Cleft lip and palate
Conditions
Interventions
Control group
Participants in the intervention group will receive Lactobacillus salivarius LS1 orally for one week before surgery.
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Probiotic administration group Inclusion criteria Patients undergoing primary alveolar bone grafting. Age 6-13 years at the time of surgery. Previous surgical history of cleft lip and/or cleft palate repair is not restricted. Patients considered fit for general anesthesia by the attending physician based on their overall health condition. Written informed consent obtained from a legally authorized representative. ii) Control group (non-administration group) Inclusion criteria Patients who underwent alveolar bone grafting between April 2022 and March 2025 and met inclusion criteria 1-4 above, and who did not decline participation through the opt-out procedure.
Exclusion criteria
Exclusion criteria: Probiotic administration group Exclusion criteria Inability to orally ingest the probiotic preparation. Failure to obtain written informed consent from the patient and/or legal guardian. ii) Control group Exclusion criteria Patients who opt out of participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone graft survival rate assessed by three-dimensional volumetric analysis using CT images obtained 6 months after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Characteristics of oral microbiota at the alveolar cleft site, normal dentition, and buccal mucosa. Changes in oral microbiota before and after probiotic administration. Association between oral microbiota composition and bone graft survival. Changes in caries-related and periodontal pathogen-associated bacteria. Adverse events related to probiotic administration. | — |
Countries
Japan
Contacts
Public ContactChie Kobori
National Center for Child Health and Development Plastic Surgery
Outcome results
None listed