MalocclusionsNCT07311473
Comprehensive Outcomes of Palatal TSADs Treatment
A study testing Palatal temporary skeletal anchorage devices in people with Malocclusions, run by Hospital of the Ministry of Interior, Kielce, Poland at 1 site in Poland.
Trial summary
This study aims to evaluate clinical outcomes, patient-reported quality of life, the precision of surgical guides used for placing orthodontic mini-screws, and potential complications associated with the use of palatal temporary skeletal anchorage devices (TSADs) in orthodontically treated patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malocclusions
- What is being tested?
- Palatal temporary skeletal anchorage devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jan 2023to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of a malocclusion requiring palatal temporary skeletal anchorage devices (TSADs)
- No previous treatment involving TSADs
- Lack of systemic comorbidities
- Signed informed consent (and parental consent for minors)
Who cannot join
- Presence of uncontrolled systemic diseases or conditions that contraindicate orthodontic treatment or the placement of mini-screws
- Poor oral hygiene
- Allergies to materials used in mini-screws or associated orthodontic appliances
- Lack of patient consent for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Evaluation of Treatment Outcomes in Patients Treated With Palatal Temporary Skeletal Anchorage Devices
This study aims to evaluate clinical outcomes, patient-reported quality of life, the precision of surgical guides used for placing orthodontic mini-screws, and potential complications associated with the use of palatal temporary skeletal anchorage devices (TSADs) in orthodontically treated patients. The main questions it aims to answer are:
- What is the clinical effectiveness of palatal TSADs in orthodontic treatment outcomes?
- How do palatal TSADs affect the quality of life in orthodontic patients?
- How accurately do surgical guides transfer the digitally planned positions of mini-screws to their actual positions?
- What are the complications associated with the use of palatal TSADs in orthodontic treatment?
Read more
Participants will:
- Receive orthodontic treatment involving the placement of palatal TSADs
- Complete validated, standardized questionnaires assessing quality of life
- Be evaluated for skeletal and dental changes and monitored for clinical and technical complications throughout the course of treatment
- Conditions
- Malocclusions
- Being tested
- Palatal temporary skeletal anchorage devices
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal temporary skeletal anchorage devicesDevice
Participants will receive orthodontic treatment involving the placement of palatal TSADs. Prior to the procedure, a cone-beam computed tomography (CBCT) scan will be obtained. Local anesthesia (0.2-0.5 mL) will be administered, after which two 2-mm diameter mini-implants will be inserted using a patient-specific surgical guide, and a palatal appliance will be positioned.
| Study group | Role | What they receive |
|---|---|---|
| Palatal Temporary Skeletal Anchorage Devices | Experimental | Not described Receives: Device: Palatal temporary skeletal anchorage devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maxillary width before and after TSAD-supported orthodontic treatment
This primary outcome measure assesses changes in palatal width (in millimeters) among patients undergoing orthodontic treatment with temporary skeletal anchorage devices (TSADs). Measurements of palatal width will be conducted at two distinct time points: at baseline (prior to initiation of orthodontic treatment) and upon completion of the treatment. Measurements will be conducted using imaging techniques.
Measured: Baseline (pre-treatment) and through completion of orthodontic treatment (up to 24 months).
Secondary outcomes (3)
Incidence and Types of Complications Associated with Orthodontic Treatment Using Palatal TSADs
This secondary outcome measure is designed to evaluate the number, frequency, and types of complications specifically associated with TSADs and the palatal appliance during the periprocedural period and up to 8 weeks following TSAD insertion. The analysis will consider both the quantitative occurrence and qualitative characteristics of these early complications, providing insight into the short-term safety and clinical tolerability of TSAD-supported orthodontic therapy.
Measured: Periprocedural period and up to 8 weeks post TSAD insertion.
Patient-Reported Quality of Life During TSAD-Supported Use of the Palatal Appliance
This secondary outcome measure evaluates patient-reported quality of life during the adaptation period to the palatal appliance supported by TSADs. On the day of appliance placement, patients will receive a self-administered questionnaire designed to assess subjective experiences related to wearing the appliance. The questionnaire includes, among others, items addressing discomfort or pain, difficulties during the initial adaptation phase, speech disturbances, or eating challenges. Completed questionnaires will be collected by the investigator at the subsequent orthodontic follow-up visit. The analysis will provide insight into the overall impact of the TSAD-supported palatal appliance on daily functioning.
