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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorCairo University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digitally fabricated 3D printed palatal crib

    Device

    A newly digitally fabricated palatal crib 3D printed

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: 3D printed palatal cribExperimental treatment 1 intervention
Group B: Conventional palatal cribActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Success rate (habit stop) & patient satisfaction

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

Time frame
1 year

Secondary outcomes

1

Durability of the device and the bonding

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: