Comprehensive Outcomes of Palatal TSADs Treatment

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?

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 Overview

• Status: Completed
• Conditions: Malocclusions
• Intervention / Treatment: Device: Palatal temporary skeletal anchorage devices

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Nowy Sącz, Poland, 33-300
    • Ortostrefa Orthodontic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Palatal Temporary Skeletal Anchorage Devices

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-treatment) and through completion of orthodontic treatment (up to 24 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Periprocedural (Day 0, immediately after placement of mini-screws using the surgical guide).

Collaborators and Investigators

• Sponsor: Hospital of the Ministry of Interior, Kielce, Poland

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): September 10, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: CT/2025/2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No