| CTRI Number |
CTRI/2024/07/069928 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to verify the efficacy of usage of audio-visual aids versus traditional pamphlets for promotion of oral hygiene in student population |
|
Scientific Title of Study
|
Enhancing oral hygiene retention. A randomized controlled trial on the efficacy of dynamic multimedia tools versus traditional leaflets |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P M Durga Shiva Prasad |
| Designation |
PG Student |
| Affiliation |
Sri Sai College of Dental Surgery |
| Address |
Room No 3, Department of Periodontics, 1-2-64/1 and 2, Kothrepally, Opp. Shiv Sagar lake, Vikarabad
Hyderabad
TELANGANA
501102
India |
| Phone |
9989045568 |
| Fax |
|
| Email |
shivaprasad.durga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Murali Krishna |
| Designation |
Professor |
| Affiliation |
Sri Sai College of Dental Surgery |
| Address |
Room No 3, Department of Periodontics, 1-2-64/1 and 2, Kothrepally, Opp. Shiv Sagar lake, Vikarabad
Hyderabad
TELANGANA
501102
India |
| Phone |
9701340795 |
| Fax |
|
| Email |
muralimds1752@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P M Durga Shiva Prasad |
| Designation |
PG Student |
| Affiliation |
Sri Sai College of Dental Surgery |
| Address |
Room No 3, Department of Periodontics, 1-2-64/1 and 2, Kothrepally, Opp. Shiv Sagar lake, Vikarabad
Hyderabad
TELANGANA
501102
India |
| Phone |
9989045568 |
| Fax |
|
| Email |
shivaprasad.durga@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
P M Durga Shiva Prasad |
| Address |
1-2-64/1 and 2, Kothrepally, Opp. Shiv Sagar lake, Vikarabad, Telangana-501102 |
| 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 |
| P M Durga Shiva Prasad |
Sri Sai College of Dental Surgery |
Department of Periodontics, Room No 3, 1-2-64/1 and 2, Kothrepally, Opp. Shiv Sagar lake, Vikarabad
Hyderabad
TELANGANA |
9989045568
shivaprasad.durga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sai College of Dental surgery Institutional Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Audio-Visual Aid |
A video of the MODIFIED BASS BRUSHING TECHNIQUE will be sent to the patient via Whatsapp or e-mail once every week for 8 weeks |
| Comparator Agent |
Brushing model |
MODIFIED BASS BRUSHING TECHNIQUE will be explained to the subject on a chairside dental model. |
| Intervention |
Leaflet |
A Leaflet consisting of MODIFIED BASS BRUSHING TECHNIQUE will be given to the subject at baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
100 systemically healthy subjects aged about 18 to 25 years studying in a Dental college suffering with mild marginal gingivitis will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects suffering with Periodontitis
2. Subjects on any antibiotic medication or mouthwash.
3. Subjects who are not willing to take part in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quigley Hein Plaque Index |
Baseline and 8 weeks postmotivation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient declared behavioural change questionnaire |
Baseline and 8 weeks postmotivation |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivaprasad.durga@gmail.com].
- For how long will this data be available start date provided 08-07-2024 and end date provided 09-07-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
INTRODUCTION: Oral hygiene is of paramount importance for the preservation of oral health. Several clinical frameworks have been developed to foster behaviour change, such as motivational interviewing. However, two obstacles can be identified. Firstly, the sustainability of Oral Hygiene Education (OHE), which the patients receive during the consultation. Secondly, reinforcement over a period of time is difficult, thus leading to relapse. AIMS and OBJECTIVE: To compare E-learning of oral hygiene to traditional oral hygiene education. The full mouth plaque scores of study groups at baseline and 8 weeks of follow-up. To assess the psychological compliance of the subject to the dentist at 8 weeks of follow-up. MATERIALS and METHODS: 100 systemically healthy subjects aged between 18-25 years were recruited after fulfilling the inclusion and exclusion criteria and then randomized into 4 groups. 1: Subjects educated using audio-visual aid only 2: Subjects educated using the pamphlet method only 3: Subjects educated using both audio-visual aid and pamphlet method 4: Subjects educated at the time of dental visit only Clinical parameters i.e., Plaque assessment (Quigley Hein plaque index) was evaluated at baseline and 8 weeks at follow-up followed by a questionnaire to assess the psychological component. |