The impact of cleft lip and palate (CLP) on the oral microbiome, the local immune response and clinical parameters during interdisciplinary orthodontic treatments

The impact of cleft lip and palate (CLP) on the oral microbiome, the local immune response and clinical parameters during interdisciplinary orthodontic treatments - CleftBiome

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033429

Enrollment

974

Registered

2024-01-22

Start date

2024-07-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q35-Q37

Interventions

Group 1: I) Newborns/infants/toddlers with and without CLP In newborns/infants with CLP, 2 swabs are taken from the tongue, one of which is used to analyze the oral microbiome and one to analyze cytok

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Newborns with cleft lip and palate and their mothers - Newborns without cleft lip and palate malformation and their mothers - Children and adolescents with cleft lip and palate - Children and adolescents without cleft lip and palate malformation

Exclusion criteria

Exclusion criteria: Withdrawal of the declaration of consent by the parents/legal guardians

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the difference between the study group (patients with cleft lip and palate) and the control group (patients without cleft malformation) regarding the oral microbiome (alpha diversity) per study time point. Sample collection from different oral niches (tongue, cleft margin, gingival crevicular fluid) and investigation of the oral microbiome using 16SrRNA sequenzierung.	—

Secondary

Measure	Time frame
1) Local immune response Difference between the study group (patients with cleft lip and palate) and the control group (patients without cleft malformation) regarding the local cytokine concentrations per study time point. Sample collection from different oral niches (tongue, cleft margin, gingival crevicular fluid) and investigation of the local cytokine concentrations using Luminex-Immunoassay (TNF-a, INF-?, IL-2/-4/-6/-10/-17/-1ß, GM-CSF, OPG, RANKL). 2) Oral health Difference between the study group (patients with cleft lip and palate) and the control group (patients without cleft malformation) regarding oral health per study time point. Elevation of dental status, loosening of teeth, plaque index, gingival index, periodontal screening index. Clinical evaluation of pre- ans post-operative parameters (wound healing disorders) and taking of intraoral pictures. 3) Maxillary growth during presurgical infant orthodontic cleft treatment Evaluation of the maxillary growth (cleft width, transversal width and sagittal length of the maxillary alveolar segments, rotation of cleft segments) using maxillary impressions and digital 3-dimesional scans. Setting of anatomical points 3-dimensionally, measuremtns of distances and angles. 4) Tooth movement during orthodontic treatment Difference between the study group (patients with cleft lip and palate) and the control group (patients without cleft malformation) regarding tooth movement during orthodontic treatment. Taking of 3-dimensional intraoral scans. Superposition of the scan using surface-related matching, e.g., with anatomical points (Rugae palatinae), using an iterative closest point (ICP) algorithm. Segmentation of teeth and calculation of tooth movement in each spatial direction.	—

Measure

Time frame

1) Local immune response Difference between the study group (patients with cleft lip and palate) and the control group (patients without cleft malformation) regarding the local cytokine concentrations per study time point. Sample collection from different oral niches (tongue, cleft margin, gingival crevicular fluid) and investigation of the local cytokine concentrations using Luminex-Immunoassay (TNF-a, INF-?, IL-2/-4/-6/-10/-17/-1ß, GM-CSF, OPG, RANKL). 2) Oral health Difference between the study group (patients with cleft lip and palate) and the control group (patients without cleft malformation) regarding oral health per study time point. Elevation of dental status, loosening of teeth, plaque index, gingival index, periodontal screening index. Clinical evaluation of pre- ans post-operative parameters (wound healing disorders) and taking of intraoral pictures. 3) Maxillary growth during presurgical infant orthodontic cleft treatment Evaluation of the maxillary growth (cleft width, transversal width and sagittal length of the maxillary alveolar segments, rotation of cleft segments) using maxillary impressions and digital 3-dimesional scans. Setting of anatomical points 3-dimensionally, measuremtns of distances and angles. 4) Tooth movement during orthodontic treatment Difference between the study group (patients with cleft lip and palate) and the control group (patients without cleft malformation) regarding tooth movement during orthodontic treatment. Taking of 3-dimensional intraoral scans. Superposition of the scan using surface-related matching, e.g., with anatomical points (Rugae palatinae), using an iterative closest point (ICP) algorithm. Segmentation of teeth and calculation of tooth movement in each spatial direction.

—

Countries

Germany

Contacts

Public ContactCorinna Seidel

Poliklink für Kieferorthopädie, Ludwig-Maximilians-Universität München

corinna.seidel@med.uni-muenchen.de089 4400 53233

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026