Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal

Healthy Clinical Trial

Official title:

Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal in Children Aged 10-12 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547531
• Other study ID #: 5910820024
• Status: Completed
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: September 6, 2017

Study information

• Verified date: June 2019
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 6, 2017
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Healthy
• Mouth, Edentulous

Intervention

Other:
• Natural Tooth Brushing Method
Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.
• Modified Circular Tooth Brushing Method
Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.

Locations

Country	Name	City	State
Indonesia	Caturtunggal IV State Elementary School and Babarsari State Elementary School	Sleman	Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Plaque Level	Plaque level is examined using "Turesky Modification of Quigley-Hein Index". The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces).	Baseline
Primary	Baseline Gingival Condition	The examination of gingival condition was using the Gingival Index by Silness and Loe. A score between 0 and 3 was given based on the criteria: 0= Normal gingiva.; Mild inflammation - slight change in color, slight edema. No bleeding on probing.; Moderate inflammation - redness, edema and glazing. Bleeding on probing.; Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding.; This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal).	Baseline
Primary	Plaque Level at 1 Month	Plaque level is examined using "Turesky Modification of Quigley-Hein Index". The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces).	one month after baseline data collection
Primary	Gingival Condition at 1 Month	The examination of gingival condition was using the Gingival Index by Silness and Loe. A score between 0 and 3 was given based on the criteria: 0= Normal gingiva.; Mild inflammation - slight change in color, slight edema. No bleeding on probing.; Moderate inflammation - redness, edema and glazing. Bleeding on probing.; Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding.; This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal).	one month after baseline data collection