Overview

Probiotic Intervention After Surgical Removal of Mandibular Third Molars

Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AB Biotics, SA
Collaborator:
Hospital de Nens de Barcelona
Treatments:
Ibuprofen
Criteria
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