Tooth CrowdingNCT04678596
Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage
A study testing EonAligner and Clearfix in people with Tooth Crowding and Tooth; Lesion, White Spot Lesions, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Applying to the Orthodontics Department of the Faculty of Dentistry of Erciyes University for orthodontic treatment, a periodontally healthy 16-26 year-old periodontally healthy, non-congenital or congenital anomaly in the craniofacial region; 25 patients with class 1 orthodontic malocclusion with moderate… Read more about this study
- Who is it for?
- Ages 16 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Crowding, Tooth; Lesion, White Spot Lesions
- What is being tested?
- EonAligner and Clearfix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2017to 6 Dec 2019
- 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 16 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- No systemic disease
- Being healthy as periodontal.
- No smoking.
- No previous orthodontic treatment.
- Lack of congenital tooth deficiency
- Permanent dentition
Show all 9Show fewer
- Class 1 malocclusion
- No clefts
- No extracted teeth
Who cannot join
- Orthodontic treatment history
- Missing tooth
- Poor oral hygiene
- Lack of cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University, Faculty of Dentistry, Department of Orthodontics University university
Kayseri, Melikgazi, 38039
About this study
Official title: Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage In Terms Of Comfort, Satisfaction, Treatment Effects And Duration
Applying to the Orthodontics Department of the Faculty of Dentistry of Erciyes University for orthodontic treatment, a periodontally healthy 16-26 year-old periodontally healthy, non-congenital or congenital anomaly in the craniofacial region; 25 patients with class 1 orthodontic malocclusion with moderate permeability will be included in the study. The patients will be divided into 2 groups, and the first group of 12 patients will have single-stage aligner; The second group of 13 patients is planned to apply 3-stage aligner.
Read the detailed description
It is planned to take lateral cephalometric radiography, panoramic radiography before and after the orthodontic treatment, and in addition to orthodontic model and photograph records before, during and after the treatment. Patient comfort and satisfaction will be evaluated by applying questionnaires to patients before treatment, immediately after starting treatment, 2 days later, 1 week later, 1 month later, 1 week before and after the treatment, and the effects of 2 different treatment methods on the patients will be evaluated according to the data obtained. QLF recordings are also taken at the beginning of treatment and at 3-month intervals, and the effects of single plaque use and 3 different plaque use on white spot lesion formation will be evaluated.
Hays Nance analysis will be used in the orthodontic models to determine the change in the amount of perplexity. In this way, tooth movement speeds can be determined. There are studies in the literature with single-stage transparent plates, but there are no studies with different-stage plates. In our study, which of the two different types of treatment is more comfortable on patients and affects the movement of teeth faster; In addition, the investigators plan to investigate which one has a low risk of white spot lesions on the teeth.
- Conditions
- Tooth Crowding, Tooth; Lesion, White Spot Lesions
- Being tested
- EonAligner, Clearfix
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EonAlignerDevice
EonAligner system is one stage system.
ClearfixDevice
Clearfix system is three-stage system.
| Study group | Role | What they receive |
|---|---|---|
| EonAligner | Active comparator | Patients in the EonAligner group were given a single thickness and hardness aligner and were asked to use the same it for 3 weeks. Receives: Device: EonAligner |
| Clearfix | Active comparator | In the Clearfix group, the patients were given three different thickness and hardness aligner and they were asked to use each aligner for one week from soft to hard. Receives: Device: Clearfix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic and comfortable orthodontic treatment with aligner systems
Surveys
Measured: 2 years
Comfortable orthodontic treatment with aligner systems
Visual Analog Score for pain
Measured: 2 years
Secondary outcomes (2)
Quality of life at orthodontic treatment with aligner systems
Physicians Global Assessment to measure quality of life
Measured: 2 years
Evaluation of white spot lesion formation
rate of new white spot formation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start6 Dec 2017
- Primary completion10 May 2018
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tooth CrowdingStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Yağcı, TC Erciyes University
- Investigators
- meltem özsaygılı, Research Ass, Study chair, Erciyes University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678596
- Sponsor's protocol ID
- TDH-2017-7774
- Status last verified
- Dec 2020
- First submitted
- 30 Sep 2019
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yagci A, Korkmaz YN, Buyuk SK, Yagci F, Atilla AO. White spot lesion formation after treatment with full-coverage rapid maxillary expanders. Am J Orthod Dentofacial Orthop. 2016 Mar;149(3):331-8. doi: 10.1016/j.ajodo.2015.08.015.
