| 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
|
|
|
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
|
|
|
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. |