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

NCT ID: NCT05792553

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-07-25

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

Detailed Description

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Conditions

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Tongue Habits Open Bite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group I: bonded tongue tamers

25 cases with anterior open bite will be treated using bonded tongue tamers

Group Type EXPERIMENTAL

bonded tongue tamers

Intervention Type 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

group II: customized bonded spurs

25 cases with anterior open bite will be treated using customized bonded spurs

Group Type EXPERIMENTAL

customized bonded spurs

Intervention Type DEVICE

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

group III: conventional fixed palatal spurs

25 cases with anterior open bite will be treated using conventional fixed palatal spurs

Group Type ACTIVE_COMPARATOR

conventional fixed palatal spurs

Intervention Type 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.

Interventions

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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

Intervention Type DEVICE

customized bonded spurs

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Safa Basiouny Alawy

Lecturer of Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, , Egypt

Site Status

Countries

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Egypt

References

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Alawy SB, El-Desouky SS, Kabbash IA, Hadwa SM. Effects of tongue tamers and customized bonded spurs as an early treatment of anterior open bite: a randomized clinical study. BMC Oral Health. 2025 Jan 16;25(1):76. doi: 10.1186/s12903-024-05389-x.

Reference Type DERIVED
PMID: 39819458 (View on PubMed)

Other Identifiers

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#R-ORTH-2-23-5

Identifier Type: -

Identifier Source: org_study_id

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