Surgery--Complications Clinical Trial
Official title:
Effect of Probiotic Intervention With Lactobacillus Brevis KABP052 (CECT7480) and Lactobacillus Plantarum KABP051 (CECT7481) After Surgical Removal of Mandibular Third Molars: a Randomized, Controlled, Double-blinded Trial
NCT number | NCT04203771 |
Other study ID # | PB-0202015-FHNB |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | May 2017 |
Verified date | May 2020 |
Source | AB Biotics, SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single-center, double-blind, randomized trial of probiotics L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) taken twice daily for 7 days after surgical removal of both mandibular 3rd molars. Patients were assessed for surgery-derived complications in a follow-up visit 7 days after surgery, and provided daily evaluations of pain, swelling and eating difficulty in a patient diary.
Status | Completed |
Enrollment | 38 |
Est. completion date | May 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 25 Years |
Eligibility |
Inclusion Criteria: - Otherwise healthy male and female undergoing surgical removal of both third mandibular molars. - Aged between 14 and 25 years. - Providing informed consent if 18yr and older, or parents/guardians providing informed consent otherwise Exclusion Criteria: - Subjects with gingival index (GI; according to Loe and Silness. 1963) or dental plaque index (PlI; according to Silness and Loe. 1964) above 2 in the CPI Community Periodontal Index) teeth subset. - Subjects having used probiotics or antibiotics within 30 days prior to study enrollment. - Tobacco use - Pregnant and breastfeeding women. - Known allergies to ingredients in study products. - Not willing to refrain from using mouthwashes during the study period |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Nens de Barcelona (Children's Hospital of Barcelona)) | Barcelona |
Lead Sponsor | Collaborator |
---|---|
AB Biotics, SA | Hospital de Nens de Barcelona |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complications derived from surgical removal of both mandibular third molars | Occurrence of low grade fever (Yes/No), oral alveolitis (Yes/No) and/or trismus (Yes/No), as determined by a trained specialist | 7 days | |
Secondary | Post-surgical pain, patient-rated | Oral pain derived from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary. | Daily, for 7 days | |
Secondary | Post-surgical swelling, patient-rated | Mandibular swelling derived from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary. | Daily, for 7 days | |
Secondary | Post-surgical eating difficulty, patient-rated | Eating difficulty as a result from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary. | Daily, for 7 days |
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