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Effect of Clear Aligner Wear Protocol on External Root Resorption

Effect of Clear Aligner Wear Protocol on External Root Resorption: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07522216
Enrollment
52
Registered
2026-04-13
Start date
2025-02-02
Completion date
2026-05-15
Last updated
2026-04-13

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

Conditions

Clear Aligner Therapy

Keywords

Root resorption, Aligner wearing protocol

Brief summary

The aim of this two-arm randomized clinical trial was to compare the effect of 7-day and 14-day orthodontic clear aligner wear protocols on external apical root resorption (EARR) and pain perception

Detailed description

Fifty adult patients (21 Male and 29 female with a mean age of 23.7 ± 1.8) presented at the postgraduate orthodontic clinics at Jordan University of Science and Technology (JUST) were randomly allocated into a 7-day or 14-day aligner change protocol. Each patient underwent a standardized series of digital periapical radiographs (three upper and three lower). Baseline radiographs (T0) were taken before the initiation of treatment, and follow-up radiographs (T1) were collected after six months of aligner therapy. EARR was measured from a line drawn at the cemento-enamel junction (CEJ) to the tooth's apex before treatment (T₀), and after treatment (T1), the difference in length was calculated and graded using the Malmgren Index. Pain perception was assessed using a verbal rating scale (VRS) at six-time intervals (24 hours, first week, second week, first month, third month and sixth month). Statistical analyses were used to compare pre- and post-treatment changes within and between the groups. Multiple linear regression was used to identify predictors of EARR.

Interventions

OTHERDiffernt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols

One group should change the orthodontic clear aligner every week (7 days) and the second group every two weeks (14 days)

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Participants with complete permanent dentition except wisdom teeth * Participants presented with mild to moderate malocclusion (Average degree of crowding). * Participants with good oral hygiene and absence of periodontal disease. * No history of trauma or prior orthodontic treatment.

Exclusion criteria

* Participants with thin or petite roots. * Participants with pre-existing root resorption * Participants with endodontically treated incisors or canines. * Participants with history of trauma to incisors teeth * Participants with previous orthodontic treatment. * Participants with periapical pathology, ankylosisor cystic lesions. * Participants with medical conditions that may affecting pain or inflammatory responses.

Design outcomes

Primary

MeasureTime frameDescription
Root resorption6 monthsPeri-apical radiographs will be taken before and after the treatment, tooth root length will be measured before and after treatment from the radiographs

Secondary

MeasureTime frameDescription
Pain perceptionAfter 24 hours, 1 week, 2 weeks, 1 month, 3 months and 6 monthsPain perception will be measured in the two groups

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026