Orthodontic TreatmentNCT06436664
The Effects of Different Tooth Brushing Explanations in Fixed Orthodontic Treatment
A study testing Tooth brushing in people with Orthodontic Treatment and Dental Plaque Induced Gingival Disease, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of tooth brushing training methods on orthodontic patients and to determine the most effective oral hygiene methods for individuals receiving orthodontic treatment. Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Treatment, Dental Plaque Induced Gingival Disease
- What is being tested?
- Tooth brushing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The patient with orthodontic attachments at least 4 months
- with permanent dentition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Different Tooth Brushing Explanations on Oral Hygiene in Patients With Fixed Orthodontic Treatment
The aim of this study is to investigate the effects of tooth brushing training methods on orthodontic patients and to determine the most effective oral hygiene methods for individuals receiving orthodontic treatment.
Read the 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.
- Being tested
- Tooth brushing
- Keywords
- tooth brushing, fixed orthodontic treatment, microbial dental plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth brushingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | 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. Receives: Other: Tooth brushing |
| Group 1 | Experimental | 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. Receives: Other: Tooth brushing |
| Group 2 | Experimental | 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. Receives: Other: Tooth brushing |
| Group 3 | Experimental | 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. Receives: Other: Tooth brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Turesky modified index
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,
- isolated areas of dental plaque,
- A thin dental plaque tape of ≤1 mm,
- dental plaque covered up to 1/3 of the tooth surface,
- dental plaque covered between 1/3 and 2/3 of the tooth surface,
- dental plaque covers ≥2/3 of the tooth surface.
Measured: Baseline, 1st month, 3rd month
Orthodontic plaque index
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
Measured: Baseline, 1st month, 3rd month
Secondary outcomes (1)
Gingival Index
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.
Measured: Baseline, 1st month, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Jan 2024
- Primary completion4 Mar 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthodontic TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Tunca, Yuzuncu Yil University
- Investigators
- Yasemin TUNCA, PhD, Principal investigator, Yuzuncu Yil UniversityDicle ALTINDAL, DDS, Study director, Yuzuncu Yil UniversityNihal FAHRZADEH, PhD, Study chair, Yuzuncu Yil UniversityMurat Tunca, PhD, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436664
- Sponsor's protocol ID
- 2024/01-04
- Status last verified
- Jul 2024
- First submitted
- 24 May 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27891568Renton-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.
PubMed 11686809Diamanti-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.
PubMed 3509967
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Tooth Brushing Explanations on Oral Hygiene in Patients With Fixed Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT06436664
- Acronym / sponsor ID
- 2024/01-04
- Keywords
- tooth brushing, fixed orthodontic treatment, microbial dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effects of tooth brushing training methods on orthodontic patients and to determine the most effective oral hygiene methods for individuals receiving orthodontic 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Tooth brushingIn 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. |
| Group 1 | Experimental | Other: Tooth brushingPatients 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. |
| Group 2 | Experimental | Other: Tooth brushingPatients 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. |
| Group 3 | Experimental | Other: Tooth brushingIn 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. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The patient with orthodontic attachments at least 4 months
- with permanent dentition
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth brushingFirstly, 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. | Other | Control group, Group 1, Group 2, Group 3 |
Primary outcome
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, 1. isolated areas of dental plaque, 2. A thin dental plaque tape of ≤1 mm, 3. dental plaque covered up to 1/3 of the tooth surface, 4. dental plaque covered between 1/3 and 2/3 of the tooth surface, 5. dental plaque covers ≥2/3 of the tooth surface.
Orthodontic plaque index
Time frame: Baseline, 1st month, 3rd month
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
1 secondary outcome
Gingival Index
Time frame: Baseline, 1st month, 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Results publication: PubMed 27891568Cozzani 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.
- Results publication: PubMed 11686809Renton-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.
- Results publication: PubMed 3509967Diamanti-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin TUNCA, PhD principal investigator
Yuzuncu Yil University
Dicle ALTINDAL, DDS study director
Yuzuncu Yil University
Nihal FAHRZADEH, PhD study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth brushing in people with Orthodontic Treatment and Dental Plaque Induced Gingival Disease, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Turesky modified index (time frame: Baseline, 1st month, 3rd month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06436664, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.