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

Overview

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.

Full Title of Study: “Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress: Randomised Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 22, 2023

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

  • 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)

Arms, Groups and Cohorts

  • 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)
  • 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))

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Complutense de Madrid
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alejandro Iglesias Linares, Principal Investigator, Universidad Complutense de Madrid
  • Overall Contact(s)
    • Alejandro Iglesias Linares, 0034 636705246, aleigl01@ucm.es

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.