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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Natural Tooth Brushing Method
Modified Circular Tooth Brushing Method
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

10 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Caturtunggal IV State Elementary School and Babarsari State Elementary School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Natural Tooth Brushing Method

Modified Circular Tooth Brushing Method

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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 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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
May 11, 2018
Last Updated
June 19, 2019
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT03547531
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
September 6, 2017 (Actual)
Study Completion Date
September 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Plaque level in subjects using the Modified Circular method is different from that in subjects using natural tooth brushing method. Gingivitis level in subjects using the Modified Circular method is different from that in subjects using natural tooth brushing method. Level of plaque after using the Modified Circular method is different from that before using the method. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the data were gathered from two groups of participants (control and intervention groups)
Masking
Outcomes Assessor
Masking Description
Examiner was blind to the allocation of the group
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natural Tooth Brushing Method
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Modified Circular Tooth Brushing Method
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Natural Tooth Brushing Method
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Modified Circular Tooth Brushing Method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Plaque Level
Description
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
Title
Baseline Gingival Condition
Description
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).
Time Frame
Baseline
Title
Plaque Level at 1 Month
Description
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
Title
Gingival Condition at 1 Month
Description
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).
Time Frame
one month after baseline data collection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Istiyanti Hapsari
Organizational Affiliation
Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caturtunggal IV State Elementary School and Babarsari State Elementary School
City
Sleman
State/Province
Yogyakarta
ZIP/Postal Code
55281
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data must be kept confidential to protect the privacy of participants. The shared data will be in the results in publication.

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

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