| CTRI Number |
CTRI/2024/07/070831 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Patient Satisfaction with Comprehensive Dental Care in Public Health Dentistry. |
|
Scientific Title of Study
|
Assessment of patient satisfaction considering Comprehensive Dental Care
model in Public Health Dentistry.
|
| 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 Chinmay Devanand Surlakar |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College Of Dental Sciences And Hospital, Dharwad |
| Address |
Department Of Public Health Dentistry, SDM College Of Dental Sciences And Hospital,
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7588279919 |
| Fax |
|
| Email |
chinmay4151@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chinmay Devanand Surlakar |
| Designation |
Post graduate student |
| Affiliation |
SDM College Of Dental Sciences And Hospital, Dharwad |
| Address |
Department Of Public Health Dentistry, SDM College Of Dental Sciences And Hospital,
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7588279919 |
| Fax |
|
| Email |
chinmay4151@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha J Shetty |
| Designation |
Professor, Department of Public Health Dentistry |
| Affiliation |
SDM College Of Dental Sciences And Hospital, Dharwad |
| Address |
Department Of Public Health Dentistry, SDM College Of Dental Sciences And Hospital,
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9845009979 |
| Fax |
|
| Email |
shetty.preetha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College Of Dental Sciences And Hospital,Dharwad, India
580009
|
|
|
Primary Sponsor
|
| Name |
Dr Chinmay Devanand Surlakar |
| Address |
Department of Public Health Dentistry, SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL,
DHARWAD
|
| 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 Chinmay Devanand Surlakar |
SDM College Of Dental Sciences And Hospital, Dharwad |
Department Of Public Health Dentistry, SDM College Of Dental Sciences And Hospital,
Dharwad
Dharwad
KARNATAKA |
7588279919
chinmay4151@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF DENTAL SCIENCED AND HOSPITAL INSTITUTIONAL EHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive dental care model. |
Description: Based on different phases of treatment (Phase 1: emergency phase. Phase 2: Preventive phase. Phase 3: Promotive
phase. Phase 4: Curative phase.
Phase 5: Rehabilitation phase. Phase 6: Maintenance phase), the patient will receive care for all of their treatment needs by the same assigned dentist over a period of time. Referrals to specialty department, if required, will be done and followed up by same dentist.
|
| Comparator Agent |
Traditional dental care model |
patient treatment needs will be addressed by multiple dentists over the period of time. The referrals to specialty department if required will be followed by different dentist. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Two or more treatments need.
2. Possess a mobile phone
3. Patients available throughout the study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women.
2. Patients with Physical or mental disability
3. Patients with uncontrolled non- communicable diseases.
4. Patients with communicable diseases
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of patient satisfaction: service element attribute according to kano two-dimensional quality model (must-be, attractive, one-dimensional, indifferent, and reverse attributes). To determine whether there is a difference in patient satisfaction after receiving treatment from either treatment model, the mean patient satisfaction scores for each model will be taken into account.
The service elements are identified based on structure-process-outcome model to evaluate healthcare service quality, developed by Donabedian.
This approach can help identify the key determinants of patient satisfaction
with dental services.
|
Post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction coefficient: Positive (better) and Negative (worse) numbers.
The range of absolute values of the PS coefficients is 0 to 1; values close to 1 are associated with stronger influences on patient satisfaction or dissatisfaction.
Patient requirements can be ranked using the patient satisfaction (PS) coefficient, which shows how much a service element influences satisfaction or dissatisfaction.
|
Post intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/08/2024 |
| 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="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 study is randomized parallel group assessing patient satisfaction when treatment is given through comprehensive dental care model. The patients are allotted to two treatment groups: comprehensive and traditional treatment models. This study utilises a questionnaire based on a kano-type questionnaire to understand patient perception and satisfaction after getting treatment according to a comprehensive care model. The outcome will be patient satisfaction for service elements based on structure, process, outcome as specified by Donabedian for quality healthcare. This can enable us to prioritize and allocate resources to service elements that can influence patient satisfaction in comprehensive dental care model and a traditional model. By comparing these two models, we can also determine whether implementing a comprehensive dental care model in the department of public health dentistry would be more effective in delivering quality dental care. This information can be utilized for developing protocols and guidelines for providing quality oral care. |