Clinical trial NCT04203771: Probiotic Intervention After Surgical Removal of Mandibular Third Molars
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery--Complications
Molar, Third
Keywords: Probiotic
Molar removal surgery
Oral pain
Maxillofacial surgery
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
Collaborators: name: Hospital de Nens de Barcelona
First posted: 2019-12-18
Enrollment: 38
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Complications derived from surgical removal of both mandibular third molars
timeFrame: 7 days
Secondary outcomes:
measure: Post-surgical pain, patient-rated
timeFrame: Daily, for 7 days
measure: Post-surgical swelling, patient-rated
timeFrame: Daily, for 7 days
measure: Post-surgical eating difficulty, patient-rated
timeFrame: Daily, for 7 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de Nens de Barcelona (Children's Hospital of Barcelona))
Study officials:
affiliation: Children's Hospital of Barcelona
name: Eduard Ferres Padro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AB Biotics, SA
name: Jordi Espadaler Mazo, PhD
role: STUDY_CHAIR
References: