Comprehensive Outcomes of Palatal TSADs Treatment

NCT07311473 | Completed

• 1 other identifier: CT/2025/2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Malocclusions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence and Types of Complications Associated with Orthodontic Treatment Using Palatal TSADs

  Periprocedural period and up to 8 weeks post TSAD insertion.

• Patient-Reported Quality of Life During TSAD-Supported Use of the Palatal Appliance

  Baseline (Day 0, day of appliance placement) through 8 weeks post-insertion.

• Accuracy of Patient-Specific Surgical Guides for Palatal Mini-Screw Placement

  Periprocedural (Day 0, immediately after placement of mini-screws using the surgical guide).

Study Arms (1)

Palatal Temporary Skeletal Anchorage Devices

EXPERIMENTAL

Device: Palatal temporary skeletal anchorage devices

Interventions

Palatal temporary skeletal anchorage devices DEVICE

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.

Palatal Temporary Skeletal Anchorage Devices

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Ortostrefa Orthodontic Clinic

Nowy Sącz, 33-300, Poland

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 31, 2025
• Study Start: January 3, 2023
• Primary Completion: September 10, 2025
• Study Completion: October 21, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

PL (1)