Oral Health LiteracyNCT07327060
Intraoral Camera-Assisted Parent Training
A study testing Intraoral Camera-Assisted Oral Hygiene Education, Standard Verbal Oral Hygiene Education and Intraoral Photography of Permanent First Molars in people with Oral Health Literacy and Oral Health Care, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health Literacy, Oral Health Care, Intraoral Images
- What is being tested?
- Intraoral Camera-Assisted Oral Hygiene Education, Standard Verbal Oral Hygiene Education and Intraoral Photography of Permanent First Molars
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children with special healthcare needs, intellectual disabilities, or autism spectrum disorder
- Children with a Frankl Behavior Rating Scale score of 1 (Definitely negative)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydın Adnan Menderes University, Faculty of Dentistry
Aydin, 09100
Melis AKYILDIZ, 05387970703, baharmeliss@hotmail.com
Merve GÜNGÖR, 05416467511, mgungor@adu.edu.tr
About this study
Official title: Effect of Intraoral Camera-Assisted Parent Training on Children's Oral Hygiene and Parent Oral Health Literacy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Oral Health Literacy, Oral Health Care, Intraoral Images, Periodontal Index, Gingival Index, Caries
- Being tested
- 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), Parent and Child Satisfaction Survey
- Keywords
- Oral health literacy, Oral Health Care, İntraoral camera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral Camera-Assisted Oral Hygiene EducationBehavioural
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.
Standard Verbal Oral Hygiene EducationBehavioural
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.
Intraoral Photography of Permanent First MolarsDevice
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 study.
Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P)Behavioural
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.
Parent and Child Satisfaction SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Camera-Assisted Oral Hygiene Education | Experimental | In the intervention group, explanations provided during the oral examination will be visualized using an intraoral camera. After recording oral hygiene scores, a disclosing agent will be applied to the teeth. Following gentle rinsing and isolation, areas stained by plaque and not effectively cleaned will be highlighted, and brushing will be demonstrated accordingly. Using the Modified Stillman technique, the specific areas requiring toothbrush contact will be shown directly in the patient's mouth with intraoral camera visualization. Signs of gingival inflammation such as redness or swelling, as well as caries and plaque deposits, will also be displayed in real time. This approach individualizes the education, enabling both the child and parent to better understand and retain the oral hygiene instructions. Receives: Behavioral: Intraoral Camera-Assisted Oral Hygiene Education; Device: Intraoral Photography of Permanent First Molars; Behavioral: Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P); Other: Parent and Child Satisfaction Survey |
| Standard Verbal Oral Hygiene Education | Active comparator | Children in the control group undergo oral examination at the dental unit using a mirror and probe. Standard verbal oral hygiene education is provided to children and parents, including information on dental plaque, oral hygiene importance, and treatment needs. Brushing is demonstrated on a model using the Modified Stillman technique to ensure effective plaque control without harming the gingiva. For partially erupted permanent first molars, the "cross brushing" technique with horizontal bucco-lingual movements is also explained. Receives: Behavioral: Standard Verbal Oral Hygiene Education; Device: Intraoral Photography of Permanent First Molars; Behavioral: Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Plaque Index (PI)
Plaque levels on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, were assessed using the Silness and Löe Plaque Index (scores 0-3).
Plaque Index and Criteria:
0.Absence of microbial plaque
- Thin film of microbial plaque along the free gingival margin
- Moderate accumulation with plaque in the sulcus
- Large amount of plaque in sulcus or pocket along the free gingival margin
Measured: Baseline
Children's Plaque Index (PI)
Plaque levels on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, were assessed using the Silness and Löe Plaque Index (scores 0-3).
Plaque Index and Criteria:
- Absence of microbial plaque
- Thin film of microbial plaque along the free gingival margin
- Moderate accumulation with plaque in the sulcus
- Large amount of plaque in sulcus or pocket along the free gingival margin
Measured: 1 month after intervention
Children's Gingival Index (GI)
Gingival status was assessed on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, using the Löe and Silness Gingival Index (0-3).
Gingival Index (GI) and Criteria:
- Normal gingiva; no inflammation; no discoloration (erythema); no bleeding.
- Mild inflammation; slight erythema; minimal superficial alterations; no bleeding.
- Moderate inflammation; erythema; bleeding on probing.
- Severe inflammation; severe erythema and swelling; tendency to spontaneous bleeding; possible ulceration.
Measured: Baseline
Children's Gingival Index (GI)
Gingival status was assessed on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, using the Löe and Silness Gingival Index (0-3).
