NCT07509567

Brief Summary

This randomized clinical trial aims to compare the effectiveness and patient acceptance of two orthodontic appliances-conventional palatal crib and bonded spurs-in the treatment of anterior open bite in children.Twenty children aged 7 to 12 years with anterior open bite and Class I skeletal and dental relationships will be randomly assigned to one of two groups The first group will receive a conventional palatal crib appliance fixed to the upper molars, while the second group will receive bonded spurs attached to the palatal surfaces of the upper incisors , All participants will be followed for 6 months. Clinical and digital measurements, including overbite ,The results of this study are expected to help determine which appliance provides better clinical outcomes and higher patient acceptance in the early treatment of anterior open bite.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress21%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

March 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

12 days

First QC Date

March 29, 2026

Last Update Submit

July 20, 2026

Conditions

Anterior Open Bite

Keywords

Anterior Open Bite , Palatal Crib , Bonded Spurs

Outcome Measures

Primary Outcomes (1)

  • Change in Anterior Open Bite (AOB)

    Measurement of vertical overlap (in mm) between the upper and lower anterior teeth before and after treatment using intraoral scans.

    6 months

Secondary Outcomes (1)

  • Overbite and Overjet Changes

    6 months

Study Arms (2)

Conventional Palatal Crib (CPC)

EXPERIMENTAL

Participants will receive a conventional palatal crib appliance fixed to the maxillary first molars. The appliance is made of 0.9 mm stainless steel wire with 5-7 loops and an acrylic button covering the base. It is positioned 3-4 mm posterior to the cingula of the maxillary incisors to prevent tongue thrusting. The appliance is cemented with glass ionomer cement and monitored over a 6-month treatment period.

Device: Conventional Palatal Crib

Bonded Spurs (BS)

EXPERIMENTAL

Participants will receive bonded spurs attached to the middle third of the palatal surfaces of the maxillary and mandibular incisors to correct anterior tongue posture and prevent contact with anterior teeth. The spurs act as a reminder to maintain proper tongue positioning. Treatment is monitored over a 6-month period.

Device: Bonded Spurs

Interventions

Bonded SpursDEVICE

Bonded spurs are placed on the middle third of the palatal surfaces of the maxillary and mandibular incisors. They correct anterior open bite by preventing the tongue from contacting the upper and lower anterior teeth and reminding the patient to maintain proper tongue position. Treatment duration is 6 months.

Bonded Spurs (BS)
Conventional Palatal CribDEVICE

A fixed orthodontic appliance made of 0.9 mm stainless steel wire with 5-7 loops and an acrylic button covering the base.It is cemented to the maxillary first molars using Ultra band cement and positioned 3-4 mm posterior to the cingula of maxillary incisors to prevent tongue thrusting. Treatment duration is 6 months.

Conventional Palatal Crib (CPC)

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 7 to 12 years
  • Skeletal Class I relationship
  • Angle Class I dental relationship
  • Dental anterior open bite ≥ 1 mm
  • Open bite limited to the anterior segment (incisors and canines)
  • Presence of tongue thrusting habit with anterior tongue posture
  • Patients in mixed dentition stage
  • Fully erupted upper and lower central incisors
  • Fully erupted maxillary first permanent molars
  • Good oral hygiene
  • No gender restrictions
  • Upper arch with no or mild crowding

You may not qualify if:

  • Mouth breathing
  • Skeletal anterior open bite
  • Presence of posterior crossbite
  • Congenitally missing teeth
  • Dental anomalies
  • Presence of any systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Duarte-Rodrigues L, Ramos-Jorge J, Drumond CL, Diniz PB, Marques LS, Ramos-Jorge ML. Correlation and comparative analysis of the CPQ8-10 and child-OIDP indexes for dental caries and malocclusion. Braz Oral Res. 2017 Dec 18;31:e111. doi: 10.1590/1807-3107bor-2017.vol31.0111.

