Clinical trial NCT03547531: Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal
Official title: Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal in Children Aged 10-12 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 124
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the data were gathered from two groups of participants (control and intervention groups)
Primary purpose: TREATMENT

Brief summary: 1. Plaque level in subjects using the Modified Circular method is different from that in subjects using natural tooth brushing method.
2. Gingivitis level in subjects using the Modified Circular method is different from that in subjects using natural tooth brushing method.
3. Level of plaque after using the Modified Circular method is different from that before using the method.
4. Level of gingivitis after using the Modified Circular method is different from that before using the method.

Detailed description: Dental caries and gingivitis prevalences in schoolchildren in Indonesia is high. Dental diseases can potentially caused missed school, concentration disturbance, impaired speech, poor self-esteem, and systemic illness. Caries and gingivitis can be prevented by maintaining oral hygiene. Toothbrushing is one of oral hygiene method to remove and prevent dental plaque that can cause dental caries and gingivitis. The aim of the study was to compare the level of plaque and gingivitis of children aged 10-12 years old that use the Modified Circular and natural tooth brushing methods.

One hundred and twenty four students from two state elementary school in Yogyakarta, Indonesia participated in this study. The age of the participants were between 10 and 12 years old including males and females students. All of the participants were fifth graders from two elementary schools. To be eligible to participate in this study, each participants met the criteria including: students with age 10 to 12 years old and willing as well as permitted by the parents/guardian to join thorough the study. The exclusion criteria were being diagnosed having developmental disorder, using orthodontic appliances, and using antiseptic mouthwash for daily use.

The study began with the baseline data collection. Then it continued with the training for the participants about improving the oral hygiene. Children will be instructed to brush their teeth two times a day in the morning and before bedtime with the duration of 2 minutes. The project provided one toothpaste and one toothbrush for each children. In this stage, the intervention group was demonstrated and instructed to brush their teeth using Modified Circular method, while the control group was not given any instruction to brush their teeth using a specific tooth brushing method and asked to brush their teeth using the way they brushing every day. The period of intervention was started after training and lasted for one month. In intervention period, intervention group was observed once a week to ensure that they brushed their teeth correctly using Modified Circular method. Finally the evaluation was implemented after 1 month of intervention. The duration of the trial was one month, started in 2 August 2017 and finished on 6 September 2017, and the study was finished in time.

This study did not use any invasive treatment due to oral examination. No drugs or chemical materials were used except nontoxic disclosing agent that was used only 2-3 drops for staining the dental plaque. The colors of disclosing agent will gradually disapear and easily removed by brushing.

The benefit of this study was to help teachers, parents, and students to know the level of oral cleanliness and the effective method of toothbrushing in order to maintain oral hygiene and prevent dental caries and gingivitis.

The participants recruitment started after the research permission from government were accepted on 29 July 2017 until 31 July 2017. The schools selected then received the research permit from government and the research was started by giving the informed consent to the children and parents. The funding of this study is from Graduate School Prince of Songkla University Research Funding and Faculty of Dentistry Prince of Songkla University Research Funding.

The principle investigator of this study (as the main contact) is Istiyanti Hapsari (e-mail istiyantihapsari@gmail.com).

Eligibility criteria: Inclusion Criteria:

* Students with age 10 to 12 years old and willing as well as permitted by the parents/guardian to join thorough the study.

Exclusion Criteria:

* Being diagnosed having developmental disorder, using orthodontic appliances, and using antiseptic mouthwash for daily use.

Primary outcomes:
measure: Baseline Plaque Level
timeFrame: Baseline
measure: Baseline Gingival Condition
timeFrame: Baseline
measure: Plaque Level at 1 Month
timeFrame: one month after baseline data collection
measure: Gingival Condition at 1 Month
timeFrame: one month after baseline data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: Caturtunggal IV State Elementary School and Babarsari State Elementary School
state: Yogyakarta
Study officials:
affiliation: Prince of Songkla University
name: Istiyanti Hapsari
role: PRINCIPAL_INVESTIGATOR
References: