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Recruiting NCT07327060

Intraoral Camera-Assisted Parent Training

No phase Interventional Oral Health Literacy Oral Health Care Intraoral Images Periodontal Index

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoral Camera-Assisted Oral Hygiene Education, Standard Verbal Oral Hygiene Education, Intraoral Photography of Permanent First Molars, Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P).
Who it may be relevant to
Registry conditions: Oral Health Literacy, Oral Health Care, Intraoral Images, Periodontal Index. Basic parameters: 5 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Intraoral Camera-Assisted Parent Training on Children's Oral Hygiene and Parent Oral Health Literacy: A Randomized Controlled Trial

Overview

The aim of this randomized controlled trial is to test the null hypothesis that parent education using an intraoral camera has no effect on children's oral hygiene levels, parental oral health literacy, or plaque accumulation on first permanent molars compared with standard verbal education. 40 children aged 5-7 and their parents will be randomly assigned to two groups. The intervention group will receive real-time visualization of dental conditions and brushing techniques using an intraoral camera, while the control group will receive standard verbal education using a brushing model. Outcomes include children's plaque and gum health and ICDAS caries scores. Secondary outcomes include Occlusal Plaque Index (OPI) on first molars. Assessments will be conducted at baseline and 1-month follow-up. This study tests whether intraoral camera-assisted education leads to better oral hygiene outcomes in children, improves parents' oral health literacy, and reduces plaque accumulation on the first permanent molars compared to standard verbal education.

Detailed description

Dental caries is a common problem in children, and teaching good oral hygiene is important for prevention. Parents play a key role in protecting their children's teeth, especially when the first permanent molars erupt, because these teeth are more sensitive to plaque and caries. In pediatric dentistry, it is known that when parents have better oral health literacy, their children tend to show better oral health outcomes, making parental literacy an important factor.

Because of this, education methods that allow parents and children to see the mouth clearly may be more effective. Using an intraoral camera provides real-time visual feedback, so children and parents can directly observe plaque, caries, and brushing mistakes. This may increase motivation, support correct brushing techniques, and improve parents' understanding of oral health.

The aim of this study is to determine whether intraoral camera-assisted education can improve children's oral hygiene and increase parents' oral health awareness and literacy more than standard verbal education.

Based on this aim, the study tested the following hypotheses:

Null Hypothesis (H0a): Intraoral camera-assisted education has no effect on improving children's oral hygiene levels.

Alternative Hypothesis (H1a): Intraoral camera-assisted education improves children's oral hygiene levels.

Null Hypothesis (H0b): Intraoral camera-assisted education has no effect on improving parental oral health literacy.

Alternative Hypothesis (H1b): Intraoral camera-assisted education improves parental oral health literacy.

Null Hypothesis (H0c): Intraoral camera-assisted education has no effect on plaque accumulation on first permanent molars.

Alternative Hypothesis (H1c): Intraoral camera-assisted education reduces plaque accumulation on first permanent molars.

For this purpose, the study is planned as a randomized controlled trial with two groups: an intervention group and a control group. Data will be collected before the education and at the 1-month follow-up after the education to compare changes over time. A two-factor repeated measures ANOVA will be used to evaluate the differences between the groups.

A priori power analysis (G\*Power 3.1) showed that at least 34 participants (17 for each group) are needed to detect a medium effect (f = 0.25, α = 0.05, 80% power). To reduce the risk of sample loss, a total of 40 child-parent pairs will be included. These pairs will be randomly assigned to either the intraoral camera-assisted education group or the standard verbal education group.

Intervention group: Receives intraoral camera-assisted oral hygiene education. Dental findings such as plaque, caries, and gingival inflammation, as well as brushing techniques, are visualized in real time. Disclosing agents highlight plaque-covered areas, and brushing demonstrations on the child's teeth are individualized using the Modified Stillman and cross-brushing techniques. Parents and children receive visual feedback to reinforce oral hygiene education.

Control group: Receives standard verbal oral hygiene education using a brushing model. The Modified Stillman and cross-brushing techniques are demonstrated verbally and on the model, without intraoral camera visualization.

Primary outcomes are changes in children's Plaque Index (PI), Gingival Index (GI), ICDAS caries scores, and parents' oral health literacy assessed using the Turkish version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P).

Secondary outcomes are the Occlusal Plaque Index (OPI) on first molars and the Parent-Child Satisfaction Survey evaluating the intraoral camera-assisted education. Assessments will be conducted at baseline and 1-month follow-up, except for the satisfaction survey, which will be administered only at the 1-month follow-up. The study assesses whether visualized instruction provides additional benefits over verbal education alone in improving objective clinical measures and parental understanding, supporting enhanced preventive care in pediatric dental practice.

