3D PrintingNCT07895121
3D-Printed Versus Conventional Palatal Cribs in Managing Tongue Thrusting Habit in Children
A study testing 3D-Printed Palatal Crib Appliance Therapy (Group I): and Conventional Soldered Palatal Crib Appliance Therapy (Group II) in people with 3D Printing and Oral Habit, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial evaluates and compares the clinical effectiveness of 3D-printed palatal cribs versus conventional soldered palatal cribs in managing the tongue thrusting habit in pediatric patients. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- 3D Printing, Oral Habit, Patient Comfort
- What is being tested?
- 3D-Printed Palatal Crib Appliance Therapy (Group I): and Conventional Soldered Palatal Crib Appliance Therapy (Group II)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children presented with tongue thrusting habit.
- Angle class I molar relationship.
- Erupted permanent maxillary \& mandibular central incisors.
- Patients and their parents who demonstrate good cooperation and
Who cannot join
- Children with craniofacial anomalies (e.g., cleft lip and/or palate, craniosynostosis, or syndromic conditions affecting craniofacial growth), any developmental or systemic disorders.
- Skeletal open bite.
- Posterior crossbite.
- Severe or moderate crowding.
- Missing permanent teeth.
- Poor oral hygiene or uncooperative behavior.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Esraa Jamal Ahmed Elbermawy, master contact
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Tanta university
Tanta
shaimaa eldesouky, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
About this study
Official title: 3D-Printed Versus Conventional Palatal Cribs in Managing Tongue Thrusting Habit: A Randomized Clinical Trial
This randomized controlled clinical trial evaluates and compares the clinical effectiveness of 3D-printed palatal cribs versus conventional soldered palatal cribs in managing the tongue thrusting habit in pediatric patients.
Read the detailed description
Thirty children aged 7 to 10 years presenting with a tongue thrusting habit and Class I molar relationship are randomly allocated into two equal groups (n=15 per group). Group I is treated with a 3D-printed selective laser-melted cobalt-chromium palatal crib, while Group II receives a conventional soldered stainless steel palatal crib. Treatment outcomes are evaluated over a 6-month follow-up period by assessing dentoalveolar dimensional changes (via 3D digital model analysis of overjet, overbite, intercanine width, intermolar width, and arch length), appliance survival and structural integrity (debonding, deformation, solder breakage, and loosening), gingival and plaque health indices, and patient-reported comfort and acceptance.
- Conditions
- 3D Printing, Oral Habit, Patient Comfort
- Being tested
- 3D-Printed Palatal Crib Appliance Therapy (Group I):, Conventional Soldered Palatal Crib Appliance Therapy (Group II)
- Keywords
- 3D Printing, Palatal Cribs, Tongue Thrusting Habit, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Palatal Crib Appliance Therapy (Group I):Device
Digital Workflow: Intraoral digital scan captured and saved in STL format; appliance digitally designed using OnyxCeph software.
Fabrication: Manufactured via selective laser melting (SLM) using Remanium® star cobalt-chromium powder.
Cementation: Professional prophylaxis, enamel conditioning with 37% phosphoric acid, application of metal primer to the fitting surface, universal adhesive application, and luting directly to the maxillary first permanent molars using light-cure orthodontic composite resin.
Conventional Soldered Palatal Crib Appliance Therapy (Group II)Device
Impression \& Fabrication: Stainless steel orthodontic bands fitted to maxillary first permanent molars; conventional alginate impression taken; appliance fabricated in a dental laboratory by soldering 0.9 mm stainless steel wire and an anterior crib component to the molar bands.
