| CTRI Number |
CTRI/2025/04/085860 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
An in vivo study on the evaluation of vital pulp therapy using different materials in permanent teeth with irreversible pulpitis. |
|
Scientific Title of Study
|
Evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis using different materials an in vivo study |
| 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 RAGINI KULKARNI |
| Designation |
POST GRADUATE STUDENTS |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHMEDABAD |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS GOVT DENTAL COLLEGE AND HOSPITAL , CIVIL HOSP CAMPUS ASARWA AHMEDABAD GUJARAT 380016
Department of conservative dentistry and endodontics, govt dental
college and hospital, civil hospital campus, asarwa,ahmedabad.
Ahmadabad GUJARAT India
512, C-block, Dental pg girls hostel, Govt Dental College and
hospital, Civil Hospital Campus, asarwa, Ahmedabad, 380016
Gandhinagar
GUJARAT
380016
India
Ahmadabad
GUJARAT
380016
India |
| Phone |
7350950834 |
| Fax |
|
| Email |
raginikulkarni2271999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GEETA ASTHANA |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHMEDABAD |
| Address |
Department of conservative dentistry and endodontics , government dental college and hospital , civil hospital campus , Asarwa , Ahmedabad , Gujarat 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824440656 |
| Fax |
|
| Email |
geetasthana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GEETA ASTHANA |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHMEDABAD |
| Address |
Department of conservative dentistry and endodontics , government dental college and hospital , civil hospital campus , Asarwa , Ahmedabad , Gujarat 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824440656 |
| Fax |
|
| Email |
geetasthana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics , government dental college and hospital , civil hospital campus , asarwa , Ahmedabad , Gujarat 380016 |
|
|
Primary Sponsor
|
| Name |
Government Dental College and hospital Ahmedabad |
| Address |
Department of conservative dentistry and endodontics , government dental college and hospital , civil hospital campus , asarwa , Ahmedabad , Gujarat 380016 |
| Type of Sponsor |
Other [GOVERNMENT DENTAL 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 Ragini Kulkarni |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHMEDABAD |
Department of conservative dentistry and endodontics , Government dental college and hospital, Civil hospital campus, Ahmedabad , Gujarat 380016
Ahmadabad
GUJARAT |
7350950834
raginikulkarni2271999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHMEDABAD |
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 |
pulpotomy in permanent teeth with symptomatic irreversible pulpitis with hemostasis achieved using 2.5 percent sodium hypochlorite |
After isolation of tooth and LA full pulpotomy will be performed with high speed round bur , hemostasis will be achieved with 2.5 percent of sodium hypochlorite and after that mineral trioxide aggregate or mta putty will be placed then glass ionomer cement and final restoration. Duration for this intervention will be 6 months and 1 year |
| Comparator Agent |
pulpotomy in permanent teeth with symptomatic irreversible pulpitis with hemostasis achieved using 3 percent chitosan solution . |
Caries will be excavated using high speed handpiece and round bur after giving local anesthesia then coronal full pulpotomy will be done using high speed handpiece and hemostasis will be achieved using 3 percent chitosan solution followed by either mineral trioxide aggregate or putty the glass ionomer cement and final restoration with composite . Duration for the study will be 6 months and 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient should be more than 18 years old
Permanent teeth with deep carious lesion
Tooth giving positive response to cold testing or ept and diagnosed as irreversible pulpitis .
No signs of pulpal necrosis including swelling and sinus tract .
The tooth should be restorable with normal probing depth.
|
|
| ExclusionCriteria |
| Details |
Moderate or severe marginal periodontitis
Non restorable teeth , presence of sinus tract or swelling .
Active systemic disease ( asa ii, iii,iv,v )
Negative response to cold test and ept .
Pregnant and nursing women .
Absence of bleeding from any canals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Absence of pain and discomfort except during the first week after treatment
Normal mobility of the tooth
|
1 week , 6 months , 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No pathosis present on radiovisiography |
6 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/05/2025 |
| 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 Yet Recruiting |
| 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
|
AIM :TO EVALUATE THE EFFICACY OF CHITOSAN AND
SODIUM HYPOCHLORITE AS HEMOSTATIC AGENTS IN REDUCING POST OPERATIVE PAIN AND TO
ASSESS SEALING ABILITY AND HEALING OUTCOMES OF DIFFERENT MEDICAMENTS IN CASES
OF IRREVERSIBLE PULPITIS UNDERGOING PULPOTOMY PROCEDURE IN PERMANENT TEETH .
OBJECTIVES:
•To
evaluate and compare efficacy of chitosan and sodium hypochlorite as
haemostatic agents in reducing post operative pain following pulpotomy in
permanent teeth with irreversible pulpitis.
•To
evaluate overall success rate and complications ( if any ) associated with the
use of chitosan and sodium hypochlorite as haemostatic agents in pulpotomy
procedures for irreversible pulpitis.
•To
compare sealing ability of MTA and Neoputty as pulpotomy medicaments and to evaluate
the clinical and radiographic outcomes of permanent teeth following pulpotomy
procedure . CLINICAL SUCCESS CRITERIA
Postoperative pain incidence will be
noted on the basis of visual analogue scale.
•Absence
of pain and discomfort except during the first week after treatment
•Normal
mobility of the tooth
•No
tenderness to percussion
•Normal
soft tissues around the tooth with no swelling or sinus tract RADIOGRAPHIC SUCCESS CRITERIA
A baseline postoperative periapical
radiograph will be obtained using radiovisiography
which will be used during comparative evaluation at 6
months and 12 months .No
pathosis evident on the radiograph such as root resorption , furcal pathosis or
periapical pathosis. |