Effects of Tongue Tamers as an Early Treatment of Anterior Open Bite

Open Bite Clinical Trial

Official title:

Effects of Tongue Tamers and Customized Bonded Spurs as an Early Treatment of Anterior Open Bite: A Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05792553
• Other study ID #: #R-ORTH-2-23-5
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anterior open bite (AOB) is a malocclusion that causes aesthetic, speech, feeding, and psychological concerns, emphasizing the significance of beginning treatment as soon as possible to correct the disorder. The main etiological determinants of AOB include finger-sucking, pacifiers, and oral habits; hence, it is vital to use interceptive treatments focused on correcting and increasing bite stability during childhood to avoid the need for advanced therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 25, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

Inclusion Criteria:

• male or female patients in early mixed dentition period with age range 7-9 years

• dental anterior open bite equal to or greater than 1 mm,

• class I malocclusion

• clinical signs of anterior tongue thrusting.

Exclusion Criteria:

• Patients with skeletal open bite

• posterior crossbite

• tooth agenesis or loss of permanent teeth

• crowding,

• systemic diseases

Related Conditions & MeSH terms

• Open Bite

Intervention

Device:
• bonded tongue tamers
Enamel surface will be treated initially with 37% phosphoric acid for 30 seconds then tongue tamers will be bonded to the palatal/lingual surface of upper and lower central incisors
• customized bonded spurs
Composite restoration will be used to fabricate the customized bonded spurs with sharp ends and 3 mm in length.
• conventional fixed palatal spurs
conventional fixed palatal spurs will be fabricated by taking impression after band selection, then the spurs appliance will be fabricated from 0.9 mm stainless steel wire and soldered to the bands bilaterally.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the anterior open bite	Measuring method: Digital caliper Measuring unit: Binary (+/-)	3 months
Secondary	cephalometric variables	cephalometric variables including SNA°, SNB°, ANB°, FMA°, U1/FHP°, L1/GoGn°, and overjet will be analyzed pre- and post- treatment.	3 months