Cementation: Orthodontic separators placed prior to delivery; appliance cemented using self-curing glass ionomer luting cement (Micron Luting) following standard cleaning and isolation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (3D-Printed Palatal Crib) | Experimental | Children diagnosed with a tongue thrusting habit are treated using a custom-designed 3D-printed palatal crib fabricated via selective laser melting (SLM) of cobalt-chromium alloy from digital intraoral scans. Receives: Device: 3D-Printed Palatal Crib Appliance Therapy (Group I): |
| Control Group (Conventional Palatal Crib) | Active comparator | Children diagnosed with a tongue thrusting habit are treated using a conventional orthodontic palatal crib fabricated with stainless steel bands, soldered wires, and traditional alginate impression methods. Receives: Device: Conventional Soldered Palatal Crib Appliance Therapy (Group II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentoalveolar Dimensional Changes (Dental Cast Analysis)
Measure: Changes in dental arch dimensions measured from digital models (STL files) generated from initial scans (T1) and 6-month post-treatment scans (T2) using 3D analysis software.
Parameters measured include:
Overjet , Overbite , Intercanine width, Intermolar width, Arch length
Measured: Baseline (T1) and 6 months post-cementation (T2).
Secondary outcomes (5)
Appliance Cumulative Survival
Proportion of appliances remaining fully intact and functional without major failure events, expressed as a cumulative percentage.
Measured: At 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Failure Rate
Failure is defined as the occurrence of any of the following binary clinical events (Yes/No):
complete debonding, solder joint breakage, band loosening, or crib dislodgement requiring repair or remaking.
Measured: At 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Gingival Index Score
Evaluation of marginal gingival tissue health surrounding the anchor molars using the Löe-Silness Gingival Index.
Scored on a 0 to 3 scale across four surfaces per tooth (mesial, distal, buccal, lingual):
0 = Normal gingiva, no inflammation;
- = Mild inflammation, slight erythema, no bleeding;
- = Moderate inflammation, erythema, bleeding on probing;
- = Severe inflammation, severe erythema/edema, tendency to spontaneous bleeding. Scores across the four surfaces are averaged.
Measured: Baseline (pre-cementation), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Patient Comfort and Acceptance
Measure: Evaluation of patient-reported perceptions regarding speech interference, eating difficulty, pain/discomfort, and overall satisfaction using a structured questionnaire.
Measured: Assessed during initial adaptation and follow-up intervals over the 6-month study period.
Plaque Index Score
Evaluation of soft deposit accumulation along the gingival margin of anchor teeth using the Silness-Löe Plaque Index.
Scored on a 0 to 3 scale across four surfaces per tooth (mesial, distal, buccal, lingual):
0 = No plaque;
- = Thin film at free gingival margin visible only on probing;
- = Moderate accumulation of soft deposits visible to naked eye;
- = Abundance of soft matter within sulcus/pocket. Scores across the four surfaces are averaged.
Measured: Baseline (pre-cementation), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start5 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 3D PrintingStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895121
- Sponsor's protocol ID
- # PED-1-26-3554
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 29911909Leite JS, Matiussi LB, Salem AC, Provenzano MG, Ramos AL. Effects of palatal crib and bonded spurs in early treatment of anterior open bite: A prospective randomized clinical study. Angle Orthod. 2016 Sep;86(5):734-9. doi: 10.2319/031815-170.1. Epub 2015 Dec 31.
PubMed 26719946
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-Printed Versus Conventional Palatal Cribs in Managing Tongue Thrusting Habit: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07895121
- Acronym / sponsor ID
- # PED-1-26-3554
- Conditions
- 3D Printing, Oral Habit, Patient Comfort
- Keywords
- 3D Printing, Palatal Cribs, Tongue Thrusting Habit, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial evaluates and compares the clinical effectiveness of 3D-printed palatal cribs versus conventional soldered palatal cribs in managing the tongue thrusting habit in pediatric patients.
