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The goal of this clinical trial is to evaluate the effectiveness of an eco-friendly toothbrush compared to a conventional nylon-based toothbrush on cariogram parameters in children and adults. It will also assess the impact of toothbrush type on caries risk factors. The main questions it aims to answer are:
Does the use of an eco-friendly toothbrush improve cariogram parameters compared to a nylon-based toothbrush? Does toothbrush type influence overall caries risk in children and adults?
Participants will:
This study is a randomized controlled clinical trial designed to compare the effects of an eco-friendly toothbrush and a conventional nylon-based toothbrush on cariogram parameters in children and adults. Eligible participants will be classified by age group and randomly allocated into two intervention groups. At baseline, all participants will undergo clinical examination and caries risk assessment using the Cariogram model. Standardized oral hygiene instructions will be provided to all participants. Participants in each group will use the assigned toothbrush exclusively throughout the study period.
Follow-up assessments will be conducted at predetermined intervals to evaluate changes in cariogram parameters. Compliance with toothbrush use will be monitored during follow-up visits.
The primary outcome is the change in cariogram parameters from baseline to the end of the study period. Secondary outcomes include differences in overall caries risk profile between the two toothbrush groups and between age categories. Data will be analyzed to compare the effects of toothbrush type on cariogram outcomes while accounting for age-related differences
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children age group | Experimental | children will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used |
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| Adults age group | Experimental | Adults will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nylon based tooth brush | Other | nylon based tooth brush will be used by children and adults age groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caries risk profile determined by cariogram | it determines if the patient is high, moderate and low caries risk after the study | 6 months follow up |
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Inclusion Criteria:
This age group is specifically chosen due to the prevalence of mixed dentition, which presents unique challenges and considerations for oral hygiene practices and assessment, and is considered as being a high caries risk profile according to the cariogram parameters. (Tavargeri & Banerjee, 2021)(Lodha, Saraf, & Jawdekar, 2023) Adults' age Group: Participants must be within the age range of 18 to 35 years consider as being a high caries risk profile according to the cariogram parameters.
(AlDhawi et al., 2020; Fageeh et al., 2024) and (Fouad et al., 2022)
Exclusion Criteria:
For the children's age group:
For the adult group:
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| Name | Affiliation | Role |
|---|---|---|
| Raneen Ahmed Gohar, Lecturer | Lecturer at Department of Operative Dentistry, Faculty of Dentistry, Suez University, P.O. Box:43221, Suez, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Suez university | Suez | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fouad, H., Elzoghbi, A., Mosallam, R., & Abouauf, E. (2022). Effectiveness of different preventive regimens on Cariogram parameters of high caries risk patients: A randomized controlled trial. Journal of International Oral Health, 14(2), 128. doi:10.4103/jioh.jioh_316_21 |
| Label | URL |
|---|---|
| the ecofriendly toothbrush | View source |
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Individual participant data (IPD) will not be shared for the protection of participant confidentiality.
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| Ecofriendly toothbrush | Other | Children and adults group will use ecofriendly tooth brush |
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