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Effect of Clear Aligner Wear Protocol on External Root Resorption

J

Jordan University of Science and Technology

Status

Active, not recruiting

Conditions

Clear Aligner Therapy

Treatments

Other: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols

Study type

Interventional

Funder types

Other

Identifiers

NCT07522216
JUST20240558

Details and patient eligibility

About

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

Full 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.

Enrollment

52 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

7-day aligner wearing protocol
Active Comparator group
Treatment:
Other: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols
14-day aligner wearing protocol
Active Comparator group
Treatment:
Other: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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