NCT04203771

Probiotic Intervention After Surgical Removal of Mandibular Third Molars

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: All
• Age: 14 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgery--Complications
• Molar, Third

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic AB-DENTALAC	Orodispersible tablets containing Lactobacillus plantarum \[now Lactoplantibacillus plantarum\] KABP051 (CECT7481) and Lactobacillus brevis \[now Levilactobacillus brevis\] KABP052 (CECT7480) as active ingredients, at a minimum dose of 5x10\^8 cfu each, and sorbitol (E420) and guar gum (E412) as excipients, taken b.i.d. for 7 days.
OTHER	Placebo	Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.
PROCEDURE	Surgical removal of mandibular third molars at baseline	Surgical removal of both mandibular third molars, performed under intravenous sedation and loco-regional anesthesia (Articaine Hydrochloride 4% with Epinephrine 1:100.000), after having undergone a professional oral cleaning.
DRUG	Ibuprofen	Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2019-12-18
• Last updated: 2020-05-06

Locations

1 site across 1 country: Spain