PubMed 26926020Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.
PubMed 21208070Kim TW, Echarri P. Clear aligner: an efficient, esthetic, and comfortable option for an adult patient. World J Orthod. 2007 Spring;8(1):13-8.
PubMed 17373221Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.
PubMed 6758594
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage In Terms Of Comfort, Satisfaction, Treatment Effects And Duration
- ClinicalTrials.gov ID
- NCT04678596
- Acronym / sponsor ID
- TDH-2017-7774
- Conditions
- Tooth Crowding, Tooth; Lesion, White Spot Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 22 Dec 2020 (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.
Applying to the Orthodontics Department of the Faculty of Dentistry of Erciyes University for orthodontic treatment, a periodontally healthy 16-26 year-old periodontally healthy, non-congenital or congenital anomaly in the craniofacial region; 25 patients with class 1 orthodontic malocclusion with moderate permeability will be included in the study. The patients will be divided into 2 groups, and the first group of 12 patients will have single-stage aligner; The second group of 13 patients is planned to apply 3-stage aligner.
Detailed description
It is planned to take lateral cephalometric radiography, panoramic radiography before and after the orthodontic treatment, and in addition to orthodontic model and photograph records before, during and after the treatment. Patient comfort and satisfaction will be evaluated by applying questionnaires to patients before treatment, immediately after starting treatment, 2 days later, 1 week later, 1 month later, 1 week before and after the treatment, and the effects of 2 different treatment methods on the patients will be evaluated according to the data obtained. QLF recordings are also taken at the beginning of treatment and at 3-month intervals, and the effects of single plaque use and 3 different plaque use on white spot lesion formation will be evaluated.
Hays Nance analysis will be used in the orthodontic models to determine the change in the amount of perplexity. In this way, tooth movement speeds can be determined. There are studies in the literature with single-stage transparent plates, but there are no studies with different-stage plates. In our study, which of the two different types of treatment is more comfortable on patients and affects the movement of teeth faster; In addition, the investigators plan to investigate which one has a low risk of white spot lesions on the teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EonAligner | Active comparator | Device: EonAlignerPatients in the EonAligner group were given a single thickness and hardness aligner and were asked to use the same it for 3 weeks. |
| Clearfix | Active comparator | Device: ClearfixIn the Clearfix group, the patients were given three different thickness and hardness aligner and they were asked to use each aligner for one week from soft to hard. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- No systemic disease
- Being healthy as periodontal.
- No smoking.
- No previous orthodontic treatment.
- Lack of congenital tooth deficiency
Key exclusion criteria (4 listed)
- Orthodontic treatment history
- Missing tooth
- Poor oral hygiene
- Lack of cooperation
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 |
|---|---|---|
| EonAlignerEonAligner system is one stage system. | Device | EonAligner |
| ClearfixClearfix system is three-stage system. | Device | Clearfix |
Primary outcome
Aesthetic and comfortable orthodontic treatment with aligner systems
Time frame: 2 years
Surveys
Comfortable orthodontic treatment with aligner systems
Time frame: 2 years
Visual Analog Score for pain
2 secondary outcomes
Quality of life at orthodontic treatment with aligner systems
Time frame: 2 years
Evaluation of white spot lesion formation
Time frame: 2 years
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 22 Dec 2020.
- Background: PubMed 26926020Yagci A, Korkmaz YN, Buyuk SK, Yagci F, Atilla AO. White spot lesion formation after treatment with full-coverage rapid maxillary expanders. Am J Orthod Dentofacial Orthop. 2016 Mar;149(3):331-8. doi: 10.1016/j.ajodo.2015.08.015.
- Background: PubMed 21208070Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.
- Results publication: PubMed 17373221Kim TW, Echarri P. Clear aligner: an efficient, esthetic, and comfortable option for an adult patient. World J Orthod. 2007 Spring;8(1):13-8.
- Results publication: PubMed 6758594Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.
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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.
meltem özsaygılı, Research Ass study chair
Erciyes University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EonAligner and Clearfix in people with Tooth Crowding and Tooth; Lesion, White Spot Lesions, run by TC Erciyes 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 9 inclusion and 4 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 22 Dec 2020. 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?
Aesthetic and comfortable orthodontic treatment with aligner systems (time frame: 2 years). 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 NCT04678596, which also lists 4 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 22 Dec 2020; AzTrials last refreshed its copy on 1 Nov 2026.