Single Palatal Temporary Anchorage Device for Anterior Open Bite (SPaTAR)
Primary Purpose
Anterior Openbite
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Single Palatal TAD
Two buccal TADs
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Openbite focused on measuring Orthodontics, Temporary Anchorage Device, Anterior Open Bite
Eligibility Criteria
Inclusion Criteria:
- Patients with AOB of 1-6mm
- Aged between (12 and 40 years).
- Able to consent.
- Patient due to undergo orthodontic treatment with fixed orthodontic braces.
Exclusion Criteria:
- Patient has previously had upper first permanent molar extraction.
- Patient with congenital cleft of lip and/or palate or any other craniofacial anomalies.
- Patient with bone disease or taking medications that affect the bone quality or nature.
- Patient with an active digit sucking habit.
- Pregnant or breastfeeding women
Sites / Locations
- Dundee Dental HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single Palatal TAD
Two buccal TADs
Arm Description
Single Palatal TAD for orthodontic molar intrusion
Two buccal TADs for orthodontic molar intrusion
Outcomes
Primary Outcome Measures
Molar intrusion
Amount of upper molar intrusion measured in mms on cephalometric radiograph
Secondary Outcome Measures
Overbite (vertical overlap of anterior teeth)
Change in overbite (vertical overlap of anterior teeth) measured clinically directly from the teeth with a ruler and on 3D dental scans using 3D analysis software, both in mms
Patient Experience
Patient experience with the use of temporary anchorage devices for intrusion by validated questionnaire which uses 3 or 4 point Likert Scales for a range of questions across relevant doamins. Depending on the question the scales are 'Improved/Same/Worse/Much worse' or 'Not at all / A little / A lot' or 'I do more / no difference / I do less' (Yassir et al 2017)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04419805
Brief Title
Single Palatal Temporary Anchorage Device for Anterior Open Bite
Acronym
SPaTAR
Official Title
Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants are orthodontic patients with anterior open bite (AOB) malocclusion. These patients will be treated by molar intrusion achieved using one of two interventions, either orthodontic fixed appliances incorporating a single palatal Temporary Anchorage Device (TAD) or orthodontic fixed appliances incorporating two buccal TADs
Detailed Description
Participants will be recruited from those attending Dundee Dental Hospital Orthodontic Department and those currently awaiting treatment. Those that meet the inclusion and exclusion criteria will be invited to participate. After obtaining consent they will be allocated to receive one of the two interventions. The two interventions represent the currently available options for treatment of mild - moderate (1-6mm) anterior open bite in the Orthodontic Department and as such patients will be receiving routine treatment regardless of the arm they are randomised to. In order to assess the more effective intervention additional records will be taken during the treatment involving additional cephalometric radiographs, additional intra-oral scans or dental impressions (See later for details). Primary outcome is at the end of intrusion with TADs after 9-12 months, but participants will be followed until completion of treatment for the secondary outcome of stability of intrusion and overbite correction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Openbite
Keywords
Orthodontics, Temporary Anchorage Device, Anterior Open Bite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised parallel 2 group clinical trial
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be blind to allocation
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Palatal TAD
Arm Type
Experimental
Arm Description
Single Palatal TAD for orthodontic molar intrusion
Arm Title
Two buccal TADs
Arm Type
Experimental
Arm Description
Two buccal TADs for orthodontic molar intrusion
Intervention Type
Device
Intervention Name(s)
Single Palatal TAD
Intervention Description
A single mini-screw inserted in the mid-palate
Intervention Type
Device
Intervention Name(s)
Two buccal TADs
Intervention Description
Two buccal TADs inserted in the upper jaw
Primary Outcome Measure Information:
Title
Molar intrusion
Description
Amount of upper molar intrusion measured in mms on cephalometric radiograph
Time Frame
9-12 months after treatment commences
Secondary Outcome Measure Information:
Title
Overbite (vertical overlap of anterior teeth)
Description
Change in overbite (vertical overlap of anterior teeth) measured clinically directly from the teeth with a ruler and on 3D dental scans using 3D analysis software, both in mms
Time Frame
9-12 months after treatment commences
Title
Patient Experience
Description
Patient experience with the use of temporary anchorage devices for intrusion by validated questionnaire which uses 3 or 4 point Likert Scales for a range of questions across relevant doamins. Depending on the question the scales are 'Improved/Same/Worse/Much worse' or 'Not at all / A little / A lot' or 'I do more / no difference / I do less' (Yassir et al 2017)
Time Frame
9-12 months after treatment commences
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with AOB of 1-6mm
Aged between (12 and 40 years).
Able to consent.
Patient due to undergo orthodontic treatment with fixed orthodontic braces.
Exclusion Criteria:
Patient has previously had upper first permanent molar extraction.
Patient with congenital cleft of lip and/or palate or any other craniofacial anomalies.
Patient with bone disease or taking medications that affect the bone quality or nature.
Patient with an active digit sucking habit.
Pregnant or breastfeeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Bearn, BDS
Phone
01382385024
Email
d.bearn@dundee.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Vera Nuritova, PhD
Phone
01382383877
Email
TASCgovernance@dundee.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Mossey, BDS
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dundee Dental Hospital
City
Dundee
ZIP/Postal Code
DD1 4HR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David R Bearn, BDS
Phone
01382381604
Email
d.bearn@dundee.ac.uk
First Name & Middle Initial & Last Name & Degree
Omar Alshaibi, BDS
Phone
07762379239
Email
o.alshaibi@dundee.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27864320
Citation
Yassir YA, McIntyre GT, Bearn DR. Three questionnaires to assess the perception of fixed orthodontic therapy before, during and after treatment: validity and reliability. Eur J Orthod. 2017 Aug 1;39(4):402-410. doi: 10.1093/ejo/cjw076.
Results Reference
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Single Palatal Temporary Anchorage Device for Anterior Open Bite
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