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

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ClinicalTrials.gov Identifier: NCT04670211
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Oliver da Costa Senior, ZOL

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Malocclusion Device: maxillary distractor

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Observational Comparison of Tooth-borne, Bone-borne and Hybrid Distraction Following SARPE.
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing SARPE surgery due to maxillary transverse discrepancy
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Oliver da Costa Senior, dr. Oliver da Costa Senior (principle investigator), ZOL
ClinicalTrials.gov Identifier: NCT04670211    
Other Study ID Numbers: CTU2020095
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: On request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oliver da Costa Senior, ZOL:
SARPE
distraction osteogenesis
transverse maxillary hypoplasia
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases