NCT04903925

Brief Summary

A randomized, double-blind, placebo-controlled clinical trial will be performed to assess the efficacy of a probiotic containing Lactobacillus reuteri in improving post-surgical wound healing after impacted tooth extractions. The Primary aim is to evaluate the efficacy of L. reuteri in improving post-extractive healing. The Secondary aim is to evaluate the efficacy of L. reuteri in association with an antibiotic therapy (amoxicillin) in reducing the incidence and severity of antibiotic-associated gastro-intestinal symptoms.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

3.4 years

First QC Date

May 18, 2021

Last Update Submit

May 8, 2024

Conditions

Gastrointestinal ComplicationProbioticsTooth, ImpactedWound Heal

Outcome Measures

Primary Outcomes (3)

  • Surgical wound healing

    Clinical assessment of the characteristics of the surgical wound

    3 days after the surgery

  • Surgical wound healing

    Clinical assessment of the characteristics of the surgical wound

    7 days after the surgery

  • Surgical wound healing

    Clinical assessment of the characteristics of the surgical wound

    14 days after the surgery

Secondary Outcomes (67)

  • Presence of pain

    3 days after the surgery

  • Presence of pain

    7 days after the surgery

  • Presence of pain

    14 days after the surgery

  • Abscess

    3 days after the surgery

  • Abscess

    7 days after the surgery

  • +62 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

All patients will undergo an impacted tooth extraction; patients allocated to group 1 will receive an antibiotic therapy with amoxicillin for 6 days (2 g/day) and a probiotic for 21 days (2 tablets/day).

Procedure: Impacted tooth extraction

Group 2

PLACEBO COMPARATOR

All patients will undergo an impacted tooth extraction; patients allocated to group 1 will receive an antibiotic therapy with amoxicillin for 6 days (2 g/day) and a placebo of the probiotic for 21 days (2 tablets/day).

Procedure: Impacted tooth extraction

Interventions

Impacted tooth extractionPROCEDURE

All patients will undergo a surgical tooth extraction

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • need for impacted tooth extractions
  • over age 18
  • ability to understand and to sign an informed consent form

You may not qualify if:

  • allergy to penicillin
  • contraindications to oral surgery
  • treatment with immunosuppressive agents or immunocompromised
  • treatment with amino-bisphosphonate and anti-angiogenetic medications
  • irradiation to head and neck area
  • uncontrolled diabetes
  • renal failure
  • drug and alcohol addiction
  • psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.O. Odontostomatologia e Chirurgia del Cavo Orale

Pisa, 56126, Italy

RECRUITING

Related Publications (1)

  • Cinquini C, Izzetti R, Nisi M, Gulia F, Garcia Mira B, Barone A. Limosilactobacillus reuteri Improves Healing Following Fully Impacted Tooth Extractions: Randomized Clinical Trial. Oral Dis. 2025 Jul 13. doi: 10.1111/odi.70026. Online ahead of print.

    PMID: 40652540DERIVED

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Antonio Barone, Professor

    University of Pisa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Barone, Professor

CONTACT

050993327antonio.barone@unipi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 27, 2021

Study Start

April 13, 2021

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)