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

Study Overview
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Brief Summary
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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

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

Conditions
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Tongue Habits, Open Bite

Intervention / Treatment
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* Device: bonded tongue tamers
* Device: customized bonded spurs
* Device: conventional fixed palatal spurs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group I: bonded tongue tamers<br>25 cases with anterior open bite will be treated using bonded tongue tamers | Device: bonded tongue tamers<br>* 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<br>|
| Experimental: group II: customized bonded spurs<br>25 cases with anterior open bite will be treated using customized bonded spurs | Device: customized bonded spurs<br>* Composite restoration will be used to fabricate the customized bonded spurs with sharp ends and 3 mm in length.<br>|
| Active Comparator: group III: conventional fixed palatal spurs<br>25 cases with anterior open bite will be treated using conventional fixed palatal spurs | Device: conventional fixed palatal spurs<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the anterior open bite | Measuring method: Digital caliper Measuring unit: Binary (+/-) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cephalometric variables | cephalometric variables including SNA°, SNB°, ANB°, FMA°, U1/FHP°, L1/GoGn°, and overjet will be analyzed pre- and post- treatment. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open bite, tongue thrust, habit breaking appliance