Healthy
Conditions
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).
Interventions
OTHERNatural 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.
OTHERModified 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.
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Examiner was blind to the allocation of the group
Intervention model description
the data were gathered from two groups of participants (control and intervention groups)
Eligibility
Sex/Gender
ALL
Age
10 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Plaque Level | Baseline | 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 Gingival Condition | Baseline | 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. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding. This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal). |
| Plaque Level at 1 Month | one month after baseline data collection | 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). |
| Gingival Condition at 1 Month | one month after baseline data collection | 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. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding. This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal). |
Countries
Indonesia
Participant flow
Recruitment details
All of the participants were fifth graders from 2 elementary schools in Yogyakarta, Indonesia. These two schools have the similar characteristics in social-economy, number of students, and the type of school based on the data and recommendation from Education and Culture Office of Sleman District, Yogyakarta, Indonesia.
Pre-assignment details
Each school had 62 fifth graders (total participants of both school was 124 fifth graders). No participants were excluded. Random group assignment was done by coin flipping to choose one school as control group and the other as intervention group.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 62 |
| 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.
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. | 1,326 |
| 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.
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. | 62 |
| 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.
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. | 1,328 |
| Total | 2,778 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | having family occasion | 0 | 2 |
| Overall Study | not coming in data collection : sick | 2 | 2 |
Baseline characteristics
| Characteristic | Modified Circular Tooth Brushing Method | Total | Natural Tooth Brushing Method |
|---|---|---|---|
| Age, Customized Age of participants | 10.8 years STANDARD_DEVIATION 0.342 | 10.8 years STANDARD_DEVIATION 0.365 | 10.9 years STANDARD_DEVIATION 0.379 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Indonesia | 62 Participants | 124 Participants | 62 Participants |
| Sex: Female, Male Female | 34 Participants | 70 Participants | 36 Participants |
| Sex: Female, Male Male | 28 Participants | 54 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 62 |
| other Total, other adverse events | 0 / 62 | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 | 0 / 62 |
Outcome results
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. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding. This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Natural Tooth Brushing Method | Baseline Gingival Condition | 0.51 gingival index | Standard Deviation 0.28 |
| Modified Circular Tooth Brushing Method | Baseline Gingival Condition | 0.49 gingival index | Standard Deviation 0.4 |
Comparison: null hypotesis: there is no difference of mean of gingival index between groupsp-value: >0.05t-test, 2 sided
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Natural Tooth Brushing Method | Baseline Plaque Level | 2.25 plaque index | Standard Deviation 0.65 |
| Modified Circular Tooth Brushing Method | Baseline Plaque Level | 2.28 plaque index | Standard Deviation 1.68 |
Comparison: Null hypothesis: the mean of plaque index between groups are not differentp-value: >0.05t-test, 2 sided
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. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding. This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal).
Time frame: one month after baseline data collection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Natural Tooth Brushing Method | Gingival Condition at 1 Month | 0.49 gingival index | Standard Deviation 0.4 |
| Modified Circular Tooth Brushing Method | Gingival Condition at 1 Month | 0.28 gingival index | Standard Deviation 0.33 |
Comparison: null hypotesis: there is no difference of mean of gingival index between groupsp-value: <0.05t-test, 2 sided
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).
Time frame: one month after baseline data collection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Natural Tooth Brushing Method | Plaque Level at 1 Month | 2.28 plaque index | Standard Deviation 1.19 |
| Modified Circular Tooth Brushing Method | Plaque Level at 1 Month | 1.68 plaque index | Standard Deviation 1.08 |
Comparison: null hypotesis: there is no difference of mean of plaque index between groupsp-value: <0.05t-test, 2 sided