NCT04678596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
1 year until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

September 30, 2019

Last Update Submit

December 16, 2020

Conditions

Tooth CrowdingTooth; Lesion, White Spot Lesions

Outcome Measures

Primary Outcomes (2)

  • Aesthetic and comfortable orthodontic treatment with aligner systems

    Surveys

    2 years

  • Comfortable orthodontic treatment with aligner systems

    Visual Analog Score for pain

    2 years

Secondary Outcomes (2)

  • Quality of life at orthodontic treatment with aligner systems

    2 years

  • Evaluation of white spot lesion formation

    2 years

Other Outcomes (2)

  • Evaluation of white spot lesion formation

    2 years

  • Change of pain during treatment

    2 years

Study Arms (2)

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.

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.

Device: Clearfix

Interventions

EonAlignerDEVICE

EonAligner system is one stage system.

EonAligner
ClearfixDEVICE

Clearfix system is three-stage system.

Clearfix

Eligibility Criteria

Age16 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Orthodontic treatment history
  • Missing tooth
  • Poor oral hygiene
  • Lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University, Faculty of Dentistry, Department of Orthodontics University university

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 26926020BACKGROUND

  • 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.

    PMID: 21208070BACKGROUND

  • 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.

    PMID: 17373221RESULT

  • 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.

    PMID: 6758594RESULT

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • meltem özsaygılı, Research Ass

    Erciyes University Faculty of Dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 30, 2019

First Posted

December 22, 2020

Study Start

December 6, 2017

Primary Completion

May 10, 2018

Study Completion

December 6, 2019

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

TU(1)