This cross-sectional study recruited Saudi children between the ages of 7–12 years of age and the parents of these children. Parents will include individuals who attend the IAU Dental Hospital between September 2022-February 2023.
Sample Size
Sample size calculation was done. A power calculation was performed using Stata/SE16.1 (StataCorp, College Station, TX, USA). Assuming that the difference in OHRQoL among anxious children compared to non-anxious children would differ by a mean score of 19. (1) A sample size of N = 58 is adequate to obtain a type 1 error rate of 5% and a power of 80%. However, we believe this number to be too low. So, we decided that we will be using a convenience sample based on children who attend the clinic between September 2022-February 2023. We were able to collect a sample size of 93.
The inclusion criteria involved Saudi children; Arabic-speaking parents; children between the ages of 7–12 years; and good health. The exclusion criteria are non-Saudi children; non-Arabic speaking parents; children with special care needs or children with a debilitating medical condition. and refusal to give consent for enrolment in the study.
Questionnaire assessment
Informed consent
was obtained from parents as a part of our online questionnaire that asked questions related to the child's oral health-related quality of life. The questionnaire involves the Arabic-validated questionnaire of the COHIP-SF19 and the Arabic-validated questionnaire of the CFSS-DS. Further, parents' questionnaire form was used from a previous study including 5 questions involving the child’s age, parent’s age, income, education level, and smoking status was added to the survey. (1)(10)
Clinical examination
Participants' weight will be measured using a calibrated digital scale, height will be measured using a stadiometer. Clinical examination will be conducted using a sharp explorer, and a dental mirror. The oral examination will record Angle’s molar classification, presence of crossbite, presence of an open-bite, midline shift, and decayed teeth. Oral exam will be conducted by two examiners and inter-reliability testing will be performed.
Defining Outcomes, Exposures, and Confounders
OHRQoL: This was measured and analyzed as a count variable using the COHIP-SF 19.
Children’s Dental Anxiety: Was measured using the CFSS-DS and analyzed as a count variable and as a binary variable (CFSS-DS ≥ 38; high anxiety). (20)
Parent’s fear of dentists: Measured using a 5-point Likert Scale. However, it was analyzed as a continuous variable.
Parent’s previous bad experience: Measured as a binary variable where they answered “yes/no” to “if they had ever had a previous bad experience with a dentist when they were a child.”
Parent’s comfort at the last visit to the dentist: Measured as a binary variable where they answered, “comfortable/anxious”.
Caries Percentage: Percentage of caries was calculated as the number of carious primary and permanent teeth divided by the total number of primary and permanent teeth.
Child’s age: Was measured as a continuous variable.
Child’s sex: Was measured as a binary variable (male/female).
Education: Was measured as a categorical variable (less than high school; high school; more than high school).
Family Income: Was measured as a categorical variable (low: <9,000 Saudi Riyals (SAR); medium: 9,000-12000 SAR; high > 12,000 SAR) (21).
Parental Smoking: Was measured as a categorical variable (never smoked; former smokers; current smokers) (22).
Child’s Weight Category: Measured as a categorical variable. Calculated using the World Health Organization (WHO) criteria. Underweight: BMI is less than or equal to -2; Normal: BMI is greater than − 2 and less than 1; Overweight: BMI is greater than or equal to 1 and less than 2; Obese: BMI is greater than or equal to 2. (23)
Ethical Considerations
The research ethical approval (IRB-2022-02-379) was obtained from the Deanship of Scientific Research, Imam Abdulrahman Bin Faisal University, Dammam. Participation in the study was voluntary, and they were ensured of anonymity, privacy, and confidentiality of their data. The purpose, details, and expected benefits of the study were explained to all participants. Ethical guidelines expressed in the Declaration of Helsinki were followed during the conduct of the study.
Statistical Analysis
Descriptive statistics (means and standard deviations) were reported. Unpaired t-tests were used to compare the difference in means among the two groups. One-way analysis of variance (ANOVA) was used to analyze differences in means among three or more groups. A univariate negative binomial regression analysis was used to study the association between COHIP-SF 19 and age; COHIP-SF 19 and caries percentage; CFSS-DS and age; CFSS-DS and caries percentage. Parental fear of dentists was measured using a 5-point Likert scale and was analyzed as a continuous variable. When CFSS-DS was used as a count outcome a negative binomial regression analysis was conducted. However, when CFSS-DS was used as a binary outcome, a logistic regression analysis was done. We performed an adjusted negative binomial regression analysis to examine the association between OHRQoL (COHIP-SF19) and children’s dental anxiety (CFSS-DS). An adjusted negative binomial regression analysis was used to examine the association between children’s dental anxiety (CFSS-DS) and parental anxiety (parent's fear of dentists; parent’s previous bad experience at the dentist when they were a child; parent’s comfort during their last visit at the dentist). An adjusted logistic regression analysis was used to study the association between high levels of children’s dental anxiety (CFSS-DS) and parental anxiety (parent's fear of dentists; parent’s previous bad experience at the dentist when they were a child; parent’s comfort during their last visit at the dentist). For all multivariable regression analyses, independent variables included child’s age, sex, presence of any medical conditions, parents’ education level, parents smoking status, family income, patient’s weight category, presence of malocclusion, and caries percentage. For both negative binomial regression models, we reported the coefficient and 95% confidence interval (95% CI). We selected the negative binomial regression since the distribution of these dependent count variables exhibited over-dispersion. For the logistic regression analysis, we reported the adjusted odds ratio and 95% confidence interval. A P-value of 0.05 was used to evaluate the significance of all the models in the study. We used Stata/SE16.1 (StataCorp, College Station, TX, USA) to analyze the data.