Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs

May 11, 2021 updated by: Aron Aliaga-Del Castillo, University of Sao Paulo

Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs: a Randomized Clinical Trial.

This study compares the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients. Half of participants will be treated with bonded spurs associated with build-ups, while the other half will be treated with conventional bonded spurs.

The null hypothesis to be tested is that there are no differences for the dentoalveolar and skeletal effects between the two protocols.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Anterior open bite is commonly related with lower anterior face height increase. Some early treatment protocols use appliances that control deleterious habits associated to appliances that produce control of the vertical dimension. Usually, these appliances (chincup, removable orthopedics) depend on patient's collaboration. Recently, the efficiency and stability of anterior open bite treatment with resin blocks bonded to the posterior teeth (build-ups) associated with fixed orthodontic appliances was described. They could be considered as a promissory alternative for vertical control during anterior open bite treatment. Then, it could be thought that the association of bonded spurs with posterior build-ups, instead of chincup, would produce vertical control during anterior open bite early treatment without the need of patient collaboration. Therefore, the aim of this study is to compare the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients.

For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. Fifty patients between 7 and 11 years old diagnosed with anterior open bite greater than 1 mm will be prospective and randomly allocated in one of the two study group. The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups. Control group will consist of 25 patients treated with conventional bonded spurs.

Lateral radiographs and digital dental models will be obtained at the beginning (T1), 12 months after treatment (T2), and 24 months after treatment (T3). Dentoalveolar and skeletal variables will be evaluated from the lateral radiographs in the Dolphin® software. Dental casts will be analyzed with the Orthoanalyzer® software to evaluate dentoalveolar anterior vertical development, posterior teeth inclinations and arch dimensions. Superimposition of digital dental models will be performed to evaluate the relative three-dimensional dentoalveolar changes on the maxillary and mandibular arches. Discomfort, pain and quality of life will be evaluated using questionnaires.

After verifying the normal distribution, intergroup comparisons (T1 vs T2 and T1 vs T3) will be performed with t test and intragroup comparisons with dependent t test. Results will be considered statistically significant at P<0.05.

The possible harms that could appear with these therapies are related to temporary tongue discomfort during the first days after the installation of the appliances. Patients and parents will be informed that is it normal. Although it has been reported that the discomfort is temporary and transitory and usually patients adapted to the treatment after 3-5 days, patients or parents will be able to stop the treatment at any moment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Bauru, São Paulo, Brazil, 17012901
        • Bauru Dental School, University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 7 to 11 years old,
  • erupted permanent first permanent molars,
  • anterior open bite (AOB) greater than 1 mm,
  • maxillary and mandibular permanent central incisors fully erupted,
  • no or mild crowding,
  • without the need of maxillary expansion
  • Children in the first transitional period will be considered to be eligible for treatment when the maxillary lateral incisors are beginning to erupt and the maxillary central incisors still show an open bite

Exclusion Criteria:

  • previous orthodontic treatment,
  • craniofacial anomalies or syndromes,
  • tooth agenesis,
  • loss of permanent teeth,
  • severe crowding,
  • maxillary constriction or posterior crossbite

