An interventional study of bonded tongue tamers and customized bonded spurs in Tongue Habits and Open Bite, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 7 Years to 9 Years. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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
34 studies on the registry are indexed under Open Bite; 8 are open to participants now.
This study's enrollment of 75 is above the median of 30 across 28 interventional studies indexed under Open Bite.
Browse Open Bite studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
25 cases with anterior open bite will be treated using bonded tongue tamers
Device: bonded tongue tamers
25 cases with anterior open bite will be treated using customized bonded spurs
Device: customized bonded spurs
25 cases with anterior open bite will be treated using conventional fixed palatal spurs
Device: conventional fixed palatal spurs
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
Composite restoration will be used to fabricate the customized bonded spurs with sharp ends and 3 mm in length.
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.
Change of the anterior open bite
Measuring method: Digital caliper Measuring unit: Binary (+/-)
Time frame: 3 months
cephalometric variables
cephalometric variables including SNA°, SNB°, ANB°, FMA°, U1/FHP°, L1/GoGn°, and overjet will be analyzed pre- and post- treatment.
Time frame: 3 months
Ran from Mar 2023 to primary completion in Jun 2023, 3 months.
Of 24 interventional studies with no phase under Open Bite, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 3 months is below that.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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