Gingival Index (GI) and Criteria:
- Normal gingiva; no inflammation; no discoloration (erythema); no bleeding.
- Mild inflammation; slight erythema; minimal superficial alterations; no bleeding.
- Moderate inflammation; erythema; bleeding on probing.
- Severe inflammation; severe erythema and swelling; tendency to spontaneous bleeding; possible ulceration.
Measured: 1 month after intervention
ICDAS Caries Score
Caries status of all present teeth, excluding partially erupted teeth, was recorded using the International Caries Detection and Assessment System (ICDAS).
ICDAS Codes (International Caries Detection and Assessment System)
- Sound tooth surface
- First visual change in enamel
- Distinct visual change in enamel
- Localized enamel breakdown due to caries with no visible dentin
- Underlying dark shadow from dentin (with or without enamel breakdown)
- Distinct cavity with visible dentin
- Extensive distinct cavity with visible dentin
Measured: Baseline
ICDAS Caries Score
Caries status of all present teeth, excluding partially erupted teeth, was recorded using the International Caries Detection and Assessment System (ICDAS).
ICDAS Codes (International Caries Detection and Assessment System)
- Sound tooth surface
- First visual change in enamel
- Distinct visual change in enamel
- Localized enamel breakdown due to caries with no visible dentin
- Underlying dark shadow from dentin (with or without enamel breakdown)
- Distinct cavity with visible dentin
- Extensive distinct cavity with visible dentin
Measured: 1 month after intervention
Parental Oral Health Literacy (TOHLAT-P)
Parents' oral health literacy, understanding of preventive care, and ability to support children's oral hygiene, assessed by TOHLAT-P.
This questionnaire is used to assess parents' oral health knowledge. It measures three types of knowledge (factual, procedural, and conceptual) and includes cognitive process levels (remembering, understanding, and analyzing). The tool also uses literacy and numeracy skills. It has three sections.
The maximum score for each section is 12, 26, and 14. The total score range is 0-52. Higher scores indicate higher oral health literacy.
Measured: Baseline
Parental Oral Health Literacy (TOHLAT-P)
Parents' oral health literacy, understanding of preventive care, and ability to support children's oral hygiene, assessed by TOHLAT-P.
This questionnaire is used to assess parents' oral health knowledge. It measures three types of knowledge (factual, procedural, and conceptual) and includes cognitive process levels (remembering, understanding, and analyzing). The tool also uses literacy and numeracy skills. It has three sections.
The maximum score for each section is 12, 26, and 14. The total score range is 0-52. Higher scores indicate higher oral health literacy.
Measured: 1 month after intervention
Secondary outcomes (3)
Occlusal Plaque Index (OPI)
Plaque accumulation on the occlusal surfaces of permanent first molars will be assessed after plaque disclosure using an intraoral camera. The images will be analyzed with ImageJ software (National Institutes of Health, USA) by manually outlining the total occlusal surface area and the plaque-covered areas. All measurements will be performed by the same examiner and repeated at two different time points to reduce measurement error. Intra-examiner reliability will be evaluated using the intraclass correlation coefficient (ICC), and the occlusal plaque index (OPI) will be calculated as the percentage of plaque-covered area relative to the total occlusal surface area using the formula: OPI = (Plaque area / Occlusal surface area) × 100.
Measured: Baseline
Occlusal Plaque Index (OPI)
Plaque accumulation on the occlusal surfaces of permanent first molars will be assessed after plaque disclosure using an intraoral camera. The images will be analyzed with ImageJ software (National Institutes of Health, USA) by manually outlining the total occlusal surface area and the plaque-covered areas. All measurements will be performed by the same examiner and repeated at two different time points to reduce measurement error. Intra-examiner reliability will be evaluated using the intraclass correlation coefficient (ICC), and the occlusal plaque index (OPI) will be calculated as the percentage of plaque-covered area relative to the total occlusal surface area using the formula: OPI = (Plaque area / Occlusal surface area) × 100.
Measured: 1 month after intervention
Parent and Child Satisfaction with Intraoral Camera-Assisted Education
In this study, children and parents will complete two short questionnaires to assess their perceptions of the use of an intraoral camera during dental examination. Responses will be recorded using a 5-point Likert-type scale ranging from strongly agree to strongly disagree, with higher scores indicating more positive perceptions of intraoral camera use.
Child questionnaire
- I liked having photographs of my teeth taken with the intraoral camera.
- I felt comfortable while photographs of my teeth were taken using the intraoral camera.
- I would tell my friends about having my teeth photographed with an intraoral camera.
