Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate

NARecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

May 1, 2022

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2026

Conditions
Cleft Lip and PalateUnilateral Cleft Lip
Interventions
PROCEDURE

passive Alveolar Molding

A passive palate plate (passive Alveolar Molding) will be inserted within the first week after birth. The pAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and the treatment with the pAM appliance will continue until palate closure (10-12 months of life).

PROCEDURE

Nasoalveolar Molding

A passive palate plate will be inserted within the first week after birth. A nasal stent will be added to the palate plate after one week (NAM appliance). The NAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and will be treated with a passive palate plate without nasal stent until palate closure (10-12 months of life).

Trial Locations (1)

91054

RECRUITING

Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg, Erlangen

All Listed Sponsors
lead

University of Erlangen-Nürnberg

OTHER