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Probiotic Intervention After Surgical Removal of Mandibular Third Molars

NCT04203771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-05-06

No results posted yet for this study

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.

Conditions

  • Surgery--Complications
  • Molar, Third

Interventions

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

Sponsors & Collaborators

  • Hospital de Nens de Barcelona

    collaborator OTHER

  • AB Biotics, SA

    lead INDUSTRY

Principal Investigators

  • Eduard Ferres Padro, MD · Children's Hospital of Barcelona

  • Jordi Espadaler Mazo, PhD · AB Biotics, SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-04-30
Completion
2017-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203771 on ClinicalTrials.gov