Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-12
Brief Title:
An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children
Sponsor:
Ziauddin University
Organization:
Ziauddin University
Study Overview
Official Title:
A Feasibility Study of the Investigation on the Efficacy of Oral Health Education for Mothers OHEM Module for Improving Oral Hygiene in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study evaluates the feasibility of conducting a larger Randomized Controlled Trial to compare three oral health education delivery methods to a control group Except for the control group mothers in the three intervention groups will receive the same oral health education based on the OHEM module but differ in the delivery methods namely lecture exhibition and demonstration All groups will receive a booklet and oral hygiene kits and be instructed to educate their children at home Pre- and post-intervention assessments include the satisfaction of participants the researchers evaluation and cost of the trial oral hygiene status and the knowledge of the parents and children
Detailed Description:
Research question
There is lacking evidence that oral health education via family-based intervention is effective in improving oral hygiene in children
OHEM
A manual the Oral Health Educational Module OHEM has been developed for oral health educators planning a family-based intervention to improve oral health in children by educating and empowering the mothers OHEM aims to educate mothers about oral health and guide them to share the knowledge with their children The content includes basic oral health knowledge and the description for preparing and delivering intervention and comes with instruments for assessing the understanding of mothers and children Educators can choose to carry out the intervention using OHEM via three delivery methods either in a lecture exhibition andor demonstration and each will present the same educational messages
Objectives
General objective To investigate the feasibility of conducting a larger RCT for comparing the efficacy of the OHEM module delivered via lecture exhibition and demonstration to a control group
Primary objective
1 To determine the satisfaction of participants with the intervention program using 10 item questions relating to the organisation researchers attitude recruitment process of trial intervention process OHEM content and delivery method OHEM sessions arrangement and venue screening process and fruitfulness of research among families
2 To assess the recruitment and participation of the participants in the study
3 To determine the cost of the trial
Secondary objectives are
4 To assess changes in the outcomes of the trial after the intervention in mothers and children i Dental plaque status ii Gingival status iii Oral health knowledge attitudes and practices iv Oral health behaviors tooth brushing and dental flossing skills v Oral health-related quality of life using OHIP-14
Methods
Study design This is a randomized controlled trial feasibility study comparing four groups Lecture Exhibition Demonstration and Control
Study location Ziauddin University Primary Health Care Center Union Council Gulshan-e-Sikandarabad Kemari Karachi Pakistan The area of Gulshan-e-Sikandarabad comprises five housing blocks
Sample The study participants will include mother-child dyads the intervention is provided to the mothers and the outcomes will be assessed in the mothers and children
Sample size The main study assumed that children in the intervention groups would have 66 times greater odds of improving their gingival status one level better than before the intervention compared to the control group Using the Open Epi sample size calculator the sample size needed for assessing the efficacy of OHEM is n 112 per group based on 80 power and 5 significant level and n 135 per group after accounting for a 20 loss to follow-up N 540 The present feasibility study will recruit 30 of the sample which is 41 dyad pairs per group or 164 dyad pairs in four groups
Sampling technique A stratified randomized sampling method to select the participants It will randomly select i four of five residential blocks and then ii five streets from each block Each block will be randomly assigned to one of the intervention or control groups
The systematic random sampling technique every second household will be used to select a household with a mother-child dyad from each street
Data collection
1 Approach and explain to mothers at each identified household assess the suitability based on the inclusion and exclusion criteria and obtain consent
2 Carry out baseline assessments on mothers and children Participants will be asked to complete the questionnaires and undergo oral screening for dental plaque and gingivitis as well as assessment for behavioral skills tooth brushing and dental flossing skills They will be given an appointment to attend the respective intervention programs which will be carried out on separate days
3 Mothers in the intervention groups will receive the allocated intervention a booklet including a summary of oral health information and an oral hygiene kit with toothbrushes family-size toothpaste mouthwash solution and dental floss They will be instructed to educate their children about oral health knowledge
The control group will receive only the booklet without any instruction and an oral hygiene kit The participants will be asked not to share the details of the intervention with other participants or individuals known to be involved in the study
