| CTRI Number |
CTRI/2025/12/098914 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the improvement in quality of life and pain reduction in patients with painful decayed teeth treated with pulpotomy. |
|
Scientific Title of Study
|
Assessment of change in quality of life after coronal pulpotomy in patients with symptomatic irreversible pulpitis – A Prospective Observational 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 |
Mridula Parameswaran |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College Trivandrum |
| Address |
Department of Conservative Dentistry and Endodontics Government Dental College Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8921617649 |
| Fax |
|
| Email |
mridulatdc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mridula Parameswaran |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College Trivandrum |
| Address |
Department of Conservative Dentistry and Endodontics Government Dental College Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8921617649 |
| Fax |
|
| Email |
mridulatdc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mridula Parameswaran |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College Trivandrum |
| Address |
Department of Conservative Dentistry and Endodontics Government Dental College Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8921617649 |
| Fax |
|
| Email |
mridulatdc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mridula Parameswaran |
| Address |
Assistant Professor Department of Conservative dentistry and Endodontics, Government Dental College Trivandrum |
| 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 Mridula Parameswaran |
Government Dental College Trivandrum |
Department of Conservative Dentistry and Endodontics Government Dental College Trivandrum
Thiruvananthapuram
KERALA |
08921617649
mridulatdc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Goverment Dental College Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A491||Streptococcal infection, unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
not applicable |
| Comparator Agent |
nil |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Mature permanent teeth diagnosed with symptomatic irreversible pulpitis as per AAE Criteria
Peri Apical Index (PAI)=1
Positive response to cold and electric pulp tests
Spontaneous /nocturnal /referred and /or lingering pain
Teeth with restorable carious lesions |
|
| ExclusionCriteria |
| Details |
Immature roots, cracks, cusp fractures, subgingival caries.
Poor periodontal health
History of sinus tract or swelling Not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of the oral health related quality of life and general health related quality of life after coronal pulpotomy assessed preoperatively (Day 0) and at 7,14 and 21 days postoperatively using the modified Oral Health Index Profile questionnaire (OHIP -17) and EQ-5D-5L questionnaire.
|
assessed at day 0 day7 14 and 21 days following pulpotomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of pain level after coronal pulpotomy assessed at 1,3,5 and 7 days postoperatively as compared to Day 0 using Numerical Rating Scale (NRS)
|
Assessed at day 1 3 5 and 7 days following pulpotomy |
| Assessment of any association between postoperative quality of life and preoperative variables like preoperative pain level, periapical status, amount of bleeding encountered, and time taken for hemostasis in relation to the involved tooth. |
assessed at day 0 day7 14 and 21 days following pulpotomy |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
01/01/2026 |
| 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="0"
Months="6"
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
|
This prospective observational clinical study aims to assess the postoperative oral health related quality of life and the general health related quality of life following coronal pulpotomy in patients with painful decayed teeth . the quality of life shall be assessed at day 7th 14th and 21st days following this treatment by the principal invesigator using an interviewer administered questionnare in regional language by contacting the patient via telephone .There are few studies focused on patient-reported outcomes, with a majority focused upon
clinician-reported outcomes of pulpotomy. Hence this study aims to assess the patient reported
outcome on the postoperative quality of life in general as well as the oral health related quality
of life following coronal pulpotomy in patients diagnosed with symptomatic irreversible
pulpitis. The results of this study would help in corelating the preoperative condition of the
painful tooth with the postoperative wellbeing of the patient following coronal pulpotomy and
could ultimately enable the clinician to choose the most appropriate treatment plan for the
symptomatic tooth. |