| CTRI Number |
CTRI/2021/09/036333 [Registered on: 08/09/2021] Trial Registered Prospectively |
| Last Modified On: |
04/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare quality of life before and after root canal treatment |
|
Scientific Title of Study
|
Oral health related quality of life and satisfaction outcomes of patients after nonsurgical endodontic therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Souparna Madhavan |
| Designation |
PhD Student |
| Affiliation |
Srinivas University |
| Address |
Srinivas Institute of Dental sciences
mukka
Mangalore
Dakshina Kannada
KARNATAKA
574146
India |
| Phone |
9535649469 |
| Fax |
|
| Email |
souparna1012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lavanya Varma |
| Designation |
Professor and Guide |
| Affiliation |
Srinivas University |
| Address |
Srinivas Institute of Dental sciences
mukka
Mangalore
Dakshina Kannada
KARNATAKA
574146
India |
| Phone |
9845315959 |
| Fax |
|
| Email |
lavanyavarma77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Souparna Madhavan |
| Designation |
PhD Student |
| Affiliation |
Srinivas Institute Of Dental Sciences |
| Address |
Srinivas Institute of Dental sciences
mukka
Mangalore
Dakshina Kannada
KARNATAKA
574146
India |
| Phone |
9535649469 |
| Fax |
|
| Email |
souparna1012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Srinivas Institute of Dental Sciences
Mukka
Magalore |
|
|
Primary Sponsor
|
| Name |
Dr Souparna Madhavan |
| Address |
Srinivas Institute Dental sciences
Mukka
Mangalore |
| 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 Souparna Madhavan |
Srinivas Institute of Dental Sciences |
Department of Conservative Dentistry & Endodontics, Room No 3
Dakshina Kannada
KARNATAKA |
9535649469
souparna1012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients requiring root canal treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AHPlus and Endomethasone |
AH plus is a resin based root canal sealer used for obturations of root canal.
Endomethasone is a corticosteroid Medicated root canal sealer used for obturations of root canal
Here the efficiency of these root canal sealers will be recorded and will be compared |
| Comparator Agent |
Zinc oxide eugenol |
Zinc oxide eugenol is Rootcanal sealer used during root canal treatment. It is Commonly used sealer and hence will be used as a control agent . The efficiency of this sealer will be recorded.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Clinical cases with periapical conditions |
|
| ExclusionCriteria |
| Details |
1.Any serious medical condition/hospitalization.
2.Pediatric age group.
3.Any kind of physical or psychological disability.
4.Any case of poor prognosis especially periodontally weak teeth.
5.Patient not providing consent .
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life and patient satisfaction before and after endodontic treatment |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficiency of rooot canal sealers |
One Year |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2021 |
| Date of Study Completion (India) |
01/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral health related quality of
life and satisfaction outcomes of patients after Endodontic therapy is a
Randomized Clinical trial recruiting 180 patients. Primary outcome is to
measure the quality of life and patient satisfaction before and after
Endodontic therapy. Secondary outcome will be the efficiency of the root canal
sealers used in the root canal treatment
|