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Not yet recruiting NCT07509567

Conventional Palatal Crib Versus Bonded Spurs for Anterior Open Bite Treatment

No phase Interventional Anterior Open Bite

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional Palatal Crib, Bonded Spurs.
Who it may be relevant to
Registry conditions: Anterior Open Bite. Basic parameters: 7 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Conventional Palatal Crib Versus Bonded Spurs in the Treatment of Anterior Open Bite: A Randomized Clinical Trial

Overview

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.

Detailed description

Anterior open bite (AOB) is defined as the absence of vertical overlap between the maxillary and mandibular anterior teeth when the posterior teeth are in occlusion. It is often associated with parafunctional habits such as tongue thrusting, which can lead to dentoalveolar imbalance and malocclusion during growth. Early intervention is essential to prevent functional, esthetic, and psychosocial complications.

Various treatment modalities have been proposed to correct anterior open bite associated with tongue thrusting, including palatal cribs, tongue spurs, functional appliances, and myofunctional therapy. Conventional palatal crib (CPC) appliances act as a mechanical barrier that prevents the tongue from exerting pressure on the anterior teeth, while bonded spurs (BS) provide continuous sensory feedback that discourages improper tongue posture.

This study is designed as a randomized clinical trial with a 1:1 allocation ratio. A total of 20 patients aged 7 to 12 years with dental anterior open bite (≥1 mm), Class I skeletal and dental relationships, and tongue thrusting habit will be recruited. Participants will be randomly assigned to either the CPC group or the BS group.

In the CPC group, bands will be fitted on the maxillary first permanent molars, and a conventional palatal crib constructed from 0.9 mm stainless steel wire will be soldered to the bands. The crib will be positioned posterior to the maxillary incisors to prevent anterior tongue thrust. In the BS group, prefabricated bonded spurs will be placed on the palatal surfaces of the maxillary incisors.

All participants will undergo intraoral scanning before treatment and after 6 months. Outcome measures will include overbite, overjet, and anterior open bite symmetry. Cephalometric analysis will be performed to evaluate skeletal and dental changes, including Sella-Nasion-A point (SNA), Sella-Nasion-B point (SNB),and A point-Nasion-B point (ANB), mandibular plane angle, and incisor inclinations. Vertical dentoalveolar measurements: Upper anterior dental height (UADH), upper posterior dental height (UPDH), lower anterior dental height (LADH), and lower posterior dental height (LPDH) will also be assessed.

Patient-reported outcomes will be evaluated using the Child Perceptions Questionnaire (CPQ8-10), which assesses oral symptoms, functional limitations, emotional well-being, and social well-being. Scores will be recorded at baseline and after treatment.

Data will be statistically analyzed to compare pre- and post-treatment changes within and between groups. The findings of this study are expected to provide clinical evidence regarding the effectiveness and patient acceptance of conventional palatal crib and bonded spurs in the management of anterior open bite.

Interventions

  • Device Conventional Palatal Crib
    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.
  • Device Bonded Spurs
    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.

Primary outcome measures

  • Change in Anterior Open Bite (AOB) [Time frame: 6 months]
Secondary outcome measures (1)
  • Overbite and Overjet Changes [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 29267672
  • 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.
  • 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 33976494
  • 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 29911909
  • 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 36629627
  • 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 39819458
  • 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 16721469
  • 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 37461777

Identifiers

NCT: NCT07509567 · MS.26.01.112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