Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage
Primary Purpose
Tooth Crowding, Tooth; Lesion, White Spot Lesions
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EonAligner
Clearfix
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Crowding
Eligibility Criteria
Inclusion Criteria:
- No systemic disease
- Being healthy as periodontal.
- No smoking.
- No previous orthodontic treatment.
- Lack of congenital tooth deficiency
- Permanent dentition
- Class 1 malocclusion
- No clefts
- No extracted teeth
Exclusion Criteria:
- Orthodontic treatment history
- Missing tooth
- Poor oral hygiene
- Lack of cooperation
Sites / Locations
- Erciyes University, Faculty of Dentistry, Department of Orthodontics University university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EonAligner
Clearfix
Arm Description
Patients in the EonAligner group were given a single thickness and hardness aligner and were asked to use the same it for 3 weeks.
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.
Outcomes
Primary Outcome Measures
Aesthetic and comfortable orthodontic treatment with aligner systems
Surveys
Comfortable orthodontic treatment with aligner systems
Visual Analog Score for pain
Secondary Outcome Measures
Quality of life at orthodontic treatment with aligner systems
Physicians Global Assessment to measure quality of life
Evaluation of white spot lesion formation
rate of new white spot formation
Full Information
NCT ID
NCT04678596
First Posted
September 30, 2019
Last Updated
December 16, 2020
Sponsor
TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT04678596
Brief Title
Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage
Official Title
Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage In Terms Of Comfort, Satisfaction, Treatment Effects And Duration
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
December 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Crowding, Tooth; Lesion, White Spot Lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EonAligner
Arm Type
Active Comparator
Arm Description
Patients in the EonAligner group were given a single thickness and hardness aligner and were asked to use the same it for 3 weeks.
Arm Title
Clearfix
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EonAligner
Intervention Description
EonAligner system is one stage system.
Intervention Type
Device
Intervention Name(s)
Clearfix
Intervention Description
Clearfix system is three-stage system.
Primary Outcome Measure Information:
Title
Aesthetic and comfortable orthodontic treatment with aligner systems
Description
Surveys
Time Frame
2 years
Title
Comfortable orthodontic treatment with aligner systems
Description
Visual Analog Score for pain
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of life at orthodontic treatment with aligner systems
Description
Physicians Global Assessment to measure quality of life
Time Frame
2 years
Title
Evaluation of white spot lesion formation
Description
rate of new white spot formation
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Evaluation of white spot lesion formation
Description
rate of new white spot formation
Time Frame
2 years
Title
Change of pain during treatment
Description
measurement of pain level (grading system, VAS scoring)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No systemic disease
Being healthy as periodontal.
No smoking.
No previous orthodontic treatment.
Lack of congenital tooth deficiency
Permanent dentition
Class 1 malocclusion
No clefts
No extracted teeth
Exclusion Criteria:
Orthodontic treatment history
Missing tooth
Poor oral hygiene
Lack of cooperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
meltem özsaygılı, Research Ass
Organizational Affiliation
Erciyes University Faculty of Dentistry
Official's Role
Study Chair
Facility Information:
Facility Name
Erciyes University, Faculty of Dentistry, Department of Orthodontics University university
City
Kayseri
State/Province
Melikgazi
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
26926020
Citation
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.
Results Reference
background
PubMed Identifier
21208070
Citation
Tufekci 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 Reference
background
PubMed Identifier
17373221
Citation
Kim 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 Reference
result
PubMed Identifier
6758594
Citation
Gorelick 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.
Results Reference
result
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Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage
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