Observational Comparison of Tooth-borne, Bone-borne and Hybrid Distraction Following SARPE. (SARPE)

April 19, 2021 updated by: Oliver da Costa Senior, ZOL
The investigators will perform a prospective, non-randomized observational study. The aim of this study is to evaluate stability of tooth-borne, bone-borne and hybrid expansion following SARPE by using data collected according to the existing SARPE follow-up protocol. The insights of this study might elucidate the preferred expansion technique and improve surgical technique.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Maxillary transverse discrepancy (MTD) is a difficult deformity to correct. In skeletal immature patients, an orthopedic-orthodontic expansion is the preferred treatment strategy. In case of a skeletal mature patient, a surgical treatment should be considered. A Surgically assisted Rapid Palatal Expansion (SARPE) procedure is a common surgical treatment for MTD in skeletal mature patients. In this procedure the skeletally mature, maxillary sutures are surgically reopened. One week postoperatively, the patient will activate the expander appliance. There are three widely-used expander appliances: tooth-borne, bone-borne and hybrid expanders. The use of the expander appliance is based on surgeon and referring orthodontist's common practice and preference. A tooth-borne expander is an appliance which is supported by the teeth and bridges the palate. A bone-borne expander is surgically placed at the level of the palate during SARPE surgery. Hybrid expansion is a combination of tooth-borne and bone-borne expansion. These appliances progressively widen the maxilla by daily activation of the distractor. The activation is stopped when the surgeon and/or referring orthodontist judge that the maxilla is sufficiently expanded. However, historical research with the use of cast model's and 2D posteroanterior cephalograms suggest that this expansion is not stable. With the emergence of 3D Cone-Beam Computed Tomography (CBCT) and its appliance as standard of care for pre-operative diagnosis and postoperative follow-up, stability and complications can be assessed more accurately. The goal of this study is to prospectively evaluate stability following SARPE, by analyzing the clinical and radiological data collected according to the existing clinical SARPE follow-up protocol. The secondary outcome is to evaluate complications following the three distractors.

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.
Observational

Enrollment (Anticipated)

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.
90

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing SARPE surgery due to maxillary transverse discrepancy

Description

Inclusion Criteria:

  • Maxillary transverse discrepancy
  • Skeletal mature patients
  • SARPE treatment is indicated

Exclusion Criteria:

  • Patients with a syndrome with an influence on head-and-neck morphology (such as Apert, Crouzon syndrome)
  • Cleft patients

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Tooth-borne distractor
Maxillary distraction with the use of a tooth-borne distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery.
Device: maxillary distractor
the type of maxillary distractor: tooth-borne, bone-borne or hybrid distractor
Bone-borne distractor
Maxillary distraction with the use of a bone-borne distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery.
Device: maxillary distractor
the type of maxillary distractor: tooth-borne, bone-borne or hybrid distractor
Hybrid distractor
Maxillary distraction with the use of a hybrid distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery.
Device: maxillary distractor
the type of maxillary distractor: tooth-borne, bone-borne or hybrid distractor

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
Measure Description
Time Frame
Stability
Time Frame: 1 year postoperatively
Stability of the maxillary expansion following SARPE. The stability will be evaluated by comparing the CBCT imaging which is taken at the time of maximal transversal maxillary expansion with the CBCT taken one year postoperatively. Width between the mesiobuccal cusps of the first molars and width between the cusps of the canines is measured. Moreover the width of the apertura piriformis and between the palatal foramen is examined in order to evaluate skeletal stability. This allows calculation of the dental and skeletal stability following SARPE.
1 year postoperatively

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
Complications
Time Frame: 1 year postoperatively
Complications following SARPE surgery are examined. Anamnestic, clinical and radiographic information is examined in order to determine postoperative complications. The following complications can be examined: postoperative bleeding, mucosal infection, maxillary sinus infection, palatal necrosis, oro-antral communication, gingival recession, tooth discoloration, bone resorption, malunion, nonunion, root resorption, loss of teeth, mechanical failure of the distractor, asymmetric expansion, lacrimation.
1 year postoperatively

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.
ZOL

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 (Anticipated)

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.
May 1, 2021

Primary Completion (Anticipated)

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.
December 31, 2023

Study Completion (Anticipated)

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.
December 31, 2023

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).
December 1, 2020

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.
December 15, 2020

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.
December 17, 2020

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.
April 20, 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.
April 19, 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.
April 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.
  • CTU2020095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

On request

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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