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

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

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.

Study Overview

• Status: Completed
• Conditions: Apical Root Resorption
• Intervention / Treatment: Procedure: Maxillary and mandibular Cone Beam Computed Tomography record

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Facultad de Odontología de la Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gold Standard Group; Patients treated with multi-braces fixed appliances and a conventional sequence of aligning and levelling arches (Ni-Ti arches with the same force in all sections)	Procedure: Maxillary and mandibular Cone Beam Computed Tomography record; 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)
Experimental: Intervention Group; Patients treated with multi-braces fixed appliances and a different sequence of aligning and levelling arches (some arches provide individual forces for each group of teeth (incisors, premolars and molars))	Procedure: Maxillary and mandibular Cone Beam Computed Tomography record; 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Alejandro Iglesias Linares, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): June 24, 2025
• Study Completion (Actual): June 24, 2025

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Resorption; Root Resorption
• Other Study ID Numbers: Estrella1*

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No