Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061921) titled 'Exploratory prospective interventional study evaluating the effects of probiotic administration on oral microbiota and bone graft survival after alveolar bone grafting' on June 16.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - National Center for Child Health and Development

Condition: Condition - Cleft lip and palate Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Alveolar bone grafting is a standard treatment for patients with cleft lip and palate; however, considerable variability remains in graft survival outcomes. Recent evidence suggests that local microbial environments may influence tissue repair and bone regeneration through modulation of inflammatory and immune responses. This exploratory prospective interventional study aims to evaluate the relationship between oral microbiota and bone graft survival in patients undergoing alveolar bone grafting. In addition, the effects of preoperative probiotic administration (Lactobacillus salivarius LS1) on oral microbiota composition and subsequent bone graft survival will be investigated. The findings of this study may provide a basis for novel perioperative microbial management strategies in oral and maxillofacial surgery. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Control group Interventions/Control_2 - Participants in the intervention group will receive Lactobacillus salivarius LS1 orally for one week before surgery.

Eligibility: Age-lower limit - 6 years-old = Gender - Male and Female Key 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. Key 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. Target Size - 15

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 07 Month 07 Day Date of IRB - 2025 Year 07 Month 14 Day Anticipated trial start date - 2025 Year 07 Month 15 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070846

Disclaimer: Curated by HT Syndication.