跳至主要内容
临床试验/NCT07327060
NCT07327060招募中不适用

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

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Children's Plaque Index (PI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

For both children and parents, the intraoral camera-assisted education or verbal instruction will be applied clearly within each group, and parents will be informed about the procedures and the study plan. To increase the scientific validity and reliability of the results, oral examinations and data collection will be done by different people. In this way, the assessors will stay blinded to the participants' group allocation during all evaluations, ensuring that the data collected are objective. The same blinding will be used for the Occlusal Plaque Index (OPI) assessment, so the examiner will evaluate plaque on first permanent molars without knowing whether the child received intraoral camera-assisted education or standard verbal instruction.

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Intraoral Camera-Assisted Oral Hygiene Education (Behavioral)

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.

干预措施: Intraoral Photography of Permanent First Molars (Device)

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.

干预措施: Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P) (Behavioral)

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.

干预措施: Parent and Child Satisfaction Survey (Other)

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.

干预措施: Standard Verbal Oral Hygiene Education (Behavioral)

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.

干预措施: Intraoral Photography of Permanent First Molars (Device)

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.

干预措施: Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P) (Behavioral)

结局指标

主要结局

Children's Plaque Index (PI)

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 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.

Children's Plaque Index (PI)

时间窗: 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 Gingival Index (GI)

时间窗: 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.

ICDAS Caries Score

时间窗: 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

Parental Oral Health Literacy (TOHLAT-P)

时间窗: 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.

次要结局

  • Parent and Child Satisfaction with Intraoral Camera-Assisted Education(At 1 month after intervention)
  • Occlusal Plaque Index (OPI)(1 month after intervention)
  • Occlusal Plaque Index (OPI)(Baseline)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melis AKYILDIZ

assistant prof

Aydin Adnan Menderes University

研究点 (2)

Loading locations...

相似试验