See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Damien Brezulier
Université de Rennes 1
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1519-9943
License:
This work is licensed under a CC BY 4.0 License. Read Full License
1.1 Background
Fixed orthodontics appliances hamper oral hygiene procedures. The consequences are gingivitis and white spot lesions. 50 to 70% of patients treated with braces encounter these problems. Their care in the USA represents an annual cost of five hundred million dollars. Initial education and motivation for oral hygiene depend on two categories of factors. First, practical prophylactic measures (instruments and medication, professional care). Secondly, the educational component: choice of communication technique, frequency and nature of hygiene instructions. This trial aims to study this last component. Its main objective is to compare three method's effectiveness of oral hygiene education in adolescent patients treated with braces in terms of biofilm (plaque) control. The secondary objectives are the evaluation of these methods’ effectiveness regarding gingival inflammation and the maintenance of hygiene during the first six months of treatment.
1.2 Methods
This study is a prospective randomized controlled trial of superiority. It evaluates the effectiveness of three hygiene education techniques. A total of 90 patients from the University Hospital Center of Rennes will be randomized into 3 parallel groups with a 1:1:1 ratio. Each will benefit from a different educational method: oral and / or practical. The main outcome will be the average plaque index for each group after 6 months of treatment. Additional outcomes will be the average gingival index for each group and the plaque and gingival indeces over 6 months.
1.3 Discussion
The effectiveness of preventive procedures for optimizing oral hygiene during orthodontics is based on ambiguous literature. As a result, it is difficult to draw conclusions and to translate them into everyday practice. 68% of the orthodontists support the development of guidelines for education. The aim of this study is to standardize methods of oral hygiene education during orthodontic fixed treatment. The purpose of this study would be to provide practitioners with a concrete education program through guidelines dedicated to the method having the best results.
1.4 Trial registration
This trial is registered with the ClinicalTrial.gov under number NCT04444154, registration date 06/22/2020. It is also regristered in SI CNRIPH with ID 8011N° 20.04.27.58337.
Keywords
Orthodontic treatment, oral health, education, auditory learning, visual learning, kinesthetic learning, study protocol, guideline, prevention.
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CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 13 Jan, 2021
No community comments so far
Review #2 received
Received 16 Jan, 2021
Editorial decision: Minor revision
On 16 Jan, 2021
Review #1 received
Received 11 Jan, 2021
Reviewer #3 agreed
On 07 Jan, 2021
Reviewer #2 agreed
On 06 Jan, 2021
Reviewers invited
Invitations sent on 06 Jan, 2021
Reviewer #1 agreed
On 06 Jan, 2021
Editor assigned
On 05 Jan, 2021
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On 05 Jan, 2021
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Learn more about our company.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Damien Brezulier
Université de Rennes 1
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1519-9943
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 13 Jan, 2021
No community comments so far
Review #2 received
Received 16 Jan, 2021
Editorial decision: Minor revision
On 16 Jan, 2021
Review #1 received
Received 11 Jan, 2021
Reviewer #3 agreed
On 07 Jan, 2021
Reviewer #2 agreed
On 06 Jan, 2021
Reviewers invited
Invitations sent on 06 Jan, 2021
Reviewer #1 agreed
On 06 Jan, 2021
Editor assigned
On 05 Jan, 2021
Submission checks complete
On 05 Jan, 2021
First submitted
On 05 Nov, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
1.1 Background
Fixed orthodontics appliances hamper oral hygiene procedures. The consequences are gingivitis and white spot lesions. 50 to 70% of patients treated with braces encounter these problems. Their care in the USA represents an annual cost of five hundred million dollars. Initial education and motivation for oral hygiene depend on two categories of factors. First, practical prophylactic measures (instruments and medication, professional care). Secondly, the educational component: choice of communication technique, frequency and nature of hygiene instructions. This trial aims to study this last component. Its main objective is to compare three method's effectiveness of oral hygiene education in adolescent patients treated with braces in terms of biofilm (plaque) control. The secondary objectives are the evaluation of these methods’ effectiveness regarding gingival inflammation and the maintenance of hygiene during the first six months of treatment.
1.2 Methods
This study is a prospective randomized controlled trial of superiority. It evaluates the effectiveness of three hygiene education techniques. A total of 90 patients from the University Hospital Center of Rennes will be randomized into 3 parallel groups with a 1:1:1 ratio. Each will benefit from a different educational method: oral and / or practical. The main outcome will be the average plaque index for each group after 6 months of treatment. Additional outcomes will be the average gingival index for each group and the plaque and gingival indeces over 6 months.
1.3 Discussion
The effectiveness of preventive procedures for optimizing oral hygiene during orthodontics is based on ambiguous literature. As a result, it is difficult to draw conclusions and to translate them into everyday practice. 68% of the orthodontists support the development of guidelines for education. The aim of this study is to standardize methods of oral hygiene education during orthodontic fixed treatment. The purpose of this study would be to provide practitioners with a concrete education program through guidelines dedicated to the method having the best results.
1.4 Trial registration
This trial is registered with the ClinicalTrial.gov under number NCT04444154, registration date 06/22/2020. It is also regristered in SI CNRIPH with ID 8011N° 20.04.27.58337.
Figure 1
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