NCT05792553

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

March 19, 2023

Last Update Submit

November 4, 2023

Conditions

Tongue HabitsOpen Bite

Keywords

open bitetongue thrusthabit breaking appliance

Outcome Measures

Primary Outcomes (1)

  • Change of the anterior open bite

    Measuring method: Digital caliper Measuring unit: Binary (+/-)

    3 months

Secondary Outcomes (1)

  • cephalometric variables

    3 months

Study Arms (3)

group I: bonded tongue tamers

EXPERIMENTAL

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

Device: bonded tongue tamers

group II: customized bonded spurs

EXPERIMENTAL

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

Device: customized bonded spurs

group III: conventional fixed palatal spurs

ACTIVE COMPARATOR

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

Device: conventional fixed palatal spurs

Interventions

bonded tongue tamersDEVICE

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 I: bonded tongue tamers
customized bonded spursDEVICE

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

group II: customized bonded spurs
conventional fixed palatal spursDEVICE

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.

group III: conventional fixed palatal spurs

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with skeletal open bite
  • posterior crossbite
  • tooth agenesis or loss of permanent teeth
  • crowding,
  • systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, 6624033, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 39819458DERIVED

MeSH Terms

Conditions

Tongue HabitsOpen Bite

Condition Hierarchy (Ancestors)

HabitsBehaviorMalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthodontics

Study Record Dates

First Submitted

March 19, 2023

First Posted

March 31, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 25, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

EG(1)