| CTRI Number |
CTRI/2024/04/065782 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Oral health knowledge and practice] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Oral Health Training on Primary Health Care Workers in Gandaki province of Nepal
|
|
Scientific Title of Study
|
Impact of Oral Health Training on Primary Health Care Workers in Gandaki province of Nepal: A pilot study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Subedi |
| Designation |
Lecturer |
| Affiliation |
|
| Address |
Department of Community Dentistry, room no 8, College of Dental Surgery, Gandaki Medical College Teaching Hospital and Research Center, Pokhara, Nepal
33700
Other |
| Phone |
9779842172496 |
| Fax |
|
| Email |
drkrishnasubedimdsphd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Subedi |
| Designation |
Lecturer |
| Affiliation |
|
| Address |
Department of Community Dentistry, room no 8, College of Dental Surgery, Gandaki Medical College Teaching Hospital and Research Center, Pokhara, Nepal
33700
Other |
| Phone |
9779842172496 |
| Fax |
|
| Email |
drkrishnasubedimdsphd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Subedi |
| Designation |
Lecturer |
| Affiliation |
|
| Address |
Department of Community Dentistry, room no 8, College of Dental Surgery, Gandaki Medical College Teaching Hospital and Research Center, Pokhara, Nepal
33700
Other |
| Phone |
9779842172496 |
| Fax |
|
| Email |
drkrishnasubedimdsphd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pokhara Training Center, Pokhara ,Nepal |
|
|
Primary Sponsor
|
| Name |
Pokhara Training Center |
| Address |
Pokhara Training Center, Pokhara, Nepal. Pin code:33700 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Subedi |
Health Training Center Pokhara Nepal |
Health training division, Hall 1,Health Training Center Pokhara Nepal
|
977-9842172496
drkrishnasubedimdsphd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gandaki Medical College- Institutional Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health workers like Health assistants (HA) and Community medicine assistants (CMA) attending the Oral Health training |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
As this is single group intervention study where oral health training will be provided and their knowledge and oral hygiene practices will be measured after training. Therefore there is no other comparator agent. |
| Intervention |
Oral health training |
Oral health training included topics like oral anatomy, specialization in dentistry, dental caries and its sequelae, teeth hypersensitivity, dentoalveolar abscess, space infection, fluoride, fluoride varnish and its application, gingivitis and periodontitis, brushing and flossing methods, common oral lesion, tobacco and oral cancer, systemic disease and trigeminal neuralgia, common pediatric problem, eruption disorder, traumatic problems, malocclusion, TMJ dislocation, role of diet on oral health. Various dental experts (recommended by the training center) will provide training to the participants in the above-mentioned topics for six (6) days in Baisakh 2081. The method of training will be using a PowerPoint presentation, different tooth models and brushing models, diagnostic instruments (mouth mirror, explorer, a pair of tweezers), fluoride varnish, and videos. The training will be provided by the Health Training Center Pokhara Nepal. The duration of training will be for 6 days. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
All the participants who will present during the training session and provide written informed consent |
|
| ExclusionCriteria |
| Details |
Incomplete responses will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improve in knowledge of oral health among primary health care workers |
data collection 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve in practice of oral health among primary health according to work experience |
data collection 1 month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="0"
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 4 |
|
Date of First Enrollment (India)
|
27/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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 - NO
|
|
Brief Summary
|
Oral diseases encompass a range of diseases and conditions that include dental caries, periodontal (gum) disease, tooth loss, oral cancer, oro-dental trauma, noma, and birth defects such as cleft lip and palate. There is no dental manpower in the primary health care services (Health posts) in Nepal. People residing in rural areas also have the right to have good oral health. For this reason, those manpower who are available in the health post should be trained regarding oral health so that the basic prevention strategies can be employed at the primary level. Before complete implementation of any program, it should be evaluated. Therefore this study will assess the impact of oral health training on primary health care workers in Gandaki Province, Nepal. The training will be provided by the Health Training Center Pokhara Nepal. Various dental experts (recommended by the training center) will provide training to the participants in the above-mentioned topics for six (6) days in April 2024. The method of training will be using a PowerPoint presentation, different tooth models and brushing models, and video. There are a total of 30 questions for assessing oral health knowledge and 8 questions for oral health practices which will be filled by the participants. Data obtained will be entered in Microsoft Excel Sheet version 2013 and analyzed using R 4.3.2 software. The level of significance will be set at p˂0.05. Shapiro–Wilk test will be used to check the normality of the data. |