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

Primary Purpose

Apical Root Resorption

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Maxillary and mandibular Cone Beam Computed Tomography record
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Apical Root Resorption

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Facultad de Odontología de la Universidad Complutense de MadridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gold Standard Group

Intervention Group

Arm Description

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)

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))

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Root volumen
Measure of the total volume of each root at momento of treatment (T0, T1 and T2)
Root surface area
Measure of the outer surface of the root dentine at momento of treatment (T0, T1 and T2)

Full Information

First Posted
April 22, 2021
Last Updated
November 2, 2022
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04870463
Brief Title
Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress
Official Title
Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress: Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
June 22, 2023 (Anticipated)
Study Completion Date
October 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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: 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Root Resorption

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial of two parallel arms, that analysed the possible superiority of one treatment compared to the gold standard of reference
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
245 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gold Standard Group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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))
Intervention Type
Procedure
Intervention Name(s)
Maxillary and mandibular Cone Beam Computed Tomography record
Intervention Description
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)
Primary Outcome Measure Information:
Title
Difference of volume of the apical portion of the root
Description
Measure of the 5 more apical mm3 of the root at each moment of treatment (T0, T1 and T2)
Time Frame
Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)
Secondary Outcome Measure Information:
Title
Root volumen
Description
Measure of the total volume of each root at momento of treatment (T0, T1 and T2)
Time Frame
Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)
Title
Root surface area
Description
Measure of the outer surface of the root dentine at momento of treatment (T0, T1 and T2)
Time Frame
Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Study Population: patients undergoing orthodontic treatment in Orthodontic Department at Dental School of Universidad Complutense de Madrid. Inclusion Criteria: Completed permanent dentition (third molars are excluded) Completed root formation Need of orthodontic treatment Exclusion Criteria: Tooth agenesis in the anterior region (incisors) Included or ankylosed teeth in the anterior region (incisors) Periodontal pocket >3 mm in any anterior teeth (incisors) Need of a combined surgical and orthodontic treatment Root resorptions observed at the initial CBCT (in more than 3 teeth) Delay of the treatment due to a external reason or complication during treatment Systemic disease or cranio-facial malformation Tooth fracture or restoration in the anterior region (incisors) at the beginning of treatment Problems from roots such as lacerated root, trauma or fractures during treatment 10 Severe occlusal attrition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Iglesias Linares
Phone
0034 636705246
Email
aleigl01@ucm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Estrella Navarro Fraile
Phone
0034 656814385
Email
esnava01@ucm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Iglesias Linares
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Odontología de la Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estrella Navarro
Phone
656814385
Ext
0034
Email
esnava01@ucm.es

12. IPD Sharing Statement

Plan to Share IPD
No

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

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