Probiotics for Improving Post-surgical Healing

NCT ID: NCT04903925

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2024-12-31

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.

Detailed Description

Probiotics are defined by the World Health Organization as "live microorganisms which, when administered in adequate amounts, confer a health benefit on the host." Human microbiome is a complex system that contributes to maintaining a good health status in humans. Broad-spectrum antibiotic therapies act against pathogen bacteria but also affect the intestinal microbiome, leading to different side effects such as abdominal pain, gastric pain, nausea, vomit and diarrhea.

The use of probiotics has been advocated as a possible means in reducing intensity and incidence of the symptoms related to antibiotic therapies. Some probiotics like Lactobacillus reuteri (L. reuteri) showed good anti-inflammatory properties and also antimicrobic action, assuming a possible role in wound healing processes.

Few studies have been conducted on the use of L. reuteri in dentistry. Twetman et al. (2018) conducted a trial to assess the efficacy of L. reuteri in improving post-surgical healing in the oral cavity after a punch biopsy, showing promising results. The authors concluded that larger trials may be useful to better clarify the role of probiotics in oral wounds healing. The only data regarding the possible role of L. reuteri in post- extractive healing comes from a pilot study (Walivara at al. 2019) that showed a reduction of the perceived swelling and of the number of disturbed-sleep nights in patients who underwent impacted-tooth extraction and assumed L. reuteri. Authors concluded that larger trials with closer follow-up visits are required to fully understand the clinical correlation.

The primary aim of the present research is to evaluate the efficacy of a probiotic containing L. reuteri in improving post-surgical healing following impacted tooth extractions and the secondary aim is to investigate its possible role in preventing or reducing gastro-intestinal side effects related to post-operative antibiotic therapy.A Randomized, double-blind, placebo-controlled clinical trial will be performed to evaluate the efficacy of L. reuteri in improving post-extractive healing.

All patients who need impacted tooth extractions at University Hospital of Pisa (Operative Unit of Odontostomatology and Oral Surgery) will be considered eligible for the study.

The number of patients to include is set to 160, divided in two experimental groups (80 patients per group). Patients who meet inclusion/exclusion criteria will be enrolled in this trial.

Conditions

Probiotics; Tooth, Impacted; Wound Heal; Gastrointestinal Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

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).

Group Type: EXPERIMENTAL

Impacted tooth extraction

Intervention Type: PROCEDURE

All patients will undergo a surgical tooth extraction

Group 2

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).

Group Type: PLACEBO_COMPARATOR

Impacted tooth extraction

Intervention Type: PROCEDURE

All patients will undergo a surgical tooth extraction

Interventions

Impacted tooth extraction

All patients will undergo a surgical tooth extraction

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Antonio Barone

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Barone, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

U.O. Odontostomatologia e Chirurgia del Cavo Orale

Pisa, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Barone, Professor

Role: CONTACT

antonio.barone@unipi.it

050993327

Facility Contacts

Antonio Barone, Professor

Role: primary

antonio.barone@unipi.it

050993327

References

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.

Reference Type: DERIVED

PMID: 40652540 (View on PubMed)

Other Identifiers

Antib Prob Impacted 1

Identifier Type: -

Identifier Source: org_study_id