Detailed description
Thirty children aged 7 to 10 years presenting with a tongue thrusting habit and Class I molar relationship are randomly allocated into two equal groups (n=15 per group). Group I is treated with a 3D-printed selective laser-melted cobalt-chromium palatal crib, while Group II receives a conventional soldered stainless steel palatal crib. Treatment outcomes are evaluated over a 6-month follow-up period by assessing dentoalveolar dimensional changes (via 3D digital model analysis of overjet, overbite, intercanine width, intermolar width, and arch length), appliance survival and structural integrity (debonding, deformation, solder breakage, and loosening), gingival and plaque health indices, and patient-reported comfort and acceptance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (3D-Printed Palatal Crib) | Experimental | Device: 3D-Printed Palatal Crib Appliance Therapy (Group I):Children diagnosed with a tongue thrusting habit are treated using a custom-designed 3D-printed palatal crib fabricated via selective laser melting (SLM) of cobalt-chromium alloy from digital intraoral scans. |
| Control Group (Conventional Palatal Crib) | Active comparator | Device: Conventional Soldered Palatal Crib Appliance Therapy (Group II)Children diagnosed with a tongue thrusting habit are treated using a conventional orthodontic palatal crib fabricated with stainless steel bands, soldered wires, and traditional alginate impression methods. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children presented with tongue thrusting habit.
- Angle class I molar relationship.
- Erupted permanent maxillary \& mandibular central incisors.
- Patients and their parents who demonstrate good cooperation and
Key exclusion criteria (6 listed)
- Children with craniofacial anomalies (e.g., cleft lip and/or palate, craniosynostosis, or syndromic conditions affecting craniofacial growth), any developmental or systemic disorders.
- Skeletal open bite.
- Posterior crossbite.
- Severe or moderate crowding.
- Missing permanent teeth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Printed Palatal Crib Appliance Therapy (Group I):Digital Workflow: Intraoral digital scan captured and saved in STL format; appliance digitally designed using OnyxCeph software. Fabrication: Manufactured via selective laser melting (SLM) using Remanium® star cobalt-chromium powder. Cementation: Professional prophylaxis, enamel conditioning with 37% phosphoric acid, application of metal primer to the fitting surface, universal adhesive application, and luting directly to the maxillary first permanent molars using light-cure orthodontic composite resin. | Device | Experimental Group (3D-Printed Palatal Crib) |
| Conventional Soldered Palatal Crib Appliance Therapy (Group II)Impression \& Fabrication: Stainless steel orthodontic bands fitted to maxillary first permanent molars; conventional alginate impression taken; appliance fabricated in a dental laboratory by soldering 0.9 mm stainless steel wire and an anterior crib component to the molar bands. Cementation: Orthodontic separators placed prior to delivery; appliance cemented using self-curing glass ionomer luting cement (Micron Luting) following standard cleaning and isolation. | Device | Control Group (Conventional Palatal Crib) |
Primary outcome
Dentoalveolar Dimensional Changes (Dental Cast Analysis)
Time frame: Baseline (T1) and 6 months post-cementation (T2).
Measure: Changes in dental arch dimensions measured from digital models (STL files) generated from initial scans (T1) and 6-month post-treatment scans (T2) using 3D analysis software. Parameters measured include: Overjet , Overbite , Intercanine width, Intermolar width, Arch length
5 secondary outcomes
Appliance Cumulative Survival
Time frame: At 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Failure Rate
Time frame: At 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Gingival Index Score
Time frame: Baseline (pre-cementation), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Patient Comfort and Acceptance
Time frame: Assessed during initial adaptation and follow-up intervals over the 6-month study period.
Plaque Index Score
Time frame: Baseline (pre-cementation), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 29911909Rossato 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.
- Results publication: PubMed 26719946Leite JS, Matiussi LB, Salem AC, Provenzano MG, Ramos AL. Effects of palatal crib and bonded spurs in early treatment of anterior open bite: A prospective randomized clinical study. Angle Orthod. 2016 Sep;86(5):734-9. doi: 10.2319/031815-170.1. Epub 2015 Dec 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esraa Jamal Ahmed Elbermawy, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Palatal Crib Appliance Therapy (Group I): and Conventional Soldered Palatal Crib Appliance Therapy (Group II) in people with 3D Printing and Oral Habit, run by Tanta 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 4 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: looking for participants now, as of the sponsor's last update on 26 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa eldesouky, assistant professor (01008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentoalveolar Dimensional Changes (Dental Cast Analysis) (time frame: Baseline (T1) and 6 months post-cementation (T2).). 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 NCT07895121, which also lists 2 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 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.