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

NCT07856277 | Not Yet Recruiting DMC

• 1 other identifier: 3D palatal crib vs. old one
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Digitally Fabricated 3D Printed Palatal Crib

Outcome Measures

Primary Outcomes (1)

• Success rate (habit stop) & patient satisfaction

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

  1 year

Secondary Outcomes (1)

• Durability of the device and the bonding

  1 year

Study Arms (2)

3D printed palatal crib

EXPERIMENTAL

Device: Digitally fabricated 3D printed palatal crib

Conventional palatal crib

ACTIVE COMPARATOR

Device: Digitally fabricated 3D printed palatal crib

Interventions

Digitally fabricated 3D printed palatal crib DEVICE

A newly digitally fabricated palatal crib 3D printed

3D printed palatal crib; Conventional palatal crib

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (10)

• Eltager T, Bardissy AE, Abdelgawad F. Cessation of thumb/finger sucking habit in children using electronic habit reminder versus palatal crib: a randomized clinical pilot study. BMC Oral Health. 2025 Jan 6;25(1):27. doi: 10.1186/s12903-024-05310-6.

  PMID: 39762827 RESULT

• Borrie FR, Bearn DR, Innes NP, Iheozor-Ejiofor Z. Interventions for the cessation of non-nutritive sucking habits in children. Cochrane Database Syst Rev. 2015 Mar 31;2015(3):CD008694. doi: 10.1002/14651858.CD008694.pub2.

  PMID: 25825863 RESULT

• Silva M, Manton D. Oral habits--part 1: the dental effects and management of nutritive and non-nutritive sucking. J Dent Child (Chic). 2014 Sep-Dec;81(3):133-9.

  PMID: 25514257 RESULT

• Shams RH, Ali MM, Kabel N, El Khadem AH. Comparing skeletal and dentoalveolar effects of fixed palatal crib and bonded spurs in early management of anterior open bite associated with non-nutritive sucking habits: a randomized clinical trial. Eur Arch Paediatr Dent. 2026 Apr;27(2):439-451. doi: 10.1007/s40368-025-01086-7. Epub 2025 Aug 1.

  PMID: 40750942 RESULT

• Cousley RRJ. In-house three-dimensional printing within the digital orthodontic workflow. J World Fed Orthod. 2022 Dec;11(6):182-189. doi: 10.1016/j.ejwf.2022.10.001. Epub 2022 Nov 5.

  PMID: 36347751 RESULT

• van der Meer WJ, Vissink A, Ren Y. Full 3-dimensional digital workflow for multicomponent dental appliances: A proof of concept. J Am Dent Assoc. 2016 Apr;147(4):288-91. doi: 10.1016/j.adaj.2015.11.018. Epub 2016 Feb 5.

  PMID: 26857039 RESULT

• Yu X, Li J, Yu L, Wang Y, Gong Z, Pan J. A fully digital workflow for the design and manufacture of a class of metal orthodontic appliances. Heliyon. 2024 May 29;10(11):e32064. doi: 10.1016/j.heliyon.2024.e32064. eCollection 2024 Jun 15.

  PMID: 38867998 RESULT

• Cunha TMAD, Barbosa IDS, Palma KK. Orthodontic digital workflow: devices and clinical applications. Dental Press J Orthod. 2021 Dec 15;26(6):e21spe6. doi: 10.1590/2177-6709.26.6.e21spe6. eCollection 2021.

  PMID: 34932716 RESULT

• Panayi NC. In-house three-dimensional designing and printing customized brackets. J World Fed Orthod. 2022 Dec;11(6):190-196. doi: 10.1016/j.ejwf.2022.10.004. Epub 2022 Nov 5.

  PMID: 36347750 RESULT

• Graf S, Vasudavan S, Wilmes B. CAD-CAM design and 3-dimensional printing of mini-implant retained orthodontic appliances. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):877-882. doi: 10.1016/j.ajodo.2018.07.013.

  PMID: 30477785 RESULT

Study Officials

• Adel El Bardissy, PHD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Nourhhan Hamdy, Bachelor degree

CONTACT

01151201341; nourhan.hussien@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share