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OpenTrials
Active, Not Recruiting

NCT Number: NCT07522216

Effect of Clear Aligner Wear Protocol on External Root Resorption

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

postgraduate orthodontic clinics at JUST

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Root resorption

    Time frame: 6 months

    Peri-apical radiographs will be taken before and after the treatment, tooth root length will be measured before and after treatment from the radiographs

Secondary outcomes

  1. Pain perception

    Time frame: After 24 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months

    Pain perception will be measured in the two groups

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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