum healthy viable tissue is an indispensable element of any treatment modality and forms the fundamental basis of minimally invasive dentistry. Pulpotomy is one such procedure that focuses on the preservation of pulp and its functions like proprioception, innervation and vascularisation. Compared to root canal treatment (RCT), it is less time-consuming and easier to perform technically. Teeth treated with RCT are at risk of structural failure, loss of sensation of environmental changes (potentially leading to more or worse caries), rejection of the foreign material, reinfection, and occurrence of apical periodontitis.

The rationale behind root canal obturation has inclined toward mechanical rather than biological treatment. A recent systematic review has concluded that VPTs, specifically full pulpotomy, have exhibited a high success rate in managing carious pulp exposure of cases with IP and can be a suitable potential substitute for RCT.

Despite the work to date, controversy still persists regarding the optimal level of endodontic therapy. This is partly due to the lack of distinction between pulpal inflammation and  radicular infection. Nicholls and Baume, have shown that the inflamed pulp lends itself to vital apex treatment. Therefore, to overcome the drawbacks of RCT, vital apex treatment and vital pulp therapy have been developed. Vital apex treatment may be defined as radicular pulpotomy or biopulpectomy.

 
Close