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

NCT ID: NCT04870463

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2025-06-24

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.

Conditions

Apical Root Resorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Maxillary and mandibular Cone Beam Computed Tomography record

Intervention Type: 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)

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))

Group Type: EXPERIMENTAL

Maxillary and mandibular Cone Beam Computed Tomography record

Intervention Type: 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)

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejandro Iglesias Linares

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

Facultad de Odontología de la Universidad Complutense de Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

Estrella1*

Identifier Type: -

Identifier Source: org_study_id