Clinical Evaluation of Digitally Fabricated 3D Printed Palatal Crib Versus Conventional Palatal Crib

September 27, 2026 updated by: Nourhan Hamdy Hussein Abdelfatah Ahmed, Cairo University

Clinical Evaluation of Digitally Fabricated 3D Printed Palatal Crib Versus Conventional Palatal Crib: A Randomized Clinical Trial

The aim of this study is to evaluate clinically digitally fabricated 3d printed palatal crib versus conventional palatal crib

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the clinical performance of a 3D printed palatal crib as an alternative to the conventional palatal crib in managing persistent thumb sucking. The findings may provide evidence on whether digital fabrication offers comparable clinical effectiveness while simplifying the fabrication process and improving appliance customization

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children aged 6-9 years
  • children with persistwnt thumb sucking habit requiring palatal crib therapy
  • healthy children (ASA I & II)
  • cooperative children whise parents/guardians provide written informed consent and who are willing to attend follow up visits

Exclusion Criteria:

  • children with cranifacial anomalies or syndromes ( cleft lip and palate )
  • children currently receiving or with a previous history of orthodontic treatment or habit breaking appliance therapy
  • children with poor oral hygiene, untreated dental caries, or active periodontal disease requiring treatment before appliance placement
  • children with allergies or hypersensitivity to any material used in the appliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D printed palatal crib
Device: Digitally fabricated 3D printed palatal crib

A newly digitally fabricated palatal crib 3D printed
Active Comparator: Conventional palatal crib
Device: Digitally fabricated 3D printed palatal crib

A newly digitally fabricated palatal crib 3D printed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate (habit stop) & patient satisfaction
Time Frame: 1 year

The habit stop during period of time & patient satisfaction using likert facial scale
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Durability of the device and the bonding
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Adel El Bardissy, PHD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 27, 2026

First Submitted That Met QC Criteria

September 27, 2026

First Posted (Actual)

October 2, 2026

Study Record Updates

Last Update Posted (Actual)

October 2, 2026

Last Update Submitted That Met QC Criteria

September 27, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 3D palatal crib vs. old one

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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