Observational Comparison of Tooth-borne, Bone-borne and Hybrid Distraction Following SARPE.
SARPE
1 other identifier
observational
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Typical duration for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 20, 2021
April 1, 2021
2.7 years
December 1, 2020
April 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stability
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 Outcomes (1)
Complications
1 year postoperatively
Study Arms (3)
Tooth-borne distractor
Maxillary distraction with the use of a tooth-borne distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery.
Bone-borne distractor
Maxillary distraction with the use of a bone-borne distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery.
Hybrid distractor
Maxillary distraction with the use of a hybrid distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery.
Interventions
the type of maxillary distractor: tooth-borne, bone-borne or hybrid distractor
Eligibility Criteria
Patients undergoing SARPE surgery due to maxillary transverse discrepancy
You may qualify if:
- Maxillary transverse discrepancy
- Skeletal mature patients
- SARPE treatment is indicated
You may not qualify if:
- Patients with a syndrome with an influence on head-and-neck morphology (such as Apert, Crouzon syndrome)
- Cleft patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZOLlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr. Oliver da Costa Senior (principle investigator)
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 17, 2020
Study Start
May 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
April 20, 2021
Record last verified: 2021-04