- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06436664
The Effects of Different Tooth Brushing Explanations in Fixed Orthodontic Treatment
Evaluation of the Effects of Different Tooth Brushing Explanations on Oral Hygiene in Patients With Fixed Orthodontic Treatment
Study Overview
Status
Intervention / Treatment
Detailed Description
Because orthodontic appliances cause food retention, a good level of oral hygiene is needed to maintain dental health. Inadequate tooth brushing can lead to gingival diseases on periodontal tissue, cavities and white lesions on tooth enamel. Antimicrobial agents and fluoride products are useful but it cannot replace the mechanical removal of plaque. Because the mechanical plaque control is still considered the most important oral hygiene tool during orthodontic treatment.
In the literature, it has been reported that the motivation to maintain oral hygiene during the orthodontic fixed treatment phase has a very positive effect on periodontal health, and in the same studies, plaque index scores increased over time in control groups that were not given repeated oral treatment. If patients are not given repeated and regular oral hygiene motivation in every session in the clinical routine, gum health may deteriorate. More invasive methods may be required to correct this condition. Because poor oral hygiene, if left unchecked, can compromise the outcome of orthodontic treatment.
When performing manual tooth brushing, the modified Bass technique (MBT) is often recommended to provide optimum plaque reduction by protecting oral tissues from mechanical irritation. The problem with this brushing technique is that it consists of a complex sequence of movements. First of all, the toothbrush should be positioned at a 45° angle to the gingival edge. Secondly, the brush should be moved back and forth with small horizontal vibrations. Thirdly, debris must be removed by sweeping the brush towards the occlusal face in a vertical motion (upward in the lower jaw, downwards in the upper jaw). This sequence of movements requires dexterity and attention to technique. Brushing demonstration techniques or sequences have been developed through a brochure, a model, or video.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Van, Turkey, 65080
- Yasemin TUNCA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patient with orthodontic attachments at least 4 months
- with permanent dentition
Exclusion Criteria:
- impacted or atypically erupted teeth
- with prosthetic restorations such as crowns or implants
- open bite
- deep bite
- crowding more than 7 mm or polydiastema cases
- Individuals diagnosed with periodontitis
- ndividuals with cleft lip and palate or other craniofacial anomalies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group
In patients receiving fixed orthodontic treatment, the orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months.
No special instructions will be given to these patients regarding the tooth brushing process.
|
Firstly, the toothbrush must be positioned at a 45° angle to the gingival margin.
Secondly, the brush should be moved back and forth in small horizontal jerks.
Thirdly, with a vertical movement, the brush should be moved in the occlusal direction, i.e. upwards in the lower jaw and downwards in the upper jaw to remove debris.
|
|
Experimental: Group 1
Patients will receive a standard brochure and oral presentation on tooth brushing in the Group 1.
The orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months.
These patients will receive a standardized brochure for tooth brushing.
|
Firstly, the toothbrush must be positioned at a 45° angle to the gingival margin.
Secondly, the brush should be moved back and forth in small horizontal jerks.
Thirdly, with a vertical movement, the brush should be moved in the occlusal direction, i.e. upwards in the lower jaw and downwards in the upper jaw to remove debris.
|
|
Experimental: Group 2
Patients will receive a standard tooth brushing on a dental model in the Group 2. The orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months.
|
Firstly, the toothbrush must be positioned at a 45° angle to the gingival margin.
Secondly, the brush should be moved back and forth in small horizontal jerks.
Thirdly, with a vertical movement, the brush should be moved in the occlusal direction, i.e. upwards in the lower jaw and downwards in the upper jaw to remove debris.
|
|
Experimental: Group 3
In patients undergoing fixed orthodontic treatment, the orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months.
Patients will be taught standard tooth brushing with a video in Group 3.
|
Firstly, the toothbrush must be positioned at a 45° angle to the gingival margin.
Secondly, the brush should be moved back and forth in small horizontal jerks.
Thirdly, with a vertical movement, the brush should be moved in the occlusal direction, i.e. upwards in the lower jaw and downwards in the upper jaw to remove debris.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Turesky modified index
Time Frame: Baseline, 1st month, 3rd month
|
The Turesky modified index, plaque on the buccal and lingual surfaces of all teeth. TMQHI scores were recorded as follows: 0, no dental plaque present,
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Baseline, 1st month, 3rd month
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Orthodontic plaque index
Time Frame: Baseline, 1st month, 3rd month
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Score 0: No plaque accumulation Score 1: There is plaque accumulation covering one side of the bracket base Score 2: There is plaque accumulation covering two sides of the bracket base Score 3: There is plaque accumulation covering three sides of the bracket base Score 4: There is plaque accumulation covering all four sides of the bracket base.
and/or the presence of gingival inflammation
|
Baseline, 1st month, 3rd month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival Index
Time Frame: Baseline, 1st month, 3rd month
|
Score 0: Healthy gingiva, Score 1: Gingival characterised by mild inflammation, mild discolouration, mild oedema, no bleeding on probing, Score 2: Moderate inflammation, gingiva shiny, red and oedematous.
There is bleeding on probing, Score 3: Severe inflammation, marked redness and oedema.
There is a tendency to spontaneous bleeding.
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Baseline, 1st month, 3rd month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yasemin TUNCA, PhD, Van Yüzüncü Yil University
- Study Director: Dicle ALTINDAL, DDS, Van Yüzüncü Yil University
- Study Chair: Nihal FAHRZADEH, PhD, Van Yüzüncü Yil University
- Study Chair: Murat Tunca, PhD, Van Yüzüncü Yil University
Publications and helpful links
General Publications
- Cozzani M, Ragazzini G, Delucchi A, Mutinelli S, Barreca C, Rinchuse DJ, Servetto R, Piras V. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication. Prog Orthod. 2016 Dec;17(1):41. doi: 10.1186/s40510-016-0154-9. Epub 2016 Dec 19.
- Renton-Harper P, Addy M, Newcombe RG. Video instruction to establish a panel of experts to compare tooth cleaning by 4 electric toothbrushes. J Clin Periodontol. 2001 Oct;28(10):917-22. doi: 10.1034/j.1600-051x.2001.028010917.x.
- Diamanti-Kipioti A, Gusberti FA, Lang NP. Clinical and microbiological effects of fixed orthodontic appliances. J Clin Periodontol. 1987 Jul;14(6):326-33. doi: 10.1111/j.1600-051x.1987.tb00979.x. Erratum In: J Clin Periodontol 1990 Jan;17(1):66.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/01-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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