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Effects of orthodontic treatment with clear aligner and conventional fixed appliance

Effects of orthodontic treatment with clear aligner and fixed appliance: randomized clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-9zytwf
Enrollment
Unknown
Registered
2019-10-25
Start date
2019-06-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malocclusion

Interventions

Experimental group: 20 participants, both sexes, who will receive complete corrective orthodontic treatment through aesthetic aligners (CAT) Control Group: 20 participants, both sexes, who will receiv
Procedure/surgery

Sponsors

Align Technology, Inc
Lead Sponsor
Unopar
Collaborator
3M do Brasil
Collaborator

Eligibility

Age
13 Years to 35 Years

Inclusion criteria

Inclusion criteria: Fifteen to 35 years of age; both sexes; Angle Class I malocclusion; moderate anteroinferior crowding and treatment without extraction.

Exclusion criteria

Exclusion criteria: Absence of permanent teeth, anterior or posterior open bite, anterior or posterior crossbite, previous orthodontic treatment.

Design outcomes

Primary

MeasureTime frame
-External apical root resorption (EARR): Periapical radiographs of upper and lower incisors, performed before, after 6 months and at the end of orthodontic treatment, will be used. To verify the degree and magnitude of the EARR, the periapical radiographs will be scanned with a 1:1 x-ray scanner (HP 4050) at 600 dpi resolution. These images will be analyzed by means of using the CorelDRAW X7 software, with a resolution of 0.01 mm. The tooth length will be measured by means of the radicular apex distance - incisal edge of the referred teeth. The differences in the length of the measured teeth throughout the study (baseline, 6 months and end of treatment) will be calculated to assess the degree and magnitude of reabsorption.

Secondary

MeasureTime frame
- Degree of hyper vigilance: a hypervigilance questionnaire will also be applied to participants, composed of 16 items with six response options (0 = "never" to 5 = "always"). This questionnaire is based on the behavior of individuals according to the painful experiences already experienced. The sum of the scores will be correlated with the behavior of awake bruxism registered, since this variable can instigate a higher frequency of this parafunctional habit.;- Catastrophic Pain Questionnaire: the Scale of Catastrophic Thoughts on Pain is composed of 9 items on a Likert scale ranging from 0 to 5 points associated with words almost never and almost always at the extremities. The minimum score can be 0 and maximum 5 and this result will be correlated with pain perception, since this variable can instigate greater pain symptomatology, masking the results of comparison between orthodontic protocols. ;- Recording occlusal contact points: the occlusal contacts will also be recorded for the two groups of the research by means of an eight micron carbon paper strip (AccuFilm - USA). This record will be made in maximum habitual intercuspation and all identified contacts will be copied to an occlusogram that is part of the clinical record. It is hoped to evaluate whether treatment protocols could influence the number and location of occlusal contacts. Likely similar changes in occlusal patterns will be observed in both groups, since during the beginning of the treatment the teeth are moved in greater magnitude to correct the crowding. ;- Pressure Pain Threshold Test (PPT): the pressure pain threshold will be measured by palpation with the help of a high precision algometer made in Brazil by KRATOS®. The muscles chosen to perform the test will be the anterior temporal and masseter body region on both sides. The exam will be performed randomly between the chosen muscles and repeated three times at each location. PPT measurements will be performed prior to the installation of t

Countries

Brazil

Contacts

Public ContactPaula Oltramari

Unopar

pvoltramari@hotmail.com+55-43-33717991

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 24, 2026