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

NCT ID: NCT05930054

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-12

Study Completion Date

2022-07-12

Brief Summary

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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

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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.

Conditions

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Transverse Maxillary Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

skeletal anchorage and rapid palatal expansion

Intervention Type 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

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

Group Type OTHER

skeletal anchorage and rapid palatal expansion

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Yağcı

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmet YAGCI, PROFESSOR

Role: STUDY_DIRECTOR

Erciyes University faculty of dentistry

Locations

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Erciyes University Faculty of Dentistry ,Department of Orthodontics

Kayseri, Kayseri̇, Turkey (Türkiye)

Site Status

Erciyes University Faculty of Dentistry ,Department of Orthodontics

Kayseri, Kayseri̇, Turkey (Türkiye)

Site Status

Erciyes University Faculty of Dentistry, Department of Orthodontics

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 15782523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27131254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20685540 (View on PubMed)

Other Identifiers

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TDH-2020-10444

Identifier Type: -

Identifier Source: org_study_id

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