| CTRI Number |
CTRI/2021/10/037349 [Registered on: 18/10/2021] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of maintaining oral health by giving instructions manual and digital aids. |
|
Scientific Title of Study
|
Effectiveness of maintaining gingival health by displaying oral hygiene instructions by digital and manual means |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prerna Tandon |
| Designation |
PG Student |
| Affiliation |
Institute of Dental Sciences |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of Dental Sciences Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9927940278 |
| Fax |
|
| Email |
tandonprerna0010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R G Shiva Manjunath |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Dental Sciences |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of Dental Sciences Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8126644491 |
| Fax |
|
| Email |
drmanju75@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rika Singh |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of Dental Sciences Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
rikasingh22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Sciences, Near Suresh Sharma Nagar, Pilibhit bypass road, Bareilly-243006 |
|
|
Primary Sponsor
|
| Name |
Dr Prerna Tandon |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of Dental Sciences Bareilly |
| 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 R G Shiva Manjunath |
Institue of dental sciences |
Room No 228, Department of Periodontology and Implantology
Bareilly
UTTAR PRADESH |
8126644491
drmanju75@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioural changes on the basis of digital means |
VISUAL AIDS – Patient would be explained on how to maintain oral hygiene, post treatment by video graphic presentation in patient own vernacular language. |
| Comparator Agent |
Behavioural chnages on the basis of manual means |
MANUAL MEANS - Patient would be explained by verbal method demonstrated on models. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with chronic generalized gingivitis. |
|
| ExclusionCriteria |
| Details |
Patients with xerostomia, pregnancy, smoking, diabetes, psychomotor disturbance
Patients on anti- inflammatory and antibiotic use within 3 months
Patients wearing any kind of dental appliance, ortho- fixtures and those diagnosed with periodontitis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of oral hygiene maintenance instructed through digital and manual aids |
baseline, 15 days, 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the oral hygiene maintenance after giving post operative instructions by digital method.
To evaluate the oral hygiene maintenance after giving post operative instructions by manual method.
To compare the oral hygiene maintenance when instructed through digital and manual methods after giving post operative instructions.
|
baseline, 15 days, 30 days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/10/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Even though video instructional formats have been shown to be effective in teaching mentally challenged subjects oral hygiene skills, even when using manual tooth brushes, multimedia software implementation in a computerized teaching format has not been thoroughly studied. Hence, with this consideration, this study compares the effectiveness of manual and digital oral hygiene maintenance instructed through digital and manual aids. |