Evaluation Of Different Rapid Orthodontic Expansion Devices

Cross Bite Clinical Trial

Official title:

Comparison of The Short Term Effects of Different Palatal Expanders Using CBCT.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258411
• Other study ID #: BBRPE
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2015
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2020
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth.

Hypothesis:

H0: There is no difference in the short term effects between the different palatal expanders.

H1: There is a significant difference in the short term effects between the different palatal expanders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 1, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

Inclusion Criteria:

• Non-syndromic adolescent patients.

• Patients in need for palatal expansion treatment.

• Average face height.

• No previous orthodontic treatment.

Exclusion Criteria:

• Syndromic adolescent patients.

• Patients not in need for palatal expansion treatment.

• Non-average face height.

• Previous orthodontic treatment.

Related Conditions & MeSH terms

• Cross Bite
• Malocclusion

Intervention

Device:
• Rapid Expansion of palatal suture

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University, Faculty of Dentistry	Jeddah	Makkah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (2)

Lagravère MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016. — View Citation

Mosleh MI, Kaddah MA, Abd ElSayed FA, ElSayed HS. Comparison of transverse changes during maxillary expansion with 4-point bone-borne and tooth-borne maxillary expanders. Am J Orthod Dentofacial Orthop. 2015 Oct;148(4):599-607. doi: 10.1016/j.ajodo.2015.04.040. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of skeletal and dental expansion	These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.	3 months
Primary	Amount of dental inclination	These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.	3 months