Parent questionnaire
- The use of an intraoral camera helped us better understand dental treatment and oral hygiene instructions.
- The use of an intraoral camera improved our overall dental examination experience.
- I would recommend the use of an intraoral camera during dental examination to others.
Measured: At 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start5 Feb 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Oral Health LiteracyStudies 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
- Parallel groups
- Model description
- This study uses a randomized, controlled, parallel-group design. Participants are randomly assigned to the intervention or control group using computer-based block randomization through Random.Org (Randomness and Integrity Services Ltd., Ireland) to ensure fair and concealed allocation. Both groups are followed during the same period. Because the intervention is educational, blinding of participants and educators is not possible; however, outcome assessors are blinded to reduce bias. This design helps us evaluate whether intraoral camera-assisted education, in addition to standard oral hygiene instruction, improves children's oral health outcomes and increases parents' oral health literacy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis AKYILDIZ, Aydin Adnan Menderes University
- Investigators
- Melis AKYILDIZ, Principal investigator, Aydın Adnan Menderes University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327060
- Sponsor's protocol ID
- Mgungor
- Status last verified
- Sep 2025
- First submitted
- 25 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35851730Carvalho 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.
PubMed 37364559Duman, 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.
PubMed 27672245Khan AA. The permanent first molar as an indicator for predicting caries activity. Int Dent J. 1994 Dec;44(6):623-7.
PubMed 7851995LOE 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.
PubMed 14121956Murrell 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.
PubMed 31406005Nourallah 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.
PubMed 14767164Ozgul BM, Sakaryali D, Senirkentli GB, Tirali RE, Cehreli SB. Do really parents brush their children's teeth better? Eur J Paediatr Dent. 2019 Dec;20(4):325-329. doi: 10.23804/ejpd.2019.20.04.13.
PubMed 31850778Pentapati KC, Siddiq H. Clinical applications of intraoral camera to increase patient compliance - current perspectives. Clin Cosmet Investig Dent. 2019 Aug 23;11:267-278. doi: 10.2147/CCIDE.S192847. eCollection 2019.
PubMed 31692486Schiller C, Ho H, Sobue T, Katechia B, Tadinada A. Value of an Intraoral Camera in Evaluating Restorations and Plaque in a Simulated Environment: Observational Experiences of Dentists in Pediatric Contexts to Establish a Proof of Concept. Cureus. 2024 Oct 21;16(10):e72012. doi: 10.7759/cureus.72012. eCollection 2024 Oct.
PubMed 39569297Schulz-Weidner N, Gruber M, Schraml EM, Wostmann B, Kramer N, Schlenz MA. Improving the Communication of Dental Findings in Pediatric Dentistry by Using Intraoral Scans as a Visual Aid: A Randomized Clinical Trial. Dent J (Basel). 2024 Jan 17;12(1):15. doi: 10.3390/dj12010015.
PubMed 38248223Sharma S, Yeluri R, Jain AA, Munshi AK. Effect of toothbrush grip on plaque removal during manual toothbrushing in children. J Oral Sci. 2012;54(2):183-90. doi: 10.2334/josnusd.54.183.
PubMed 22790411SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PubMed 14158464Tan WK, Chua DR. Parental use and acceptance of an accessible, commercially available intraoral camera for teledentistry in their children. Eur Arch Paediatr Dent. 2024 Apr;25(2):237-246. doi: 10.1007/s40368-024-00878-7. Epub 2024 Apr 21.
PubMed 38643420
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoral Camera-Assisted Parent Training on Children's Oral Hygiene and Parent Oral Health Literacy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07327060
- Acronym / sponsor ID
- Mgungor
- Conditions
- Oral Health Literacy, Oral Health Care, Intraoral Images, Periodontal Index, Gingival Index, Caries
- Keywords
- Oral health literacy, Oral Health Care, İntraoral camera
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized, controlled, parallel-group design. Participants are randomly assigned to the intervention or control group using computer-based block randomization through Random.Org (Randomness and Integrity Services Ltd., Ireland) to ensure fair and concealed allocation. Both groups are followed during the same period. Because the intervention is educational, blinding of participants and educators is not possible; however, outcome assessors are blinded to reduce bias. This design helps us evaluate whether intraoral camera-assisted education, in addition to standard oral hygiene instruction, improves children's oral health outcomes and increases parents' oral health literacy.
