Dental Caries in ChildrenNCT04923581
Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST).
A study testing Oral Health Behavioral Interventions in people with Dental Caries in Children and Early Childhood Caries, run by Merna Ihab at 2 sites in Egypt.
Trial summary
In the current study, MOST approach is proposed, to engineer an oral health behavior modification intervention, to increase the engagement of mothers in brushing their pre-school children's teeth. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Dental Caries in Children, Early Childhood Caries
- What is being tested?
- Oral Health Behavioral Interventions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesEgypt
- Study dates
- 8 Jul 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Mothers of children who are not willing to cooperate and show a definite negative behavior (Rating 1 Frankel's classification).
- Mothers of children who are physically disabled or medically compromised.
- Mothers of children in need of emergency dental treatments.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Alexandria University, Faculty of Dentistry
Alexandria
Department of Pediatric Dentistry and Dental Public Health, Alexandria University, Faculty of Dentistry
Alexandria
About this study
Official title: Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.
In the current study, MOST approach is proposed, to engineer an oral health behavior modification intervention, to increase the engagement of mothers in brushing their pre-school children's teeth.
Read the detailed description
The first phase of this study will be the preparation phase. This will comprise the development of a conceptual framework and conducting a feasibility pilot study consisting of three intervention components: Motivational interviewing (MI), Oral health promotion messages (OHPm), and Storytelling (ST). The second phase of the study is the optimization phase which constitutes a factorial trial of the three selected intervention components (MI, OHPm and ST). Each component will be set at two levels: yes (the intervention is applied) vs no (the intervention is not applied).
- Conditions
- Dental Caries in Children, Early Childhood Caries
- Being tested
- Oral Health Behavioral Interventions
- Keywords
- MOST, behavioural intervention, early childhood caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Behavioral InterventionsBehavioural
The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Participants will receive the constant component only. Receives: Behavioral: Oral Health Behavioral Interventions |
| Condition 2 | Experimental | Participants will receive the constant component and storytelling videos . Receives: Behavioral: Oral Health Behavioral Interventions |
| Condition 3 | Experimental | Participants will receive the constant component and oral health promotion messages. Receives: Behavioral: Oral Health Behavioral Interventions |
| Condition 4 | Experimental | Participants will receive the constant component, oral health promotion messages, and storytelling videos. Receives: Behavioral: Oral Health Behavioral Interventions |
| Condition 5 | Experimental | Participants will receive the constant component and motivational interview session. Receives: Behavioral: Oral Health Behavioral Interventions |
| Condition 6 | Experimental | Participants will receive the constant component, motivational interview session, and storytelling videos. Receives: Behavioral: Oral Health Behavioral Interventions |
| Condition 7 | Experimental | Participants will receive the constant component, motivational interview session, and oral health promotion messages. Receives: Behavioral: Oral Health Behavioral Interventions |
| Condition 8 | Experimental | Participants will receive the constant component, motivational interview session, oral health promotion messages and storytelling videos Receives: Behavioral: Oral Health Behavioral Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the plaque index scores of participating children
Measured by the Plaque index of Silness and Loe. Lower plaque scores indicate better oral hygiene
Measured: at baseline, 3 and 6 months
Change in children's frequency of toothbrushing and use of fluoridated toothpaste
Using the World Health Organization questionnaire. Highrr tooth brushing frequency indicates better oral hygiene
Measured: at baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start8 Jul 2023
- Primary completion30 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A factorial trial following the Multiphase optimization Strategy (MOST)
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merna Ihab
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Merna Ihab, Alexandria University
- Investigators
- Merna Ihab, B.Sc, Principal investigator, Alexandria University, Faculty of DentistryMaha El Tantawi, PhD, Study director, Alexandria University, Faculty of DentistryWafaa E. El Din, PhD, Study director, Alexandria University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923581
- Sponsor's protocol ID
- MOST2021
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2021
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ihab M, El Din WE, Ammar N, Yassin R, El Tantawi M. Using mHealth to promote parents' brushing of preschool children's teeth: a protocol for a randomized factorial trial using the Multi-phase Optimization Strategy (MOST). Trials. 2022 Jan 6;23(1):17. doi: 10.1186/s13063-021-05931-0.
