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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04870463
Enrollment
60
Registered
2021-05-03
Start date
2021-09-13
Completion date
2025-06-24
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Root Resorption

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.

Interventions

PROCEDUREMaxillary 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)

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Randomized clinical trial of two parallel arms, that analysed the possible superiority of one treatment compared to the gold standard of reference

Eligibility

Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Difference of volume of the apical portion of the rootBaseline/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

MeasureTime frameDescription
Root volumenBaseline/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 areaBaseline/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)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026