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

November 4, 2023 updated by: Safa Basiouny Alawy, Tanta University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 6624033
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 25, 2023

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 4, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #R-ORTH-2-23-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Bite

Clinical Trials on bonded tongue tamers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe