The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance

Transverse Maxillary Deficiency Clinical Trial

Official title:

The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance: A Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06009796
• Other study ID #: TDH-2022-12101
• Status: Completed
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: August 2023
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effects of dentoalveolar, dentoskeletal, nasal resistance, and airway changes by applying rapid palatal expansion appliances in patients with maxillary constriction and the post-pubertal growth spurt stage.

Description:

Fifty eight patients were divided into 4 groups. The first group (n: 15, 15.6 ± 1,1 years of age) was Full Coverage Rapid Palatal Expansion (FCRPE). The second group ( n:14, 15.3 ± 0,9 years of age) was Modified McNamara Rapid Palatal Expansion (MMRPE). The third group (n:14, 15.7 ± 1,1 years of age) was Miniimplant Assisted Rapid Palatal Expansion (MARPE). The fourth group (n:15, 15.4 ± 1,0 years of age) was control group. Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model, and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 12, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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

• Individuals with a body mass index of 18-24

• Individuals with an ANB angle between 0º and 4º

Exclusion Criteria:

• craniofacial anomalies

• compliance problems

• systemic or genetic disease

• previous orthodontic treatment history

Related Conditions & MeSH terms

• Transverse Maxillary Deficiency

Intervention

Device:
• Tooth Tissue Borne Rapid Palatal Expansion
In all rapid palatal expansion groups, the appliances were cis bonded after being made by the same technician. The expansion screw was turned twice a day until the desired width was achieved.
• Tooth Bone Borne Rapid Palatal Expansion
After the Marpe appliance was attached, 4 miniscrews were applied to the midline of the palate with a miniscrew driver. The expansion screw was turned twice a day until the desired width was achieved.

Locations

Country	Name	City	State
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)

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

Seeberger R, Kater W, Schulte-Geers M, Davids R, Freier K, Thiele O. Changes after surgically-assisted maxillary expansion (SARME) to the dentoalveolar, palatal and nasal structures by using tooth-borne distraction devices. Br J Oral Maxillofac Surg. 2011 Jul;49(5):381-5. doi: 10.1016/j.bjoms.2010.05.015. Epub 2010 Jun 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhinomanometry Measurement Parameters (Pa/cm3/sn )	-Total Nasal Resistance(Pa/cm3/sn ): In our study, total nasal resistance was measured with a rhinomanometry device.	up to 1 year
Primary	Polygraphy Measurement Parameters (event/hour)	- Apnea-Hypopnea Index (event/hour) : In our study, Apnea-Hypopnea Index(AHI) was measured with a polygraphy device. - Oxygen Desaturation index (De SPO2) : In our study, De SPO2 was measured with a polygraphy device.	up to 1 year
Secondary	Postero-anterior Measurement Parameters(mm)	NCB-NCB': Distance between right and left nasal cavity borders(mm); JP-JP' : Distance between right and left jugal processes(mm); AGP-AGP' : Distance between right and left antagonial points(mm)	up to 1 year
Secondary	Model Measurement Parameters(mm)	C-C : Distance between cusp crests of canines(mm); C'-C' : Distance between cingulum of canines(mm); M1-M1 : The distance between buccal tubercles of first molar(mm); M1'-M1' : The distance between the lingual tubercles of first molar(mm)	up to 1 year