Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
150 participants
INTERVENTIONAL
2023-01-03
2025-10-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Palatal Temporary Skeletal Anchorage Devices
Palatal temporary skeletal anchorage devices
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Palatal temporary skeletal anchorage devices
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No previous treatment involving TSADs
* Lack of systemic comorbidities
* Signed informed consent (and parental consent for minors)
Exclusion Criteria
* Poor oral hygiene
* Allergies to materials used in mini-screws or associated orthodontic appliances
* Lack of patient consent for study participation
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital of the Ministry of Interior, Kielce, Poland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ortostrefa Orthodontic Clinic
Nowy Sącz, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CT/2025/2
Identifier Type: -
Identifier Source: org_study_id