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bonded Spurs associated with posterior build-ups Group
The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups.
Device: Bonded Spurs associated with posterior build-ups
Twenty-five patients will be treated with bonded spurs associated with posterior build-ups. The cervical portion of the palatal surfaces of the maxillary incisors and the incisal portion of the lingual surfaces of the mandibular incisors will be pumiced, rinsed, dried, and acid etched with 37% phosphoric acid. The etched surfaces will be subsequently rinsed and carefully dried. Then, the spurs will be bonded using Transbond primer/adhesive. The positions for the spurs will be chose to prevent possible future occlusal interferences The spurs will be sharpened with a carborundum disk before bonding. In addition, posterior build-ups (resin blocks) will be cemented on the functional cusps of all maxillary posterior teeth. The treatment time will be 12 months. After this time, the posterior build ups will be removed and the bonded spurs will be maintained for 12 months more, as active retention.
Active Comparator: Conventional bonded spurs Group
Active comparator group will consist of 25 patients treated with conventional bonded spurs
Device: Conventional bonded spurs
Twenty-five patients will be treated only with bonded spurs. The bonding of the spurs will follow the same protocol described for the experimental group. The treatment time will be 12 months. After this time, the bonded spurs will be maintained for 12 months more, as active retention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overbite (mm)
Time Frame: 12 months
12 months
Gonial angle (º)
Time Frame: 12 months
12 months
Mandibular plane angle (º)
Time Frame: 12 months
12 months
Maxillary and mandibular molar vertical development (mm)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overbite (mm)
Time Frame: 24 months
24 months
Gonial angle (º)
Time Frame: 24 months
24 months
Mandibular plane angle (º)
Time Frame: 24 months
24 months
Maxillary and mandibular molar vertical development (mm)
Time Frame: 24 months
24 months
Maxillary and mandibular position (º)
Time Frame: 12 months
12 months
Maxillary and mandibular position (º)
Time Frame: 24 months
24 months
Maxillary and mandibular length (mm)
Time Frame: 12 months
12 months
Maxillary and mandibular length (mm)
Time Frame: 24 months
24 months
Mandibular ramus height (mm)
Time Frame: 12 months
12 months
Mandibular ramus height (mm)
Time Frame: 24 months
24 months
Sagittal skeletal discrepancy (º)
Time Frame: 12 months
12 months
Sagittal skeletal discrepancy (º)
Time Frame: 24 months
24 months
Facial axis angle (º)
Time Frame: 12 months
12 months
Facial axis angle (º)
Time Frame: 24 months
24 months
Maxillomandibular divergence angle (º)
Time Frame: 12 months
12 months
Maxillomandibular divergence angle (º)
Time Frame: 24 months
24 months
Palatal plane inclination (º)
Time Frame: 12 months
12 months
Palatal plane inclination (º)
Time Frame: 24 months
24 months
Anterior face height (mm)
Time Frame: 12 months
12 months
Anterior face height (mm)
Time Frame: 24 months
24 months
Posterior face height (mm)
Time Frame: 12 months
12 months
Posterior face height (mm)
Time Frame: 24 months
24 months
Lower anterior face height (mm)
Time Frame: 12 months
12 months
Lower anterior face height (mm)
Time Frame: 24 months
24 months
Overjet (mm)
Time Frame: 12 months
12 months
Overjet (mm)
Time Frame: 24 months
24 months
Maxillary and mandibular incisors Inclination (º)
Time Frame: 12 months
12 months
Maxillary and mandibular incisors Inclination (º)
Time Frame: 24 months
24 months
Maxillary and mandibular incisors position (mm)
Time Frame: 12 months
12 months
Maxillary and mandibular incisors position (mm)
Time Frame: 24 months
24 months
Maxillary and mandibular incisors height (mm)
Time Frame: 12 months
12 months
Maxillary and mandibular incisors height (mm)
Time Frame: 24 months
24 months
Nasolabial angle (º)
Time Frame: 12 months
12 months
Nasolabial angle (º)
Time Frame: 24 months
24 months
Upper lip inclination (º)
Time Frame: 12 months
12 months
Upper lip inclination (º)
Time Frame: 24 months
24 months
Upper and lower lip position (mm)
Time Frame: 12 months
12 months
Upper and lower lip position (mm)
Time Frame: 24 months
24 months
Interlabial gap (mm)
Time Frame: 12 months
12 months
Interlabial gap (mm)
Time Frame: 24 months
24 months
Maxillary and mandibular anterior dentoalveolar vertical development (mm)
Time Frame: 12 months
12 months
Maxillary and mandibular anterior dentoalveolar vertical development (mm)
Time Frame: 24 months
24 months
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
Time Frame: 12 months
12 months
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
Time Frame: 24 months
24 months
Maxillary and mandibular inter-first permanent molar distances (mm)
Time Frame: 12 months
12 months
Maxillary and mandibular inter-first permanent molar distances (mm)
Time Frame: 24 months
24 months
Maxillary and mandibular inter-canine distances (mm)
Time Frame: 12 months
12 months
Maxillary and mandibular inter-canine distances (mm)
Time Frame: 24 months
24 months
Maxillary and mandibular arch perimeters (mm)
Time Frame: 12 months
12 months
Maxillary and mandibular arch perimeters (mm)
Time Frame: 24 months
24 months
Maxillary and mandibular arch lengths (mm)
Time Frame: 12 months
12 months
Maxillary and mandibular arch lengths (mm)
Time Frame: 24 months
24 months
Palatal depth (mm)
Time Frame: 12 months
12 months
Palatal depth (mm)
Time Frame: 24 months
24 months
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
Time Frame: 12 months
12 months
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
Time Frame: 24 months
24 months
Discomfort and pain intensity evaluated with questionnaires
Time Frame: 1 month
A 10-cm Visual Analog Scale will be used, where "0-cm" is the minimum score indicating nor discomfort or pain intensity and "10-cm" is the maximum score denoting the greatest discomfort or pain intensity.
1 month
Discomfort and pain intensity evaluated with questionnaires
Time Frame: 12 months
A 10-cm Visual Analog Scale will be used, where "0-cm" is the minimum score indicating nor discomfort or pain intensity and "10-cm" is the maximum score denoting the greatest discomfort or pain intensity.
12 months
Discomfort and pain intensity evaluated with questionnaires
Time Frame: 24 months
A 10-cm Visual Analog Scale will be used, where "0-cm" is the minimum score indicating nor discomfort or pain intensity and "10-cm" is the maximum score denoting the greatest discomfort or pain intensity.
24 months
Parent´s perception of children discomfort and pain intensity evaluated with questionnaires
Time Frame: 1 month
A 10-cm Visual Analog Scale will be used, where "0-cm" is the minimum score indicating nor discomfort or pain intensity and "10-cm" is the maximum score denoting the greatest discomfort or pain intensity.
1 month
Quality of life evaluation with questionnaires
Time Frame: 12 months
Oral health related-quality of life evaluation will be performed with the Child Perceptions Questionnaire (CPQ8-10). The questionnaire contains 25 items distributed in four domains: oral symptoms, functional limitations, emotional wellbeing and social wellbeing. The items assess the frequency of the events that occurs in the four weeks previous to the application of the questionnaire. A 5-point Likert scale is used with the options: Never (0), Once/twice (1), Sometimes (2), Often (3), and Every day/almost every day (4). The CPQ8-10 scores are obtained by summing all item scores. The total score ranges from "0" indicating no impact of oral condition on quality of life, to "100" indicating maximal impact of oral condition on quality of life.
12 months
Quality of life evaluation with questionnaires
Time Frame: 24 months
Oral health related-quality of life evaluation will be performed with the Child Perceptions Questionnaire (CPQ8-10). The questionnaire contains 25 items distributed in four domains: oral symptoms, functional limitations, emotional wellbeing and social wellbeing. The items assess the frequency of the events that occurs in the four weeks previous to the application of the questionnaire. A 5-point Likert scale is used with the options: Never (0), Once/twice (1), Sometimes (2), Often (3), and Every day/almost every day (4). The CPQ8-10 scores are obtained by summing all item scores. The total score ranges from "0" indicating no impact of oral condition on quality of life, to "100" indicating maximal impact of oral condition on quality of life.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 68551617.8.0000.5417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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