Skip to main content
OpenTrials
Completed

NCT Number: NCT04870463

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Odontología de la Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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:

  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: No

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

Study Population: patients undergoing orthodontic treatment in Orthodontic Department at Dental School of Universidad Complutense de Madrid.

Inclusion criteria

  • Completed permanent dentition (third molars are excluded)
  • Completed root formation
  • Need of orthodontic treatment

Exclusion criteria

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

Treatment and study plan

Maxillary and mandibular Cone Beam Computed Tomography record

Procedure

A Cone Beam Computed Tomography image of each patient of each group at three different moments of the study (baseline/T0, 8-9 months of treatment/T1 and end of treatment/T2)

Primary outcomes

  1. Difference of volume of the apical portion of the root

    Time frame: 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 outcomes

  1. Root volumen

    Time frame: 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)

  2. Root surface area

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress: Randomised Clinical Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 3, 2021
Registry last updated
Jun 27, 2025

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.