Interventions

  • Behavioral Intraoral Camera-Assisted Oral Hygiene Education
    Participants receive individualized oral hygiene education using an intraoral camera. Dental findings such as plaque, caries, and gingival inflammation are visualized in real time. Disclosing agents highlight plaque-covered areas, and brushing demonstrations are performed directly on the child's teeth using the Modified Stillman and cross-brushing techniques. Parents and children receive visual feedback to reinforce proper oral hygiene practices.
  • Behavioral Standard Verbal Oral Hygiene Education
    Participants receive standard verbal oral hygiene education using a brushing model. The Modified Stillman and cross-brushing techniques are demonstrated verbally and on the model. Oral hygiene principles, plaque control, and the importance of regular brushing are explained to both children and parents.
  • Device Intraoral Photography of Permanent First Molars
    Occlusal surfaces of permanent first molars will be photographed using the EZCAM VATECH intraoral camera to document plaque accumulation. The photographs will be shown only to participants in the camera-assisted education group during oral hygiene instruction. These images will help them see plaque areas and understand correct brushing. The control group will receive only verbal education and will not view the photographs. All images will be stored securely and used only for evaluation in the st
  • Behavioral Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P)
    Parental oral health literacy, knowledge about preventive dental care, and their ability to help their child with oral hygiene will be measured using the Turkish version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P). This tool evaluates parents' understanding and use of oral health information. Higher scores indicate better oral health literacy.
  • Other Parent and Child Satisfaction Survey
    A structured questionnaire was given to children and parents in the intraoral camera education group. The aim was to evaluate their satisfaction with the education process. The questionnaire focused on the usability of the intraoral camera and how helpful it was during dental education.

Primary outcome measures

  • Children's Plaque Index (PI) [Time frame: Baseline]
  • Children's Plaque Index (PI) [Time frame: 1 month after intervention]
  • Children's Gingival Index (GI) [Time frame: Baseline]
  • Children's Gingival Index (GI) [Time frame: 1 month after intervention]
  • ICDAS Caries Score [Time frame: Baseline]
  • ICDAS Caries Score [Time frame: 1 month after intervention]
  • Parental Oral Health Literacy (TOHLAT-P) [Time frame: Baseline]
  • Parental Oral Health Literacy (TOHLAT-P) [Time frame: 1 month after intervention]
Secondary outcome measures (3)
  • Occlusal Plaque Index (OPI) [Time frame: Baseline]
  • Occlusal Plaque Index (OPI) [Time frame: 1 month after intervention]
  • Parent and Child Satisfaction with Intraoral Camera-Assisted Education [Time frame: At 1 month after intervention]

Eligibility criteria

Inclusion criteria

  • Systemically healthy children
  • Age between 5-7 years, with at least one first permanent molar in the eruption stage
  • No urgent treatment needs (e.g., dental trauma or pain)
  • Voluntary participation with signed and verbal informed consent from parents, and willingness to attend follow-up visits regularly

Exclusion criteria

  • Children with special healthcare needs, intellectual disabilities, or autism spectrum disorder
  • Children with a Frankl Behavior Rating Scale score of 1 (Definitely negative)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Aydın Adnan Menderes University, Faculty of Dentistry — Aydin

Publications

  • Buldur B, Oguz E. Reliability and validity of the Turkish version of the Oral Health Literacy Assessment Task: Pathways between parental oral health literacy and oral health consequences in children. Int J Paediatr Dent. 2023 Mar;33(2):101-112. doi: 10.1111/ipd.13025. Epub 2022 Jul 26. PMID 35851730
  • Carvalho JC. Chapter 9.2: Non-Operative Treatment of Coronal Caries. Monogr Oral Sci. 2023;31:149-171. doi: 10.1159/000530589. Epub 2023 Jun 26. PMID 37364559
  • Duman, S., & Duruk, G. (2018). 6-12 Yaş Grubu Çocuklarda Daimi Birinci Büyük Azı Dişlerin Önemi ve Değerlendirilmesi - Derleme. Atatürk Üniversitesi Diş Hekimliği Fakültesi Dergisi, 28(4), 610-624.
  • Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15. PMID 27672245
  • Khan AA. The permanent first molar as an indicator for predicting caries activity. Int Dent J. 1994 Dec;44(6):623-7. PMID 7851995
  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available. PMID 14121956
  • Murrell M, Marchini L, Blanchette D, Ashida S. Intraoral Camera Use in a Dental School Clinic: Evaluations by Faculty, Students, and Patients. J Dent Educ. 2019 Nov;83(11):1339-1344. doi: 10.21815/JDE.019.140. Epub 2019 Aug 12. PMID 31406005
  • Nourallah AW, Splieth CH. Efficacy of occlusal plaque removal in erupting molars: a comparison of an electric toothbrush and the cross-toothbrushing technique. Caries Res. 2004 Mar-Apr;38(2):91-4. doi: 10.1159/000075931. PMID 14767164

Identifiers

NCT: NCT07327060 · Mgungor

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