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

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

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.

Study Overview

• Status: Completed
• Conditions: Transverse Maxillary Deficiency
• Intervention / Treatment: Device: skeletal anchorage and rapid palatal expansion

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Erciyes University Faculty of Dentistry, Department of Orthodontics
  • Kayseri̇
    • Kayseri, Kayseri̇, Turkey, 38000
      • Erciyes University Faculty of Dentistry ,Department of Orthodontics
    • Kayseri, Kayseri̇, Turkey, 38039
      • Erciyes University Faculty of Dentistry ,Department of Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: tooth-bone-borne (TBB) group; 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.	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.
Other: bone-borne (BB) group; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Director: Ahmet YAGCI, PROFESSOR, Erciyes University Faculty of Dentistry

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2020
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: CBCT; bone-borne; Maxillary expansion; tooth-bone-borne
• Other Study ID Numbers: TDH-2020-10444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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