PubMed 34991701
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.
- ClinicalTrials.gov ID
- NCT04923581
- Acronym / sponsor ID
- MOST2021
- Conditions
- Dental Caries in Children, Early Childhood Caries
- Keywords
- MOST, behavioural intervention, early childhood caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Merna IhabUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 8 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the current study, MOST approach is proposed, to engineer an oral health behavior modification intervention, to increase the engagement of mothers in brushing their pre-school children's teeth.
Detailed description
The first phase of this study will be the preparation phase. This will comprise the development of a conceptual framework and conducting a feasibility pilot study consisting of three intervention components: Motivational interviewing (MI), Oral health promotion messages (OHPm), and Storytelling (ST). The second phase of the study is the optimization phase which constitutes a factorial trial of the three selected intervention components (MI, OHPm and ST). Each component will be set at two levels: yes (the intervention is applied) vs no (the intervention is not applied).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- A factorial trial following the Multiphase optimization Strategy (MOST)
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Oral Health Behavioral InterventionsParticipants will receive the constant component only. |
| Condition 2 | Experimental | Behavioral: Oral Health Behavioral InterventionsParticipants will receive the constant component and storytelling videos . |
| Condition 3 | Experimental | Behavioral: Oral Health Behavioral InterventionsParticipants will receive the constant component and oral health promotion messages. |
| Condition 4 | Experimental | Behavioral: Oral Health Behavioral InterventionsParticipants will receive the constant component, oral health promotion messages, and storytelling videos. |
| Condition 5 | Experimental | Behavioral: Oral Health Behavioral InterventionsParticipants will receive the constant component and motivational interview session. |
| Condition 6 | Experimental | Behavioral: Oral Health Behavioral InterventionsParticipants will receive the constant component, motivational interview session, and storytelling videos. |
| Condition 7 | Experimental | Behavioral: Oral Health Behavioral InterventionsParticipants will receive the constant component, motivational interview session, and oral health promotion messages. |
| Condition 8 | Experimental | Behavioral: Oral Health Behavioral InterventionsParticipants will receive the constant component, motivational interview session, oral health promotion messages and storytelling videos |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Mothers of children who are not willing to cooperate and show a definite negative behavior (Rating 1 Frankel's classification).
- Mothers of children who are physically disabled or medically compromised.
- Mothers of children in need of emergency dental treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Health Behavioral InterventionsThe study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste. | Behavioural | Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8 |
Primary outcome
Change in the plaque index scores of participating children
Time frame: at baseline, 3 and 6 months
Measured by the Plaque index of Silness and Loe. Lower plaque scores indicate better oral hygiene
Change in children's frequency of toothbrushing and use of fluoridated toothpaste
Time frame: at baseline, 3 and 6 months
Using the World Health Organization questionnaire. Highrr tooth brushing frequency indicates better oral hygiene
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 34991701Ihab M, El Din WE, Ammar N, Yassin R, El Tantawi M. Using mHealth to promote parents' brushing of preschool children's teeth: a protocol for a randomized factorial trial using the Multi-phase Optimization Strategy (MOST). Trials. 2022 Jan 6;23(1):17. doi: 10.1186/s13063-021-05931-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merna Ihab, B.Sc principal investigator
Alexandria University, Faculty of Dentistry
Maha El Tantawi, PhD study director
Alexandria University, Faculty of Dentistry
Wafaa E. El Din, PhD study director
Alexandria University, Faculty of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health Behavioral Interventions in people with Dental Caries in Children and Early Childhood Caries, run by Merna Ihab at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the plaque index scores of participating children (time frame: at baseline, 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.