| CTRI Number |
CTRI/2023/03/050176 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EVALUATION OF ORAL HEALTH VIDEOS AS A MEDIUM OF EDUCATION IN PATIENTS WITH GUM DISEASE |
|
Scientific Title of Study
|
EVALUATION OF AUDIO-VISUAL AIDS AS A MEDIUM OF PERIODONTAL HEALTH EDUCATION FOR PATIENTS WITH PERIODONTITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sidra Raza |
| Designation |
Post graduate student |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences |
| Address |
Department of periodontics, KAHER KLE Institute of dental sciences, Nehru Nagar, Belagavi - 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7970896048 |
| Fax |
|
| Email |
sidraraza96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Menaka KB |
| Designation |
Professor |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences |
| Address |
Department of periodontics, KAHER KLE Institute of dental sciences, Nehru Nagar, Belagavi - 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9448268812 |
| Fax |
|
| Email |
menakakaralwad@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Sidra Raza |
| Designation |
Post graduate student |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences |
| Address |
Department of periodontics, KAHER KLE Institute of dental sciences, Nehru Nagar, Belagavi - 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7970896048 |
| Fax |
|
| Email |
sidraraza96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics, KLE VK Institute Of Dental Sciences, Nehru Nagar, Belagavi - 590010, Karnataka |
|
|
Primary Sponsor
|
| Name |
Sidra Raza |
| Address |
Department of periodontics, KAHER KLE Institute of dental sciences, Nehru Nagar, Belgaum - 590010 |
| 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 |
| Sidra Raza |
KLE VK Institute of Dental Sciences |
Room number 9, Department of Periodontics, KLE VK institute of dental sciences , Nehru Nagar, Belagavi - 590010
Belgaum
KARNATAKA |
07970896048
sidraraza96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethics committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Periodontal health education in the form of Audio-visual aids |
Periodontal health education in the form of Audio-visual aids using videos and computer based animations.
Frequency : Once ,
Duration : 10 minutes |
| Comparator Agent |
Periodontal health education in the form of standard education |
Periodontal health education in the form of standard education through oral narration.
Frequency : Once ,
Duration : 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
- Patients who are willing to give consent.
- All adults in the age group of 35- 44 years (according to WHO index age group).
- Having at least one periodontal pocket of 5 mm or more. |
|
| ExclusionCriteria |
| Details |
-No previous periodontal treatment.
-Individuals with any kind medical conditions where memory loss could occur. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The mean of correct answers will be assessed.
|
Baseline and 1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of subjects answering correctly |
Baseline and after receiving education |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patient education is an important aspect of dentistry to motivate individuals for undergoing any procedure. in order for the patients to make any treatment decisions, they must be provided with pertinent information in a manner that promotes understanding.
Usually this information is imparted through verbal discussion with the clinician. Evidence suggests that patients often do not understand what is being said to them during a dental encounter due to cultural, language and educational gaps between the clinician and patients. this often discourages the patients to undergo any treatment.
The use of audio-visual aids is advocated to bridge this gap between the patients and clinicians to promote understanding of their clinical condition. Various audio-visual aids such as video-films and 3D model animations can be used to impart oral health related knowledge to outpatient department patients. Therefore, this study is undertaken with an aim to evaluate audio-visual aids as a medium of periodontal health education for patients with periodontitis |