| CTRI Number |
CTRI/2025/10/096469 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision between two methods of managing root canal space in patients who want to replace their missing teeth with support of adjacent teeth which will require root canal treatment, One method is regular root canal treatment and another is partial root canal treatment with biodentine material. |
|
Scientific Title of Study
|
A Comparative Clinical evaluation of abutment teeth undergoing full coronal pulpotomy with Biodentine and intentional root canal treatment which receives a fixed partial denture – A Split mouth block 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 |
Dr Divyameena Bommiah |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental College |
| Address |
Room No:7, Department of Conservative Dentistry and Endodontics, VMSDC, Sankari Main Road, Salem
No2 Palaniappa Nagar, hasthampatty
Madurai
TAMIL NADU
636308
India |
| Phone |
09952463468 |
| Fax |
|
| Email |
drdivyameenab@vmsdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divyameena Bommiah |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental College |
| Address |
Room No:7, Department of Conservative Dentistry and Endodontics, VMSDC, Sankari Main Road, Salem
No2 Palaniappa Nagar, hasthampatty
Madurai
TAMIL NADU
636308
India |
| Phone |
09952463468 |
| Fax |
|
| Email |
drdivyameenab@vmsdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divyameena Bommiah |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental College |
| Address |
Room No:7, Department of Conservative Dentistry and Endodontics, VMSDC, Sankari Main Road, Salem
No2 Palaniappa Nagar, hasthampatty
Madurai
TAMIL NADU
636308
India |
| Phone |
09952463468 |
| Fax |
|
| Email |
drdivyameenab@vmsdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Internal SEED Money grant from Vinayaka Missions Research Foundation (Deemed To be University), Sankari Main Road, Ariyanoor, Salem, Tamil Nadu, India - 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Research Foundation (Deemed to be University) |
| Address |
Sankari Main road Ariyanoor Salem 636308 |
| Type of Sponsor |
Research institution |
|
|
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 Divyameena |
Vinayaka Missions Sankarachariyar Dental College |
Room No:7, Department of Conservative Dentistry and Endodontics,Sankari Main road, Ariyanoor, Salem - 636308
Salem
TAMIL NADU |
09952463468
drdivyameenab@vmsdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMS Dental College Instituitional Ethics Commitee,Vinayaka Missions Sankarachariyar Dental College |
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 Coronal pulpootmy procedure with Biodentine |
Full coronal pulpal tissue will be removed and Biodentine tricalcium silicate bioactive material will be placed and composite restoration will be given. This is a treatment procedure.
Time: Single visit |
| Comparator Agent |
Root canal treatment with Bioactive sealer |
conventional Root canal treatment will be done with regular protocols and sealed with Bioactive sealer and Gutta percha |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Abutment teeth indicated for intentional root canal treatment receiving fixed partial denture
Maxillary and mandibular teeth responding to normal sensitivity that relieved after removal of the stimuli to cold pulp sensibility testing
Teeth with no caries or initial caries extending only to the enamel will be included
|
|
| ExclusionCriteria |
| Details |
Maxillary and mandibular third molars
Patients with previous history or present scenario of severe spontaneous pain / continuous throbbing pain / nocturnal pain / radiating pain.
Teeth with dental caries extending into dentin and pulp.
Percussion test showing severe pain.
Periapical radiograph showing PDL space widening or loss of lamina dura along the entire length of root / roots
Teeth that requires post and core.
Concerned teeth treated previously.
Teeth responding to exaggerated sensitivity/pain, lingering pain or no response to cold pulp sensibility testing.
Teeth with calcification,resorption, furcation involvement, and vertical bone loss.
Radicular pulp that doesn’t achieve hemostasis within 10mins after access opening in coronal pulpotomy procedure.
|
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and Radiographic outcome of coronal pulpotomy and intentional root canal treatment procedure of the abutment teeth |
1 week, 3months, 6months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Survival Analysis of Fixed partial denture |
1 week, 3months, 6months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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) |
Open to Recruitment |
|
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
|
Abutment
teeth indicated for fixed partial denture, presents with challenge of
inadequate prosthetic space that requires an endodontic management to achieve
sufficient prosthetic requirements. Studies
have shown that vital teeth under a fixed partial denture had better prognosis
when compared to root canal treated abutment leading to alternative treatment
like full coronal pulpotomy which gives a win – win situation of achieving
sufficient prosthetic space as well as maintains the radicular pulp vitality has
to led to this clinical trial. 41
patients with 82 abutment teeth indicated for endodontic management will be
included after satisfying the inclusion criteria. Group 1(n=41) Full Coronal
Pulpotomy with biodentine and Group 2(n=41) intentional root canal treatment
will be block randomised in every patient, followed by fixed partial denture.1year
follow up is done to assess the clinical and radiographic success of the
treatment procedure using respective indices.
|