4 The mothers and children will be asked to attend the post-intervention assessment after three months in which they will complete the questionnaires and undergo clinical and behavioral skill assessment
Only one examiner dentist will carry out the clinical and behavioral assessments and will be blinded to the intervention group assignment
Instrument and tools The following tools will be used to collect the data from the mother-child dyad
i Feasibility assessment measures
1 Satisfaction of participants
2 Recruitment and participation of the participants in the study
3 Cost of the trial
ii Dental plaque index using Silness and Loe criteria at pre- and post-intervention
iii Gingival index using Loe and Silness criteria at pre- and post-intervention
iii OHEM-KAP Knowledge attitude practices Questionnaire for mothers and children at pre- and post-intervention
iv Tooth brushing and Dental flossing skills checklist at pre- and post-intervention
v OHIP-14 Oral health impact profile - 14 Questionnaire at pre- and post-intervention
Intervention The intervention will deliver the same knowledge content and use the same materials but the latter can be in different forms according to the delivery method For example pictures of tooth anatomy will be used in all three delivery methods a toothbrush will be shown as a picture in the lecture and the real product will be presented in the exhibition and demonstration and toothbrushing practice will be presented as picturesvideos in the lecture and exhibition and a live demo during the demonstration
OHEM-L The lecture is a live talk by an educator aided by Power Point slides based on OHEM and delivered to a group of 20 participantssession for 30- to 40 minutes with no QA sessions
OHEM-E The exhibition is a display of educational posters and real exhibits based on OHEM The participants will be given instructions to carry out self-learning by observing and reading the information The participants will view the exhibits as they arrive but with some crowd control The exhibition session would take 30-40 minutes to complete with no explanation by an educator and no QA at the end of the session
OHEM-D The demonstration is a live presentation by an educator with the aid of posters actual products and tooth models and a live demo of toothbrushing dental flossing and mouth rinsing techniques based on OHEM The demonstration will be delivered to a group of n10 participants session for 30 - 40 minutes without a QA session
All participants in the intervention groups will be instructed to teach their children what they have learned with the help of the booklet Participants will also be taught how to teach their children
Control This group will not receive any intervention However they will be provided with an oral health education booklet without instructions to teach their children at home and an oral hygiene kit
There will be no specific Q A session for all groups However to keep the trial pragmatic and encourage a knowledge-seeking attitude among the mothers the educator will respond to the queries if participants have any and including facilitating with hands-on practice
There is lacking evidence that oral health education via family-based intervention is effective in improving oral hygiene in children
OHEM
A manual the Oral Health Educational Module OHEM has been developed for oral health educators planning a family-based intervention to improve oral health in children by educating and empowering the mothers OHEM aims to educate mothers about oral health and guide them to share the knowledge with their children The content includes basic oral health knowledge and the description for preparing and delivering intervention and comes with instruments for assessing the understanding of mothers and children Educators can choose to carry out the intervention using OHEM via three delivery methods either in a lecture exhibition andor demonstration and each will present the same educational messages
Objectives
General objective To investigate the feasibility of conducting a larger RCT for comparing the efficacy of the OHEM module delivered via lecture exhibition and demonstration to a control group
Primary objective
1 To determine the satisfaction of participants with the intervention program using 10 item questions relating to the organisation researchers attitude recruitment process of trial intervention process OHEM content and delivery method OHEM sessions arrangement and venue screening process and fruitfulness of research among families
2 To assess the recruitment and participation of the participants in the study
3 To determine the cost of the trial
Secondary objectives are
4 To assess changes in the outcomes of the trial after the intervention in mothers and children i Dental plaque status ii Gingival status iii Oral health knowledge attitudes and practices iv Oral health behaviors tooth brushing and dental flossing skills v Oral health-related quality of life using OHIP-14
Methods
Study design This is a randomized controlled trial feasibility study comparing four groups Lecture Exhibition Demonstration and Control
Study location Ziauddin University Primary Health Care Center Union Council Gulshan-e-Sikandarabad Kemari Karachi Pakistan The area of Gulshan-e-Sikandarabad comprises five housing blocks
