| CTRI Number |
CTRI/2024/06/068431 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Oral Health-Related Quality of Life in Patients Needing Root Canal Treatment. |
|
Scientific Title of Study
|
Oral Health-Related Quality of Life and associated factors in patients requiring endodontic treatment. |
| 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 Jishnu Pradeep |
| Designation |
Post-Graduate Student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8848177180 |
| Fax |
|
| Email |
drjishnupradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Kalyana Chakravarthy |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9916036303 |
| Fax |
|
| Email |
kalyan.cp@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jishnu Pradeep |
| Designation |
Post-Graduate Student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8848177180 |
| Fax |
|
| Email |
drjishnupradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| MCODS, Room no 8, Department of Public Health Dentistry,
Manipal College of Dental Science, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr JISHNU PRADEEP |
| Address |
Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 JISHNU PRADEEP |
Dr. T.M.A Pai Hospital , Udupi |
Dental O.P.D, 1st Floor, Dr. T.M.A Pai Hospital , Court Rd, opp. Old Taluk Office, Brahmagiri, Udupi, Karnataka 576101
Udupi
KARNATAKA |
8848177180
drjishnupradeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, (3) ICD-10 Condition: K045||Chronic apical periodontitis, (4) ICD-10 Condition: K046||Periapical abscess with sinus, (5) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
A) Patients willing to participate.
B) Patients aged between 18 and 45 years of age.
C) Patients requiring endodontic treatment. |
|
| ExclusionCriteria |
| Details |
A) Patients with acute condition who requires immediate treatment.
B) Patients who find it difficult to communicate.
C) Large periapical cysts and those require a surgical approach.
D) Patients who require re-endodontic treatment.
E) Those who have co-morbidities such as diabetes, hypertension, bleeding disorders,
respiratory diseases, liver diseases, etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral Health Related Quality of Life |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Periapical score and Community Periodontal Index and Loss of Attachment |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="413"
Sample Size from India="413"
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)
|
15/06/2024 |
| 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="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
|
In dentistry, the need for endodontic treatment has been assessed based on symptoms such as pain, swelling, or sensitivity with minimal focus on the implications on the patient’s daily activities. It is important to measure the impact of oral health issues on the individual Oral Health-related Quality of Life (OHRQoL). Oral Health Impact Profile (OHIP-14) is one such tool that co-relates seven aspects of life that are affected by a disease and how a person perceives the changes. Patients who visit the OPD of TMA Pai Hospital who require endodontic treatment will be invited to participate in the study. After the consent, the patient will be selected based on the inclusion and exclusion criteria. A self-administered questionnaire in Kannada would be used to gather information on demographics (age, sex, education, occupation, and monthly income). the patient’s current pain will be evaluated with the help of a Visual analogue scale for pain assessment (VAS). The Oral Health-related Quality of Life (OHRQoL) will be measured with the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaire will also consist of two global self-rated questions that assess the general and oral health status from the patient’s perspective. A trained and calibrated dentist will conduct a clinical examination which includes the assessment of caries using decayed, missing, and filled teeth index. The periodontal status will be assessed with Community Periodontal Index and Loss of Attachment as per WHO criteria (2013). The Periapical score (PAI indices) will be recorded using intra-oral radiographs (X-rays taken as part of the standard of care for root canal treatment. Normality of the data will be tested and the mean OHIP-14 scores will be compared with categorical variables based on the distribution of data. Significant predictors will be used for multi-variate analysis to calculate the point estimates. Outcome measures: Oral Health Impact Profile (OHIP-14) Benefits: Assessing the impact of various factors on oral health-related quality of life at an individual as well as at the community level. Risks: Minor increase over minimal risk or Low risk. |