| CTRI Number |
CTRI/2025/03/082555 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study Comparing Two Methods for Treating Very Deep Cavities in Mature Permanent Teeth with Pulpitis (tooth inflammation) that Doesnt Cause Spontaneous Pain. |
|
Scientific Title of Study
|
Comparative Evaluation of Selective Caries Removal and Partial
Pulpotomy Performed For Management of Extremely Deep Carious
Lesion With Non-Spontaneous Symptomatic Pulpitis In Mature
Permanent Teeth: A Randomized Clinical 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 Pranav Kagane |
| Designation |
Junior Resident |
| Affiliation |
center for dental education and research , AIIMS , new delhi |
| Address |
Department of conservative dentistry and endodontics, third floor, post graduate clinic, CDER, AIIMS new Delhi, Delhi, 110029, India
FIRST FLOOR, HOUSE NO. 141/2/2, GAUTAM NAGAR, NEW DELHI, DELHI, 110029, INDIA
New Delhi
DELHI
110029
India |
| Phone |
9921602605 |
| Fax |
|
| Email |
pkagane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Additional Professor |
| Affiliation |
center for dental education and research , AIIMS , new delhi |
| Address |
room no. 308 ,Division of Conservative Dentistry and Endodontics,
Centre for Dental Education and Research,
All India Institute of Medical Sciences, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9540055001 |
| Fax |
|
| Email |
kumarvijay29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Additional Professor |
| Affiliation |
center for dental education and research , AIIMS , new delhi |
| Address |
room no. 308 ,Division of Conservative Dentistry and Endodontics,
Centre for Dental Education and Research,
All India Institute of Medical Sciences, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9540055001 |
| Fax |
|
| Email |
kumarvijay29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics, third floor, post graduate clinic, CDER, AIIMS new Delhi, Delhi, 110029, India |
|
|
Primary Sponsor
|
| Name |
Dr Pranav Kagane |
| Address |
Department of Conservative Dentistry and Endodontics, third floor, post graduate clinic, CDER, AIIMS new Delhi, 110029, India |
| Type of Sponsor |
Other [self] |
|
|
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 Pranav Kagane |
CDER, AIIMS , New delhi |
Post graduate clinic, 3rd floor, Centre for dental education and research, AIIMS New delhi Delhi
New Delhi
DELHI |
9921602605
pkagane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR, NEW DELHI 110029 |
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 |
Indirect Pulp Capping |
Indirect pulp capping is a dental procedure used to protect a tooths inner living tissue (pulp) when decay gets close to it. The duration of a indirect pulp capping procedure is approximately one hour. Instead of removing all the decay, the dentist leaves a thin layer and covers it with a special material. This helps the tooth heal itself and avoid a more invasive root canal treatment. |
| Comparator Agent |
partial pulpotomy |
Partial pulpotomy is a dental procedure used to save a tooth that has been damaged by decay or injury. The duration of a partial pulpotomy procedure is approximately one hour. It involves removing only a small portion of the tooths inner living tissue (pulp) thats infected or inflamed. This treatment helps preserve the tooths vitality while addressing the immediate problem, potentially avoiding the need for a full root canal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy patients of either gender belonging to 18 to 40
age with mature permanent maxillary and mandibular
molar teeth
• Teeth with extremely deep carious lesions i.e. carious
lesion penetrating the entire thickness of the dentin,
without a radio-dense zone.
• Teeth with established clinical diagnosis of nonspontaneous symptomatic pulpitis (initial and mild
pulpitis)
• Teeth with positive response to cold and electric pulp
test.
|
|
| ExclusionCriteria |
| Details |
Deep carious lesions extending ≥3/4 of the dentine
thickness, with a visible radiopaque zone separating
the carious lesion from the pulp, of mature permanent
teeth with spontaneous symptomatic irreversible
pulpitis
• Extremely deep carious lesion with periapical
rarefaction.
• Teeth with clinical diagnosis of spontaneous
symptomatic pulpitis (Moderate and severe pulpitis)
• Teeth with cracks, cusp fractures, subgingival caries
and poor periodontal health
• Patients with systemic conditions which could
compromise the healing.
• Patients not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the outcome of mature permanent teeth with extremely deep carious
lesion and non-spontaneous symptomatic pulpitis managed by
a. Indirect pulp capping with selective caries removal
b. Partial Pulpotomy
|
3,6,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the outcome of Indirect pulp capping with selective caries
removal and partial pulpotomy with hydraulic calcium silicate cement for
management of extremely deep carious lesion with non-spontaneous
symptomatic pulpitis in mature permanent teeth.
|
3,6,12 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 2 |
|
Date of First Enrollment (India)
|
28/03/2025 |
| 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="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
The study is a randomized control trial with parallel study design for managing deep and extremely deep tooth decay in mature teeth, where the pulp may be at risk. It compares two treatment methods: selective caries removal, a minimally invasive approach that preserves more of the tooth and reduces pulp risks, and pulpotomy, a more invasive procedure that involves removing part of the pulp but carries higher risks. The study highlights the need for a clinical trial to determine the best approach for treating extremely deep caries while protecting the pulp. with patient follow up at 3, 6, and 122 months |