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Anterior Open BiteNCT07509567

Conventional Palatal Crib Versus Bonded Spurs for Anterior Open Bite Treatment

A study testing Conventional Palatal Crib and Bonded Spurs in people with Anterior Open Bite, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Anterior Open Bite
What is being tested?
Conventional Palatal Crib and Bonded Spurs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
1 Apr 2026to 1 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry, Mansoura University

    Al Mansurah, Dakahlia Governorate, 35516

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
Conventional Palatal Crib, Bonded Spurs
Keywords
Anterior Open Bite , Palatal Crib , Bonded Spurs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07509567
Study groupRoleWhat they receive
Conventional Palatal Crib (CPC)ExperimentalParticipants 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.
Receives: Device: Conventional Palatal Crib
Bonded Spurs (BS)ExperimentalParticipants 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.
Receives: Device: Bonded Spurs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)
  1. Overbite and Overjet Changes

    Assessment of vertical (overbite) and horizontal (overjet) relationship between upper and lower incisors using intraoral scans.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2026
  2. Study start1 Apr 2026
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07509567
Sponsor's protocol ID
MS.26.01.112
Status last verified
Sep 2026
First submitted
29 Mar 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 37461777
  • 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.

    PubMed 35130348
  • 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.

    PubMed 31056074

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Palatal Crib and Bonded Spurs in people with Anterior Open Bite, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anterior Open Bite (AOB) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07509567, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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