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

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.

Study Overview

• Status: Completed
• Conditions: Surgery--Complications; Molar, Third
• Intervention / Treatment: Dietary supplement: Probiotic AB-DENTALAC; Procedure: Surgical removal of mandibular third molars at baseline; Drug: Ibuprofen; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08009
    • Hospital de Nens de Barcelona (Children's Hospital of Barcelona))

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; Orodispersible tablets containing AB-DENTALAC probiotic formula.	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.; 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; Other Names: Dalsy
Placebo Comparator: Control; Orodispersible tablets without probiotic strains (excipients only).	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; Other Names: Dalsy; Other: Placebo; Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: AB Biotics, SA
• Collaborators: Hospital de Nens de Barcelona
• Investigators: Principal Investigator: Eduard Ferres Padro, MD, Children's Hospital of Barcelona; Study Chair: Jordi Espadaler Mazo, PhD, AB Biotics, SA

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Probiotic; Molar removal surgery; Oral pain; Maxillofacial surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: PB-0202015-FHNB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No