Measured: Baseline (Day 0, day of appliance placement) through 8 weeks post-insertion.
Accuracy of Patient-Specific Surgical Guides for Palatal Mini-Screw Placement
This secondary outcome measure evaluates the precision of surgical guides used for the placement of palatal mini-screws during orthodontic treatment. Accuracy will be assessed by comparing the digitally planned positions of the mini-screws with their actual positions.
Measured: Periprocedural (Day 0, immediately after placement of mini-screws using the surgical guide).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start3 Jan 2023
- Primary completion10 Sep 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital of the Ministry of Interior, Kielce, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311473
- Sponsor's protocol ID
- CT/2025/2
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of Treatment Outcomes in Patients Treated With Palatal Temporary Skeletal Anchorage Devices
- ClinicalTrials.gov ID
- NCT07311473
- Acronym / sponsor ID
- CT/2025/2
- Conditions
- Malocclusions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital of the Ministry of Interior, Kielce, PolandUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 31 Dec 2025 (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.
This study aims to evaluate clinical outcomes, patient-reported quality of life, the precision of surgical guides used for placing orthodontic mini-screws, and potential complications associated with the use of palatal temporary skeletal anchorage devices (TSADs) in orthodontically treated patients. The main questions it aims to answer are:
- What is the clinical effectiveness of palatal TSADs in orthodontic treatment outcomes?
- How do palatal TSADs affect the quality of life in orthodontic patients?
- How accurately do surgical guides transfer the digitally planned positions of mini-screws to their actual positions?
- What are the complications associated with the use of palatal TSADs in orthodontic treatment?
Participants will:
- Receive orthodontic treatment involving the placement of palatal TSADs
- Complete validated, standardized questionnaires assessing quality of life
- Be evaluated for skeletal and dental changes and monitored for clinical and technical complications throughout the course of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palatal Temporary Skeletal Anchorage Devices | Experimental | Device: Palatal temporary skeletal anchorage devices |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of a malocclusion requiring palatal temporary skeletal anchorage devices (TSADs)
- No previous treatment involving TSADs
- Lack of systemic comorbidities
- Signed informed consent (and parental consent for minors)
Key exclusion criteria (4 listed)
- Presence of uncontrolled systemic diseases or conditions that contraindicate orthodontic treatment or the placement of mini-screws
- Poor oral hygiene
- Allergies to materials used in mini-screws or associated orthodontic appliances
- Lack of patient consent for study participation
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 |
|---|---|---|
| Palatal temporary skeletal anchorage devicesParticipants will receive orthodontic treatment involving the placement of palatal TSADs. Prior to the procedure, a cone-beam computed tomography (CBCT) scan will be obtained. Local anesthesia (0.2-0.5 mL) will be administered, after which two 2-mm diameter mini-implants will be inserted using a patient-specific surgical guide, and a palatal appliance will be positioned. | Device | Palatal Temporary Skeletal Anchorage Devices |
Primary outcome
Change in maxillary width before and after TSAD-supported orthodontic treatment
Time frame: Baseline (pre-treatment) and through completion of orthodontic treatment (up to 24 months).
This primary outcome measure assesses changes in palatal width (in millimeters) among patients undergoing orthodontic treatment with temporary skeletal anchorage devices (TSADs). Measurements of palatal width will be conducted at two distinct time points: at baseline (prior to initiation of orthodontic treatment) and upon completion of the treatment. Measurements will be conducted using imaging techniques.
3 secondary outcomes
Incidence and Types of Complications Associated with Orthodontic Treatment Using Palatal TSADs
Time frame: Periprocedural period and up to 8 weeks post TSAD insertion.
Patient-Reported Quality of Life During TSAD-Supported Use of the Palatal Appliance
Time frame: Baseline (Day 0, day of appliance placement) through 8 weeks post-insertion.
Accuracy of Patient-Specific Surgical Guides for Palatal Mini-Screw Placement
Time frame: Periprocedural (Day 0, immediately after placement of mini-screws using the surgical guide).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatal temporary skeletal anchorage devices in people with Malocclusions, run by Hospital of the Ministry of Interior, Kielce, Poland at 1 site in Poland.
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 4 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: finished, as of the sponsor's last update on 31 Dec 2025. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in maxillary width before and after TSAD-supported orthodontic treatment (time frame: Baseline (pre-treatment) and through completion of orthodontic treatment (up to 24 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.