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Completed

NCT Number: NCT05930054

Dentoskeletal Changes In The Transverse Dimension Using Tooth Bone-Borne Vs. Bone-Borne Expansion Appliances

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.

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Key information

Conditions

Transverse Maxillary Deficiency

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry ,Department of Orthodontics, Kayseri, Kayseri̇, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

skeletal anchorage and rapid palatal expansion

Device

Eighteen patients were randomly divided into 2 groups through a free randomization program (Random Allocation Software 2.0). Baseline demographic characteristics were matched in both groups. All appliances were fabricated by the same technician in the orthodontic lab. All individuals were treated by a single practitioner.

Primary outcomes

  1. 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

  1. Maxillary Skeletal Changes

    Time frame: up to 1 year

    Maxillary width:Maxillary width tangent to nasal base at tooth level ,palatinal maxillary width:The distance between the inner cortical points of the palatinal bone

  2. Dentoalveolar Changes

    Time frame: up to 1 year

    The palatal alveolar angle (PAA) is the angle between the lines created by drawing tangents to the right and left palatal alveolar plates

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 5, 2023
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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