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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Clear Aligner Therapy
• Intervention / Treatment: Other: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 22110
    • postgraduate orthodontic clinics at JUST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 7-day aligner wearing protocol	Other: Differnt 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)
Active Comparator: 14-day aligner wearing protocol	Other: Differnt 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root resorption	Peri-apical radiographs will be taken before and after the treatment, tooth root length will be measured before and after treatment from the radiographs	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	Pain perception will be measured in the two groups	After 24 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Root resorption; Aligner wearing protocol
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Resorption; Root Resorption
• Other Study ID Numbers: JUST20240558

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No