Sample The study participants will include mother-child dyads the intervention is provided to the mothers and the outcomes will be assessed in the mothers and children
Sample size The main study assumed that children in the intervention groups would have 66 times greater odds of improving their gingival status one level better than before the intervention compared to the control group Using the Open Epi sample size calculator the sample size needed for assessing the efficacy of OHEM is n 112 per group based on 80 power and 5 significant level and n 135 per group after accounting for a 20 loss to follow-up N 540 The present feasibility study will recruit 30 of the sample which is 41 dyad pairs per group or 164 dyad pairs in four groups
Sampling technique A stratified randomized sampling method to select the participants It will randomly select i four of five residential blocks and then ii five streets from each block Each block will be randomly assigned to one of the intervention or control groups
The systematic random sampling technique every second household will be used to select a household with a mother-child dyad from each street
Data collection
1 Approach and explain to mothers at each identified household assess the suitability based on the inclusion and exclusion criteria and obtain consent
2 Carry out baseline assessments on mothers and children Participants will be asked to complete the questionnaires and undergo oral screening for dental plaque and gingivitis as well as assessment for behavioral skills tooth brushing and dental flossing skills They will be given an appointment to attend the respective intervention programs which will be carried out on separate days
3 Mothers in the intervention groups will receive the allocated intervention a booklet including a summary of oral health information and an oral hygiene kit with toothbrushes family-size toothpaste mouthwash solution and dental floss They will be instructed to educate their children about oral health knowledge
The control group will receive only the booklet without any instruction and an oral hygiene kit The participants will be asked not to share the details of the intervention with other participants or individuals known to be involved in the study
4 The mothers and children will be asked to attend the post-intervention assessment after three months in which they will complete the questionnaires and undergo clinical and behavioral skill assessment
Only one examiner dentist will carry out the clinical and behavioral assessments and will be blinded to the intervention group assignment
Instrument and tools The following tools will be used to collect the data from the mother-child dyad
i Feasibility assessment measures
1 Satisfaction of participants
2 Recruitment and participation of the participants in the study
3 Cost of the trial
ii Dental plaque index using Silness and Loe criteria at pre- and post-intervention
iii Gingival index using Loe and Silness criteria at pre- and post-intervention
iii OHEM-KAP Knowledge attitude practices Questionnaire for mothers and children at pre- and post-intervention
iv Tooth brushing and Dental flossing skills checklist at pre- and post-intervention
v OHIP-14 Oral health impact profile - 14 Questionnaire at pre- and post-intervention
Intervention The intervention will deliver the same knowledge content and use the same materials but the latter can be in different forms according to the delivery method For example pictures of tooth anatomy will be used in all three delivery methods a toothbrush will be shown as a picture in the lecture and the real product will be presented in the exhibition and demonstration and toothbrushing practice will be presented as picturesvideos in the lecture and exhibition and a live demo during the demonstration
OHEM-L The lecture is a live talk by an educator aided by Power Point slides based on OHEM and delivered to a group of 20 participantssession for 30- to 40 minutes with no QA sessions
OHEM-E The exhibition is a display of educational posters and real exhibits based on OHEM The participants will be given instructions to carry out self-learning by observing and reading the information The participants will view the exhibits as they arrive but with some crowd control The exhibition session would take 30-40 minutes to complete with no explanation by an educator and no QA at the end of the session
OHEM-D The demonstration is a live presentation by an educator with the aid of posters actual products and tooth models and a live demo of toothbrushing dental flossing and mouth rinsing techniques based on OHEM The demonstration will be delivered to a group of n10 participants session for 30 - 40 minutes without a QA session
All participants in the intervention groups will be instructed to teach their children what they have learned with the help of the booklet Participants will also be taught how to teach their children
Control This group will not receive any intervention However they will be provided with an oral health education booklet without instructions to teach their children at home and an oral hygiene kit
There will be no specific Q A session for all groups However to keep the trial pragmatic and encourage a knowledge-seeking attitude among the mothers the educator will respond to the queries if participants have any and including facilitating with hands-on practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None