Effect of Clear Aligner Wear Protocol on External Root Resorption

N/AActive Not RecruitingNCT07522216

Jordan University of Science and Technology52 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Clear Aligner Therapy

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

postgraduate orthodontic clinics at JUST

Irbid, Jordan

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Pain perception

Pain perception will be measured in the two groups

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

Data from ClinicalTrials.gov

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