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

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ClinicalTrials.gov Identifier: NCT03547531
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Istiyanti Hapsari, Prince of Songkla University

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Natural Tooth Brushing Method Other: Modified Circular Tooth Brushing Method Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: the data were gathered from two groups of participants (control and intervention groups)
Masking: Single (Outcomes Assessor)
Masking Description: Examiner was blind to the allocation of the group
Primary Purpose: Treatment
Official Title: Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal in Children Aged 10-12 Years Old
Actual Study Start Date : August 2, 2017
Actual Primary Completion Date : September 6, 2017
Actual Study Completion Date : September 6, 2017

Arm Intervention/treatment
Active Comparator: 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.
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.

Experimental: 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.
Other: 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.




Primary Outcome Measures :
  1. Baseline plaque level [ Time Frame: Baseline ]
    examined using Turesky Modification of Quigley-Hein Index

  2. Baseline gingival condition [ Time Frame: Baseline ]
    examined using Gingival Index

  3. Plaque level at 1 month [ Time Frame: one month after baseline data collection ]
    examined using Turesky Modification of Quigley-Hein Index

  4. Gingival condition at 1 month [ Time Frame: one month after baseline data collection ]
    examined using Gingival Index



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547531


Locations
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Indonesia
Caturtunggal IV State Elementary School and Babarsari State Elementary School
Sleman, Yogyakarta, Indonesia, 55281
Sponsors and Collaborators
Prince of Songkla University
Investigators
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Principal Investigator: Istiyanti Hapsari Prince of Songkla University

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Responsible Party: Istiyanti Hapsari, Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal in Children Aged 10-12 Years Old, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT03547531     History of Changes
Other Study ID Numbers: 5910820024
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dental Plaque
Mouth, Edentulous
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Mouth Diseases