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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05930054
Other study ID # TDH-2020-10444
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2020
Est. completion date July 12, 2022

Study information

Verified date June 2023
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date July 12, 2022
Est. primary completion date May 10, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
skeletal anchorage and rapid palatal expansion
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.

Locations

Country Name City State
Turkey Erciyes University Faculty of Dentistry ,Department of Orthodontics Kayseri Kayseri?
Turkey Erciyes University Faculty of Dentistry ,Department of Orthodontics Kayseri Kayseri?
Turkey Erciyes University Faculty of Dentistry, Department of Orthodontics Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Carlson C, Sung J, McComb RW, Machado AW, Moon W. Microimplant-assisted rapid palatal expansion appliance to orthopedically correct transverse maxillary deficiency in an adult. Am J Orthod Dentofacial Orthop. 2016 May;149(5):716-28. doi: 10.1016/j.ajodo.2015.04.043. — View Citation

Lagravere MO, Major PW, Flores-Mir C. Skeletal and dental changes with fixed slow maxillary expansion treatment: a systematic review. J Am Dent Assoc. 2005 Feb;136(2):194-9. doi: 10.14219/jada.archive.2005.0141. — View Citation

Lee KJ, Park YC, Park JY, Hwang WS. Miniscrew-assisted nonsurgical palatal expansion before orthognathic surgery for a patient with severe mandibular prognathism. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):830-9. doi: 10.1016/j.ajodo.2007.10.065. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Nasal Changes 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 up to 1 year
Secondary Maxillary Skeletal Changes 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 up to 1 year
Secondary Dentoalveolar Changes The palatal alveolar angle (PAA) is the angle between the lines created by drawing tangents to the right and left palatal alveolar plates up to 1 year
See also
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Completed NCT03503448 - Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion N/A
Active, not recruiting NCT06130748 - Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood N/A
Withdrawn NCT05295771 - Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion. N/A