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
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.
This was a single-centre, prospective, double-blind, randomized, placebo-controlled,
parallel-group study to evaluate whether probiotic supplementation during 1 week after
surgery reduced post-surgery complications compared to placebo.
Healthy subjects of both genders aged between 14 and 25 years who required the surgical
removal of both mandibular 3rd molars were recruited from the department of Oral and
Maxillofacial Surgery at the Foundation of Hospital de Nens de Barcelona (Children's Hospital
of Barcelona).
Patients were randomly assigned to receive probiotic tablets containing a mixture of L.
plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) or to receive placebo, twice
a day for 7 days post surgery.
Patients were assessed by trained specialists for surgery-derived complications (fever, oral
alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. Patients
also provided daily evaluations for pain, swelling and eating difficulties in a patient
diary.
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