| CTRI Number |
CTRI/2023/10/059045 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
20/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Maintaining the integrity of teeth using new filling materials |
|
Scientific Title of Study
|
Use of a collagen sponge to regenerate the coronal pulp after pulp chamber pulpotomy - a superiority trial in healthy teeth |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences Manipal |
| Address |
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal
ANAGHA Rabindranatha Tagore Road Opp MGM college Kunjibettu Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences Manipal |
| Address |
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal
ANAGHA Rabindranatha Tagore Road Opp MGM college Kunjibettu Udupi Karnataka
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences Manipal |
| Address |
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal
ANAGHA Rabindranatha Tagore Road Opp MGM college Kunjibettu Udupi Karnataka
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Endodontics University of Zurich Switzerland |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences |
| Address |
Madhav Nagar Manipal Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Matthias Zehnder |
University of Zurich Switzerland |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vasudev Ballal |
Manipal College of Dental Sciences |
Department of Conservative Dentistry and Endodontics Room no 2 Manipal College of Dental Sciences Madhav Nagar Manipal Karnataka
Udupi
KARNATAKA |
09880626167
drballal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Teeth requiring extraction for orthodontic treatment |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biodentine |
Biodentine will be used for pulp regeneration for 3 months |
| Intervention |
Collagen sponge |
Collagen sponge will be used for pulp regeneration for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients to be enrolled in this study will be healthy adults (18 years and older) who need their contralateral premolars extracted for orthodontic reasons. |
|
| ExclusionCriteria |
| Details |
Patients with caries, trauma, periapical lesions or periodontal involvement and systemically ill individuals will not be asked to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| vitality of the treated teeth and if any pain present on the treated teeth will be assessed |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| discoloration of the treated teeth after three months of treatment will be assessed |
3 months |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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 3 |
|
Date of First Enrollment (India)
|
30/10/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Full pulpotomy will be performed on 18 contra lateral premolar teeth in patients undergoing orthodontic treatment. In one group, Collagen sponge will be placed in the pulp chamber following pulpotomy, and in the other group Biodentine will be placed and the access cavity will be restored with resin composite. After three months, vitality and discoloration of the teeth will be assessed. Representative teeth will be extracted and assessed for histopathology of pulp. |