Evaluation of the Jaw Index for the determination of micrognathia and visualization of the facial profile using 3D photography in healthy newborns and infants with Pierre Robin sequence and their first-degree relatives

• Conditions: MedDRA - 10035009; Q87.0; Congenital malformation syndromes predominantly affecting facial appearance

• Registration Number: DRKS00017769
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-18
• Study Completion: 2020-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

RS Infants:
Infants with RS (based on the clinical diagnostic criteria: retrognathia, glossoptosis and obstructive breathing)

Control group:
Full-term newborns > 37 0/7 weeks of gestational age
1st degree relatives for photos (parents): parents, first degree siblings of both study groups

Exclusion Criteria

Childhood malformations or chromosomal abnormalities in the healthy control group

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Jaw Index differs significantly between healthy newborns and infants with Pierre Robin sequence.

Secondary Outcome Measures

Name	Time	Method
1. the Jaw Index is well reproducible and shows no relevant difference between repeat measurements of one examiner or between two different examiners<br>2. the measured values of alveolar overbite differ depending on the waking state or muscle tone (e.g. during sleep or awake).<br>3. the lower jaw of children with RS shows a catch-up growth after spur plate treatment, thus the Jaw-Index decreases in the course of plate therapy.<br>4. the facial profile in the 3D image in healthy children differs significantly from that in children with RS.<br>5. The facial profile in the 3D image of children with RS is changed after Tuebingen plate treatment, the lower jaw shows catch-up growth and the degree of retrognathy decreases in the course of therapy.<br>6. The orthodontic history and clinical measurement of jaw dimensions using Jaw Index and 2D/3D photography in adult parents of a PRS child differ from those of the healthy control group.