- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509567
Conventional Palatal Crib Versus Bonded Spurs for Anterior Open Bite Treatment
Conventional Palatal Crib Versus Bonded Spurs in the Treatment of Anterior Open Bite: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hassan Hani Al-fadhli, B.D.Sc
- Phone Number: 021555422609
- Email: Hassan_Alfadhli@std.mans.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conventional Palatal Crib (CPC)
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.
|
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.
|
|
Experimental: Bonded Spurs (BS)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anterior Open Bite (AOB)
Time Frame: 6 months
|
Measurement of vertical overlap (in mm) between the upper and lower anterior teeth before and after treatment using intraoral scans.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overbite and Overjet Changes
Time Frame: 6 months
|
Assessment of vertical (overbite) and horizontal (overjet) relationship between upper and lower incisors using intraoral scans.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dr. Ahmed El-Bialy, Professor, Department of Ortho, Faculty of Dentistry, Mansoura University
Publications and helpful links
General 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. Brazilian Oral Research. 2017;31(0).
- 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.
- 8. Zhao W, Chen Y, Kyung H-M, Xu J-S. Effectiveness of Tongue Crib Combination Treating Severe Skeletal Angle Class III Malocclusion in Mixed Dentition. International Journal of Clinical Pediatric Dentistry. 2020;13(6):668-76.
- 7. 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. The Angle Orthodontist. 2018;88(6):684-91.
- 6. 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 Journal of Orthodontics. 2022;27(5).
- 5. 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;25(1).
- 4. Stuani AS, Stuani AS, Stuani MBS, Saraiva MdCP, Matsumoto MAN. Anterior open bite: cephalometric evaluation of the dental pattern. Brazilian Dental Journal. 2006;17(1):68-70.
- 3. Manzoor Z, Wadhawan A, Nagar S, Kumar A, Singh M. A Modified Tongue Crib Appliance for Correction of Tongue Thrusting. Cureus. 2023.
- 1. 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. The Angle Orthodontist. 2022;92(4):487-96.
- 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. Journal of Orthodontics. 2019;46(1):68-73.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MS.26.01.112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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