Apical Root ResorptionNCT04870463
Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress
A study testing Maxillary and mandibular Cone Beam Computed Tomography record in people with Apical Root Resorption, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Apical Root Resorption
- What is being tested?
- Maxillary and mandibular Cone Beam Computed Tomography record
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 13 Sep 2021to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Completed permanent dentition (third molars are excluded)
- Completed root formation
- Need of orthodontic treatment
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Odontología de la Universidad Complutense de Madrid
Madrid, 28040
About this study
Official title: Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress: Randomised Clinical Trial
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.
Read the 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.
- Conditions
- Apical Root Resorption
- Being tested
- Maxillary and mandibular Cone Beam Computed Tomography record
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary and mandibular Cone Beam Computed Tomography recordProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Gold Standard Group | Active comparator | 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) Receives: Procedure: Maxillary and mandibular Cone Beam Computed Tomography record |
| Intervention Group | Experimental | 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)) Receives: Procedure: Maxillary and mandibular Cone Beam Computed Tomography record |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)
Secondary outcomes (2)
Root volumen
Measure of the total volume of each root at momento of treatment (T0, T1 and T2)
Measured: Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)
Root surface area
Measure of the outer surface of the root dentine at momento of treatment (T0, T1 and T2)
Measured: Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start13 Sep 2021
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical Root ResorptionStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Iglesias Linares, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870463
- Sponsor's protocol ID
- Estrella1*
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04870463
- Acronym / sponsor ID
- Estrella1*
- Conditions
- Apical Root Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial of two parallel arms, that analysed the possible superiority of one treatment compared to the gold standard of reference
| Arm | Type | Receives |
|---|---|---|
| Gold Standard Group | Active comparator | Procedure: Maxillary and mandibular Cone Beam Computed Tomography recordPatients 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) |
| Intervention Group | Experimental | Procedure: Maxillary and mandibular Cone Beam Computed Tomography recordPatients 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)) |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Completed permanent dentition (third molars are excluded)
- Completed root formation
- Need of orthodontic treatment
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillary and mandibular Cone Beam Computed Tomography recordA 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) | Procedure or surgery | Gold Standard Group, Intervention Group |
Primary outcome
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)
2 secondary outcomes
Root volumen
Time frame: Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)
Root surface area
Time frame: Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Apical Root Resorption
Not yet recruiting
Comparison of Root Resorption in Modified Corticotomy-Assisted and Conventional Canine Retraction
External Apical Root Resorption in Maxillary Canines During Orthodontic Retraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Iglesias Linares principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary and mandibular Cone Beam Computed Tomography record in people with Apical Root Resorption, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.