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

Apical Root Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870463
• Other study ID #: Estrella1*
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: October 22, 2023

Study information

• Verified date: October 2022
• Source: Universidad Complutense de Madrid
• Contact: Alejandro Iglesias Linares
• Phone: 0034 636705246
• Email: aleigl01[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 245
• Est. completion date: October 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Root Resorption
• Root Resorption

Intervention

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)

Locations

Country	Name	City	State
Spain	Facultad de Odontología de la Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)