| CTRI Number |
CTRI/2023/11/059915 [Registered on: 16/11/2023] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check the success rate of indirect pulp therapy with selective removal of carious dentin in teeth that are permanent. |
|
Scientific Title of Study
|
Evaluation of the Efficacy of Indirect Pulp Therapy with Selective Removal of Carious Dentin in Permanent Teeth: An in Vivo Study with One Year Follow Up |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KHUSHBU |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT Dental College Hospital And Research Institute Gurugram, Haryana 122505 |
| Address |
RZ-23 Phase-4 Prem Nagar Najafgarh, New Delhi-110043
New Delhi
DELHI
110043
India |
| Phone |
9868226062 |
| Fax |
|
| Email |
khushbubarak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHTHA ARYA |
| Designation |
PROFESSOR |
| Affiliation |
SGT University |
| Address |
SGT Dental College Hospital and Research Institute Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9810761757 |
| Fax |
|
| Email |
drashthaarya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHTHA ARYA |
| Designation |
PROFESSOR |
| Affiliation |
SGT University |
| Address |
SGT Dental College Hospital and Research Institute Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9810761757 |
| Fax |
|
| Email |
drashthaarya@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SGT Dental College Hospital and Research Institute, Gurugram |
|
|
Primary Sponsor
|
| Name |
SGT UNIVERSITY |
| Address |
SGT Dental College Hospital and Research Institute, Gurugram |
| Type of Sponsor |
Research institution and hospital |
|
|
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 KHUSHBU |
SGT UNIVERSITY |
SGT Dental College
Hospital and Research
Institute, Gurugram,
HARYANA 122505
Gurgaon, HARYANA
Gurgaon
HARYANA |
9868226062
khushbubarak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT UNIVERSITY ETHICAL COMMITTEE |
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 |
Calcium hydroxide liner |
Selective removal of carious dentin will be done followed by placement of Calcium hydroxide to evaluate formation of reparative dentin at one year follow up. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Deeply carious tooth with proximity of lesion extending into pulpal third or quarter of the dentine as confirmed by the radiograph (score 4) |
|
| ExclusionCriteria |
| Details |
Immunocompromised patients. Association of periapical lesion or widening of periodontal space visible on radiograph. Presence of internal or external root resorption. Teeth with pulp exposure.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tooth is vital |
At 1year follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tooth is vital & asymptomatic |
At 1 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Will be published once the study is completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIM: Evaluation of the Efficacy of Indirect Pulp Therapy with Selective Removal of Carious Dentin in Permanent Teeth. OBJECTIVE: To evaluate the remineralization in permanent teeth with selective removal of carious dentin using calcium hydroxide as a liner and to access pulp vitality after selective removal of carious dentin in permanent teeth with deep carious lesion. METHODOLOGY: 100patients diagnosed with asymptomatic reversible pulpitis will be selected. Infected carious dentin will be removed using round diamond bur. After superficial necrotic dentin is removed, spoon excavator will be used for excavation of soft carious dentin. Infected dentin will be completely removed from lateral walls leaving thin layer of soft carious tissue over pulp to avoid exposure. A thin layer of calcium hydroxide liner will be applied on cavity floor followed by a base of colored composite. The cavity will be restored with composite resin. Clinical follow up examination for post op sensitivity, pain, tenderness, vitality and radiographic examination was performed at 1month,6months and 12months.Criteria for successful outcome involves formation of hard tissue, positive sensibility tests, no pain on percussion and no clinical or radiographical signs and symptoms of irreversible pulpitis |