UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061921 |
|---|---|
| Receipt number | R000070846 |
| Scientific Title | Exploratory prospective interventional study evaluating the effects of probiotic administration on oral microbiota and bone graft survival after alveolar bone grafting |
| Date of disclosure of the study information | 2026/06/16 |
| Last modified on | 2026/06/15 22:24:43 |
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Basic information
Public title
Exploratory prospective interventional study evaluating the effects of probiotic administration on oral microbiota and bone graft survival after alveolar bone grafting
Acronym
ProBio-ABG Study
Scientific Title
Exploratory prospective interventional study evaluating the effects of probiotic administration on oral microbiota and bone graft survival after alveolar bone grafting
Scientific Title:Acronym
ProBio-ABG Study
Region
| Japan |
Condition
Condition
Cleft lip and palate
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone graft survival rate assessed by three-dimensional volumetric analysis using CT images obtained 6 months after surgery.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Control group
Interventions/Control_2
Participants in the intervention group will receive Lactobacillus salivarius LS1 orally for one week before surgery.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 12 | 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 sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Kobori |
Organization
National Center for Child Health and Development
Division name
Plastic Surgery
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo
TEL
03-3416-0181
iida-c@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Kobori |
Organization
National Center for Child Health and Development
Division name
Plastic Surgery
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo
TEL
03-3416-0181
Homepage URL
iida-c@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo
Tel
03-3416-0181
rinri@ncchd.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070846
