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OpenTrials
Completed

NCT Number: NCT05792553

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

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

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Key information

Conditions

Tongue Habits Behavior Habits Malocclusion Open Bite Stomatognathic Diseases Tooth Diseases

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, 6624033, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bonded tongue tamers

Device

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

Device

Composite restoration will be used to fabricate the customized bonded spurs with sharp ends and 3 mm in length.

conventional fixed palatal spurs

Device

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.

Primary outcomes

  1. Change of the anterior open bite

    Time frame: 3 months

    Measuring method: Digital caliper Measuring unit: Binary (+/-)

Secondary outcomes

  1. cephalometric variables

    Time frame: 3 months

    cephalometric variables including SNA°, SNB°, ANB°, FMA°, U1/FHP°, L1/GoGn°, and overjet will be analyzed pre- and post- treatment.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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