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

NCT05930054 | Completed

• 1 other identifier: TDH-2020-10444
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

Transverse Maxillary Deficiency

Keywords

Maxillary expansion; CBCT; tooth-bone-borne; bone-borne

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maxillary Skeletal Changes

  up to 1 year

• Dentoalveolar Changes

  up to 1 year

Study Arms (2)

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.

Device: skeletal anchorage and rapid palatal expansion

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

Device: skeletal anchorage and rapid palatal expansion

Interventions

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.

bone-borne (BB) group; tooth-bone-borne (TBB) group

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (3)

Erciyes University Faculty of Dentistry ,Department of Orthodontics

Kayseri, Kayseri̇, 38000, Turkey (Türkiye)

Location

Erciyes University Faculty of Dentistry ,Department of Orthodontics

Kayseri, Kayseri̇, 38039, Turkey (Türkiye)

Location

Erciyes University Faculty of Dentistry, Department of Orthodontics

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 15782523 BACKGROUND

• 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.

  PMID: 27131254 BACKGROUND

• 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.

  PMID: 20685540 BACKGROUND

Study Officials

• Ahmet YAGCI, PROFESSOR

  Erciyes University faculty of dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: 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 Record Dates

• First Submitted: June 12, 2023
• First Posted: July 5, 2023
• Study Start: September 12, 2020
• Primary Completion: May 10, 2021
• Study Completion: July 12, 2022
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)