| Arm | Type | Receives |
|---|---|---|
| Intraoral Camera-Assisted Oral Hygiene Education | Experimental | Behavioral: Intraoral Camera-Assisted Oral Hygiene Education, Device: Intraoral Photography of Permanent First Molars, Behavioral: Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P), Other: Parent and Child Satisfaction SurveyIn the intervention group, explanations provided during the oral examination will be visualized using an intraoral camera. After recording oral hygiene scores, a disclosing agent will be applied to the teeth. Following gentle rinsing and isolation, areas stained by plaque and not effectively cleaned will be highlighted, and brushing will be demonstrated accordingly. Using the Modified Stillman technique, the specific areas requiring toothbrush contact will be shown directly in the patient's mouth with intraoral camera visualization. Signs of gingival inflammation such as redness or swelling, as well as caries and plaque deposits, will also be displayed in real time. This approach individualizes the education, enabling both the child and parent to better understand and retain the oral hygiene instructions. |
| Standard Verbal Oral Hygiene Education | Active comparator | Behavioral: Standard Verbal Oral Hygiene Education, Device: Intraoral Photography of Permanent First Molars, Behavioral: Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P)Children in the control group undergo oral examination at the dental unit using a mirror and probe. Standard verbal oral hygiene education is provided to children and parents, including information on dental plaque, oral hygiene importance, and treatment needs. Brushing is demonstrated on a model using the Modified Stillman technique to ensure effective plaque control without harming the gingiva. For partially erupted permanent first molars, the "cross brushing" technique with horizontal bucco-lingual movements is also explained. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Children with special healthcare needs, intellectual disabilities, or autism spectrum disorder
- Children with a Frankl Behavior Rating Scale score of 1 (Definitely negative)
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 |
|---|---|---|
| Intraoral Camera-Assisted Oral Hygiene EducationParticipants 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. | Behavioural | Intraoral Camera-Assisted Oral Hygiene Education |
| Standard Verbal Oral Hygiene EducationParticipants 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. | Behavioural | Standard Verbal Oral Hygiene Education |
| Intraoral Photography of Permanent First MolarsOcclusal 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 study. | Device | Intraoral Camera-Assisted Oral Hygiene Education, Standard Verbal Oral Hygiene Education |
| 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. | Behavioural | Intraoral Camera-Assisted Oral Hygiene Education, Standard Verbal Oral Hygiene Education |
| Parent and Child Satisfaction SurveyA 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. | Other | Intraoral Camera-Assisted Oral Hygiene Education |
Primary outcome
Children's Plaque Index (PI)
Time frame: Baseline
Plaque levels on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, were assessed using the Silness and Löe Plaque Index (scores 0-3). Plaque Index and Criteria: 0.Absence of microbial plaque 1. Thin film of microbial plaque along the free gingival margin 2. Moderate accumulation with plaque in the sulcus 3. Large amount of plaque in sulcus or pocket along the free gingival margin
Children's Plaque Index (PI)
Time frame: 1 month after intervention
Plaque levels on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, were assessed using the Silness and Löe Plaque Index (scores 0-3). Plaque Index and Criteria: 0. Absence of microbial plaque 1. Thin film of microbial plaque along the free gingival margin 2. Moderate accumulation with plaque in the sulcus 3. Large amount of plaque in sulcus or pocket along the free gingival margin
Children's Gingival Index (GI)
Time frame: Baseline
Gingival status was assessed on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, using the Löe and Silness Gingival Index (0-3). Gingival Index (GI) and Criteria: 0. Normal gingiva; no inflammation; no discoloration (erythema); no bleeding. 1. Mild inflammation; slight erythema; minimal superficial alterations; no bleeding. 2. Moderate inflammation; erythema; bleeding on probing. 3. Severe inflammation; severe erythema and swelling; tendency to spontaneous bleeding; possible ulceration.
Children's Gingival Index (GI)
Time frame: 1 month after intervention
Gingival status was assessed on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, using the Löe and Silness Gingival Index (0-3). Gingival Index (GI) and Criteria: 0. Normal gingiva; no inflammation; no discoloration (erythema); no bleeding. 1. Mild inflammation; slight erythema; minimal superficial alterations; no bleeding. 2. Moderate inflammation; erythema; bleeding on probing. 3. Severe inflammation; severe erythema and swelling; tendency to spontaneous bleeding; possible ulceration.