    PMID: 29267672RESULT

  • 9. Nasser M, Yousry TN, Ismail H. Patient Acceptance and Satisfaction: A Comparative Study of Low Transpalatal Arch with Tongue Spurs versus Tongue Spurs Alone in Developing Anterior Open Bite Treatment. Egyptian Orthodontic Journal. 2025;67(1):157-77.

    RESULT

  • Zhao W, Chen Y, Kyung HM, Xu JS. Effectiveness of Tongue Crib Combination Treating Severe Skeletal Angle Class III Malocclusion in Mixed Dentition. Int J Clin Pediatr Dent. 2020 Nov-Dec;13(6):668-676. doi: 10.5005/jp-journals-10005-1855.

    PMID: 33976494RESULT

  • Rossato PH, Fernandes TMF, Urnau FDA, de Castro AC, Conti F, de Almeida RR, Oltramari-Navarro PVP. Dentoalveolar effects produced by different appliances on early treatment of anterior open bite: A randomized clinical trial. Angle Orthod. 2018 Nov;88(6):684-691. doi: 10.2319/101317-691.1. Epub 2018 Jun 18.

    PMID: 29911909RESULT

  • Kraisiridej R, Suzuki B, Suzuki EY. Dentoalveolar changes observed after the use of customized bonded Shark-Tooth-Like Spurs (JAWs) in adult patients with anterior open bite. Dental Press J Orthod. 2023 Jan 6;27(5):e2220448. doi: 10.1590/2177-6709.27.5.e2220448.oar. eCollection 2023.

    PMID: 36629627RESULT

  • 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: 39819458RESULT

  • Stuani AS, Stuani AS, Stuani MB, Saraiva Mda C, Matsumoto MA. Anterior open bite--cephalometric evaluation of the dental pattern. Braz Dent J. 2006;17(1):68-70. doi: 10.1590/s0103-64402006000100015. Epub 2006 May 2.

    PMID: 16721469RESULT

  • Manzoor Z, Wadhawan A, Nagar S, Kumar A, Singh M. A Modified Tongue Crib Appliance for Correction of Tongue Thrusting. Cureus. 2023 Jun 16;15(6):e40518. doi: 10.7759/cureus.40518. eCollection 2023 Jun.

    PMID: 37461777RESULT

  • Fouda AS, Afify AK, Aboulfotouh MH, Attia KH, Abouelezz AM, Elkordy SA. Dental arch changes after anterior open bite treatment in the mixed dentition produced by miniscrew-supported palatal crib vs conventional fixed palatal crib. Angle Orthod. 2022 Jul 1;92(4):487-496. doi: 10.2319/082321-659.1.

    PMID: 35130348RESULT

  • Dias FA, Assis Urnau FD, Pedron Oltramari PV, Lupion Poleti M, Rodrigues de Almeida M, Freire Fernandes TM. Stability of early treatment of anterior open bite: clinical performance of bonded lingual spurs. J Orthod. 2019 Mar;46(1):68-73. doi: 10.1177/1465312519827601. Epub 2019 Feb 1.

    PMID: 31056074RESULT

Related Links

Study Officials

  • Dr. Ahmed El-Bialy, Professor, Department of Ortho

    Faculty of Dentistry, Mansoura University

    STUDY CHAIR

Central Study Contacts

Hassan Hani Al-fadhli, B.D.Sc

CONTACT

021555422609Hassan_Alfadhli@std.mans.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of participants and care providers is not feasible due to the nature of the interventions. However, outcome assessors and data analysts will be blinded to group allocation to reduce measurement bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into two parallel groups with a 1:1 allocation ratio. One group will receive a conventional palatal crib appliance, while the other group will receive bonded spurs. Both interventions will be applied simultaneously, and outcomes will be compared after a 6-month follow-up period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student, Department of Orthodontics, Faculty of Dentistry

Study Record Dates

First Submitted

March 29, 2026

First Posted

April 3, 2026

Study Start

July 20, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to the limited sample size and the study being conducted as part of a postgraduate thesis. All data will be kept confidential in accordance with institutional ethical guidelines, and no publicly accessible dataset will be generated.