Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress

Not Applicable

Completed

• Conditions: Apical Root Resorption

• Registration Number: NCT04870463
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

The goal of this prospective clinical trial is to evaluate the possible superiority of a treatment compared to the gold standard of reference in Orthodontics.

Detailed Description

Apical external root resorption is defined as the loss of dental hard tissues such as dentine, cement and alveolar bone. This is considered an irrevocable effect associated to different factors, among which dental movement during orthodontic treatment is related.

This study suggest to compare root resorption after the use of two different types of alignment and levelling arches in orthodontics. Consecutive patients randomly chosen will be analysed after going through one of the two arches sequences:

1. Gold standard group: using arches that provide the same amount of force in all sections . 3M United® nickel-titanium arches (0.012, 0.014, 0.016 x 0.016, 0.020 x 0.020, 0.018 x 0.025 y 0.019 x 0.025)

2. Intervention group: using some arches that provide individual sectional forces for each dental group (incisors, premolars and molars). 3M United® nickel-titanium 0.012 and 0.014 arches and BioForce PLUS® arches (0.016 x 0.016, 0.020 x 0.020, 0.018 x 0.025 y 0.019 x 0.025).

All patients will be treated with multi-braces fixed appliances (0.022" technique and VictoryTM brackets).

Root resorption will be compared through CBCT (Cone Beam Computed Tomography) images made before the beginning of treatment (T0), after 8-9 months of the beginning of treatment (T1) and at the end of treatment (T2). Root resorption will be measured by the root volume and surface root morphology in each of the times scheduled.

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Study Start: 2021-09-13
• Status Verified: 2025-06
• Primary Completion: 2025-06-24
• Study Completion: 2025-06-24
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Completed permanent dentition (third molars are excluded)
2. Completed root formation
3. Need of orthodontic treatment

Exclusion Criteria

1. Tooth agenesis in the anterior region (incisors)
2. Included or ankylosed teeth in the anterior region (incisors)
3. Periodontal pocket >3 mm in any anterior teeth (incisors)
4. Need of a combined surgical and orthodontic treatment
5. Root resorptions observed at the initial CBCT (in more than 3 teeth)
6. Delay of the treatment due to a external reason or complication during treatment
7. Systemic disease or cranio-facial malformation
8. Tooth fracture or restoration in the anterior region (incisors) at the beginning of treatment
9. Problems from roots such as lacerated root, trauma or fractures during treatment 10 Severe occlusal attrition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference of volume of the apical portion of the root	Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)	Measure of the 5 more apical mm3 of the root at each moment of treatment (T0, T1 and T2)

Secondary Outcome Measures

Name	Time	Method
Root volumen	Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)	Measure of the total volume of each root at momento of treatment (T0, T1 and T2)
Root surface area	Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)	Measure of the outer surface of the root dentine at momento of treatment (T0, T1 and T2)

Trial Locations

Locations (1)

Facultad de Odontología de la Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain