NCT04203771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

December 17, 2019

Last Update Submit

May 5, 2020

Conditions

Surgery--ComplicationsMolar, Third

Keywords

ProbioticMolar removal surgeryOral painMaxillofacial surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Post-surgical pain, patient-rated

    Daily, for 7 days

  • Post-surgical swelling, patient-rated

    Daily, for 7 days

  • Post-surgical eating difficulty, patient-rated

    Daily, for 7 days

Study Arms (2)

Probiotic

EXPERIMENTAL

Orodispersible tablets containing AB-DENTALAC probiotic formula.

Dietary Supplement: Probiotic AB-DENTALACProcedure: Surgical removal of mandibular third molars at baselineDrug: Ibuprofen

Control

PLACEBO COMPARATOR

Orodispersible tablets without probiotic strains (excipients only).

Other: PlaceboProcedure: Surgical removal of mandibular third molars at baselineDrug: Ibuprofen

Interventions

Probiotic AB-DENTALACDIETARY_SUPPLEMENT

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.

Probiotic
PlaceboOTHER

Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.

Control
Surgical removal of mandibular third molars at baselinePROCEDURE

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.

ControlProbiotic
IbuprofenDRUG

Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days

Also known as: Dalsy
ControlProbiotic

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Nens de Barcelona (Children's Hospital of Barcelona))

Barcelona, 08009, Spain

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Eduard Ferres Padro, MD

    Children's Hospital of Barcelona

    PRINCIPAL INVESTIGATOR

  • Jordi Espadaler Mazo, PhD

    AB Biotics, SA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Probiotic and placebo tablets with identical appearance were provided in anonymous packages to the investigators, solely labelled with the volunteer's randomization number
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 18, 2019

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)