| CTRI Number |
CTRI/2019/12/022559 [Registered on: 30/12/2019] Trial Registered Prospectively |
| Last Modified On: |
12/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to check Result of Treating Painful Decayed Teeth using Two Different Techniques of Pulp Removal. |
|
Scientific Title of Study
|
Outcome Assessment of Partial and Full Pulpotomy Using Biodentine in Cariously Exposed Mature Molars With Irreversible Pulpitis: A Clinical Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashima Jassal |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute Of Dental Sciences |
| Address |
Third Floor, Department Of Conservative Dentistry and Endoodntics, MAIDS
BSZ Marg, MAMC Complex, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9069610885 |
| Fax |
|
| Email |
ashimajassal012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Talwar |
| Designation |
Director Principal, Professor and Head |
| Affiliation |
Maulana Azad Institute Of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, third floor, MAIDS
BSZ Marg, MAMC Complex, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9654700950 |
| Fax |
|
| Email |
sangeeta.talwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashima Jassal |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute Of Dental Sciences |
| Address |
third floor, Department of Conservative Dentistry and Endodontics, MAIDS, BSZ Marg, MAMC Complex, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9069610885 |
| Fax |
|
| Email |
ashimajassal012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Conservative Dentistry And Endodontics, Maulana Azad Institute Of Dental Sciences, New Delhi-02 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Institute Of Dental Sciences |
| Address |
BSZ Marg, MAMC Complex, New DElhi-110002 |
| 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 Ashima Jassal |
Maulana Azad Institute Of Dental Sciences |
Third floor, department of Conservative Dentistry and Endodontics, MAIDS, BSZ Marg, MAMC Complex, New Delhi-110002
Central
DELHI |
9069610885
ashimajassal012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAIDS Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Full pulpotomy |
Full pulpotomy using biodentine in Cariously Exposed Mature Molars With Irreversible Pulpitis |
| Intervention |
Partial pulpotomy |
Partial pulpotomy using biodentine in Cariously Exposed Mature Molars With Irreversible Pulpitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical inclusion criteria
1.The patient should be more 18 years old
2.Patient should have non-contributory Medical history
3.Tooth with deep Class I caries presenting with signs and symptoms indicative of irreversible pulpitis.
4.History of spontaneous pain and/or nocturnal pain which aggravates on lying down.
5.Patient reporting with spontaneous pain and/or with sharp and lingering pain upon cold testing using Endo-Ice and early exaggerated response with electric pulp testing.
6.A restorable tooth with probing pocket depth(<3mm) and mobility within normal limits.
7.Complete caries removal will result in pulpal exposure.
8.Bleeding from the pulp exposure site stops with 2.5-3% NaOCl irrigation within 10 minutes.
Radiological inclusion criteria
1.Extremely deep caries (penetrating the entire thickness of the dentine without a radiopaque zone
separating the lesion from the pulp)
2.Absence of periapical or furcation changes in the radiograph
|
|
| ExclusionCriteria |
| Details |
1.Tooth having unexposed pulp after complete caries removal.
2.Tooth exhibiting uncontrolled pulpal haemorrhage during the procedure lasting more than 10 minutes.
3.Exposed pulp tissue appearing necrotic, judged by absence of bleeding or presence of pale necrotic pulp tissue.
4. Presence of internal or pathologic external root resorption, calcification or pulp canal obliteration. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Absence of spontaneous pain and pain during chewing,Lack of swelling and sinus tract, fistula |
pre operative, post operative, 2 weeks, 3 months and 6 months of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
No periapical or furcation changes and Absence of internal and/or external root resorption in the radiograph
|
pre operative, post operative, 2 weeks, 3 months and 6 months of procedure |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This single blind clinical trial will be conducted on the patients with signs and symptoms of irreversible pulpitis due to cariously exposed molar teeth. After inclusion and exclusion criteria, 50 patients will be enrolled in the study which will be randomized to two groups of 25 each (Group 1 and Group 2). in Group 1, Partial Pulpotomy will be performed after complete excavation of caries and hemostasis using NAOCl followed by 2-3mm removal of coronal pulp. In group 2, Full pulpotomy will be performed after complete excavation of caries and hemostasis using NAOCl followed by complete removal of coronal pulp.the teeth will then be restored with Biodentine.After 14 days, some amount of biodentine will be trimmed and replaced with composite followed by the post operative radiograph.Patients will be followed up for after 3 months and 6 months to evaluate clinical and radiological success of the pulpotomized teeth. The outcome assessment of Partial and Full Pulpotomy will be analysed using appropriate statistical tests. |