Anterior OpenbiteSPaTARNCT04419805
Single Palatal Temporary Anchorage Device for Anterior Open Bite
A study testing Single Palatal TAD and Two buccal TADs in people with Anterior Openbite, run by University of Dundee at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Anterior Openbite
- What is being tested?
- Single Palatal TAD and Two buccal TADs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial
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
Read the 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
- Conditions
- Anterior Openbite
- Being tested
- Single Palatal TAD, Two buccal TADs
- Keywords
- Orthodontics, Temporary Anchorage Device, Anterior Open Bite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Palatal TADDevice
A single mini-screw inserted in the mid-palate
Two buccal TADsDevice
Two buccal TADs inserted in the upper jaw
| Study group | Role | What they receive |
|---|---|---|
| Single Palatal TAD | Experimental | Single Palatal TAD for orthodontic molar intrusion Receives: Device: Single Palatal TAD |
| Two buccal TADs | Experimental | Two buccal TADs for orthodontic molar intrusion Receives: Device: Two buccal TADs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molar intrusion
Amount of upper molar intrusion measured in mms on cephalometric radiograph
Measured: 9-12 months after treatment commences
Secondary outcomes (2)
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
Measured: 9-12 months after treatment commences
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)
Measured: 9-12 months after treatment commences
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Apr 2021
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior OpenbiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised parallel 2 group clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Mossey, University of Dundee
- Investigators
- Peter Mossey, BDS, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419805
- Sponsor's protocol ID
- 2-054-19
- Acronym
- SPaTAR
- Status last verified
- Apr 2026
- First submitted
- 29 May 2020
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27864320
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04419805
- Acronym / sponsor ID
- SPaTAR / 2-054-19
- Conditions
- Anterior Openbite
- Keywords
- Orthodontics, Temporary Anchorage Device, Anterior Open Bite
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised parallel 2 group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Single Palatal TAD | Experimental | Device: Single Palatal TADSingle Palatal TAD for orthodontic molar intrusion |
| Two buccal TADs | Experimental | Device: Two buccal TADsTwo buccal TADs for orthodontic molar intrusion |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Palatal TADA single mini-screw inserted in the mid-palate | Device | Single Palatal TAD |
| Two buccal TADsTwo buccal TADs inserted in the upper jaw | Device | Two buccal TADs |
Primary outcome
Molar intrusion
Time frame: 9-12 months after treatment commences
Amount of upper molar intrusion measured in mms on cephalometric radiograph
2 secondary outcomes
Overbite (vertical overlap of anterior teeth)
Time frame: 9-12 months after treatment commences
Patient Experience
Time frame: 9-12 months after treatment commences
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 27864320Yassir 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.
- Individual participant dataSharing planned: No
Related trials for Anterior Openbite
Not yet recruiting
Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite
Open Bite, Malocclusion Class I
Recruiting
Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite
Open Bite
RecruitingObservational study
Stability of Orthodontic Treatment of Anterior Open-bite
Open Bite
Recruiting
Treatment Effects of Vertical Holding Appliance in Comparison to Zachrisson Transpalatal Arch on Anterior Open Bite Correction
Anterior Open Bite in Mixed Dentition
Active, not recruiting
Anterior Open Bite Closure by Clear Aligners Versus Fixed Appliances in Adult Patients With Skeletal Open Bite: A Randomized Clinical Trial.
Skeletal Open Bite, Open Bite
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Mossey, BDS principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Palatal TAD and Two buccal TADs in people with Anterior Openbite, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molar intrusion (time frame: 9-12 months after treatment commences). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04419805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.