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Clinical Trials/NCT05930054
NCT05930054CompletedNot Applicable

Dentoskeletal Changes In The Transverse Dimension Using Tooth Bone-Borne Vs. Bone-Borne Expansion Appliances: A Prospective, Randomized, Double-Blind Clinical Study With Cone-Beam Computed Tomography

TC Erciyes University3 sites in 1 country18 target enrollmentStarted: September 12, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
3
Primary Endpoint
Nasal Changes

Study Overview

Brief Summary

This study aimed to investigate the skeletal, dentoalveolar, and periodontal changes of tooth-bone-borne (TBB) and bone-borne (BB) appliances with identical miniscrew placement using cone-beam computed tomography (CBCT) in the post-pubertal growth spurt stage.

Detailed Description

Eighteen patients were divided into 2 groups: TBB group (n = 9, 16.11 ± 0.59 years of age) and BB group (n = 9, 15.33 ± 1.22 years of age). CBCT scans were obtained before treatment and after 3 months of expansion. Transverse skeletal and dental expansion, alveolar and tooth inclination, and buccal alveolar bone thickness were evaluated in maxillary first premolars and molars. Paired t tests and independent-sample t tests were used to compare the expansion appliances.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
14 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •With a unilateral or bilateral morphological lateral crossbite
  • •Whose first molars and premolars had completely erupted at pretreatment
  • •With maxillary constriction of more than 4 mm and less than 10 mm
  • •Who were going through the post-pubertal growth spurt stage based on hand-wrist radiographs

Exclusion Criteria

  • •craniofacial anomalies
  • •compliance problems
  • •systemic or genetic disease
  • •previous orthodontic treatment history

Arms & Interventions

tooth-bone-borne (TBB) group

Other

The TBB appliance was composed of a central expansion jackscrew (Dentarum), 4 tubes, 2 bands on the upper first molars to facilitate placement of the appliance, and 1.5-mm diameter stainless steel arms extending to the premolar teeth. Soldered stainless steel tubes (internal diameter: 2.0 mm; external diameter: 3.0 mm; length: 2.0 mm) served as guides for miniscrew placement. The size of the screws (PSM) was chosen as 1.8 mm in diameter and 11 mm in length, considering the 2 mm height of the tubes, 1 to 2 mm gap between the appliance and the palate surface, 1 to 2 mm gingiva thickness, and 5 to 6 mm length required for the bicortical placement of the screw in the bone.

Intervention: skeletal anchorage and rapid palatal expansion (Device)

bone-borne (BB) group

Other

The BB appliance was composed of a central expansion jackscrew, 4 tubes as described in TBB group, and less acrylic used around it to adjust its position. In order to carry it to the mouth after preparation on the cast model, essix was used, which also included the patient's teeth

Intervention: skeletal anchorage and rapid palatal expansion (Device)

Outcomes

Primary Outcomes

Nasal Changes

Time Frame: up to 1 year

Nasal Width:Distance between right and left inner lateral limits of nasal cavity, parallel to the base of the nasal cavity, Nasal Floor Width :Width at widest portion of floor of the nose

Secondary Outcomes

  • Maxillary Skeletal Changes(up to 1 year)
  • Dentoalveolar Changes(up to 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmet Yağcı

PROFESSOR

TC Erciyes University

Study Sites (3)

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