ICDAS Caries Score
Time frame: Baseline
Caries status of all present teeth, excluding partially erupted teeth, was recorded using the International Caries Detection and Assessment System (ICDAS). ICDAS Codes (International Caries Detection and Assessment System) 0. Sound tooth surface 1. First visual change in enamel 2. Distinct visual change in enamel 3. Localized enamel breakdown due to caries with no visible dentin 4. Underlying dark shadow from dentin (with or without enamel breakdown) 5. Distinct cavity with visible dentin 6. Extensive distinct cavity with visible dentin
ICDAS Caries Score
Time frame: 1 month after intervention
Caries status of all present teeth, excluding partially erupted teeth, was recorded using the International Caries Detection and Assessment System (ICDAS). ICDAS Codes (International Caries Detection and Assessment System) 0. Sound tooth surface 1. First visual change in enamel 2. Distinct visual change in enamel 3. Localized enamel breakdown due to caries with no visible dentin 4. Underlying dark shadow from dentin (with or without enamel breakdown) 5. Distinct cavity with visible dentin 6. Extensive distinct cavity with visible dentin
Parental Oral Health Literacy (TOHLAT-P)
Time frame: Baseline
Parents' oral health literacy, understanding of preventive care, and ability to support children's oral hygiene, assessed by TOHLAT-P. This questionnaire is used to assess parents' oral health knowledge. It measures three types of knowledge (factual, procedural, and conceptual) and includes cognitive process levels (remembering, understanding, and analyzing). The tool also uses literacy and numeracy skills. It has three sections. The maximum score for each section is 12, 26, and 14. The total score range is 0-52. Higher scores indicate higher oral health literacy.
Parental Oral Health Literacy (TOHLAT-P)
Time frame: 1 month after intervention
Parents' oral health literacy, understanding of preventive care, and ability to support children's oral hygiene, assessed by TOHLAT-P. This questionnaire is used to assess parents' oral health knowledge. It measures three types of knowledge (factual, procedural, and conceptual) and includes cognitive process levels (remembering, understanding, and analyzing). The tool also uses literacy and numeracy skills. It has three sections. The maximum score for each section is 12, 26, and 14. The total score range is 0-52. Higher scores indicate higher oral health literacy.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 35851730Buldur 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.
- Background: PubMed 37364559Carvalho 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.
- BackgroundDuman, 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.
- Background: PubMed 27672245Gugnani 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.
- Background: PubMed 7851995Khan AA. The permanent first molar as an indicator for predicting caries activity. Int Dent J. 1994 Dec;44(6):623-7.
- Background: PubMed 14121956LOE 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.
- Background: PubMed 31406005Murrell 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.
- Background: PubMed 14767164Nourallah 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.
- Background: PubMed 31850778Ozgul BM, Sakaryali D, Senirkentli GB, Tirali RE, Cehreli SB. Do really parents brush their children's teeth better? Eur J Paediatr Dent. 2019 Dec;20(4):325-329. doi: 10.23804/ejpd.2019.20.04.13.
- Background: PubMed 31692486Pentapati KC, Siddiq H. Clinical applications of intraoral camera to increase patient compliance - current perspectives. Clin Cosmet Investig Dent. 2019 Aug 23;11:267-278. doi: 10.2147/CCIDE.S192847. eCollection 2019.
- Background: PubMed 39569297Schiller C, Ho H, Sobue T, Katechia B, Tadinada A. Value of an Intraoral Camera in Evaluating Restorations and Plaque in a Simulated Environment: Observational Experiences of Dentists in Pediatric Contexts to Establish a Proof of Concept. Cureus. 2024 Oct 21;16(10):e72012. doi: 10.7759/cureus.72012. eCollection 2024 Oct.
- Background: PubMed 38248223Schulz-Weidner N, Gruber M, Schraml EM, Wostmann B, Kramer N, Schlenz MA. Improving the Communication of Dental Findings in Pediatric Dentistry by Using Intraoral Scans as a Visual Aid: A Randomized Clinical Trial. Dent J (Basel). 2024 Jan 17;12(1):15. doi: 10.3390/dj12010015.
- This article introduces ICDAS, a standardized visual and clinical method for detecting and assessing dental caries from early to advanced stages, widely used in pediatric dentistry for accurate and early caries identification.Link provided by the sponsor.
- This study compared plaque removal efficacy of conventional and silicone toothbrushes in children aged 5-7, showing both methods were effective.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Melis AKYILDIZ principal investigator
Aydın Adnan Menderes University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral Camera-Assisted Oral Hygiene Education, Standard Verbal Oral Hygiene Education and Intraoral Photography of Permanent First Molars in people with Oral Health Literacy and Oral Health Care, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melis AKYILDIZ (05387970703, baharmeliss@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Plaque Index (PI) (time frame: Baseline). The study lists 8 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 NCT07327060, which also lists 18 linked publications.
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 9 Jan 2026.