Back to resultsEffects of Tongue Tamers as an Early Treatment of Anterior Open Bite
Primary Purpose
Tongue Habits, Open Bite
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bonded tongue tamers
customized bonded spurs
conventional fixed palatal spurs
Sponsored by
About this trial
This is an interventional treatment trial for Tongue Habits focused on measuring open bite, tongue thrust, habit breaking appliance
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
group I: bonded tongue tamers
group II: customized bonded spurs
group III: conventional fixed palatal spurs
Arm Description
10 cases with anterior open bite will be treated using bonded tongue tamers
10 cases with anterior open bite will be treated using customized bonded spurs
10 cases with anterior open bite will be treated using conventional fixed palatal spurs
Outcomes
Primary Outcome Measures
improvement of the anterior open bite
Overbite will be measured as the primary outcome from the models on each individual anterior tooth
Secondary Outcome Measures
cephalometric variables
cephalometric variables including SNA°, SNB°, ANB°, FMA°, U1/FHP°, L1/GoGn°, and overjet will be analyzed pre- and post- treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05792553
Brief Title
Effects of Tongue Tamers as an Early Treatment of Anterior Open Bite
Official Title
Effects of Tongue Tamers and Customized Bonded Spurs as an Early Treatment of Anterior Open Bite: A Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue Habits, Open Bite
Keywords
open bite, tongue thrust, habit breaking appliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group I: bonded tongue tamers
Arm Type
Experimental
Arm Description
10 cases with anterior open bite will be treated using bonded tongue tamers
Arm Title
group II: customized bonded spurs
Arm Type
Experimental
Arm Description
10 cases with anterior open bite will be treated using customized bonded spurs
Arm Title
group III: conventional fixed palatal spurs
Arm Type
Active Comparator
Arm Description
10 cases with anterior open bite will be treated using conventional fixed palatal spurs
Intervention Type
Device
Intervention Name(s)
bonded tongue tamers
Intervention Description
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
Intervention Name(s)
customized bonded spurs
Intervention Description
Composite restoration will be used to fabricate the customized bonded spurs with sharp ends and 3 mm in length.
Intervention Type
Device
Intervention Name(s)
conventional fixed palatal spurs
Intervention Description
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 Outcome Measure Information:
Title
improvement of the anterior open bite
Description
Overbite will be measured as the primary outcome from the models on each individual anterior tooth
Time Frame
3 months
Secondary Outcome Measure Information:
Title
cephalometric variables
Description
cephalometric variables including SNA°, SNB°, ANB°, FMA°, U1/FHP°, L1/GoGn°, and overjet will be analyzed pre- and post- treatment.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Safa Alawy, PhD
Phone
0201009088252
Email
safa_basyouny@dent.tanta.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Effects of Tongue Tamers as an Early Treatment of Anterior Open Bite
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