Probiotics for Improving Post-surgical Healing

Not Applicable

Recruiting

• Conditions: Probiotics; Wound Heal; Gastrointestinal Complication; Tooth, Impacted
• Interventions: Procedure: Impacted tooth extraction

• Registration Number: NCT04903925
• Lead Sponsor: University of Pisa

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.

Study Timeline

• Study Start: 2021-04-13
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Impacted tooth extraction	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 1	Impacted tooth extraction	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).

Primary Outcome Measures

Name	Time	Method
Surgical wound healing	14 days after the surgery	Clinical assessment of the characteristics of the surgical wound

Secondary Outcome Measures

Name	Time	Method
Alveolar osteitis	14 days after the surgery	Presence of alveolar osteitis
Fever	14 days after the surgery	Body temperature \> 37°C
Presence of pain	14 days after the surgery	presence of pain assessed by VAS (0-10)
Abscess	14 days after the surgery	presence of suppuration
Edema	14 days after the surgery	presence and evaluation of the post-operative edema (intra-oral and extra-oral)
Trismus	14 days after the surgery	reduction in mouth opening (measured in mm)
bleeding on palpation	14 days after the surgery	presence of bleeding on palpation
Painkillers	7 days after the surgery	Number of painkillers assumed in the first 7 days after the surgery
Difficulty in chewing	14 days after the surgery	Difficulty in chewing assessed by VAS (0-10)
Difficulty in speaking	14 days after the surgery	Difficulty in speaking assessed by VAS (0-10)
Abdominal distension	14 days after the surgery	presence of Abdominal pain (questionnarie Y/N)
Nausea	14 days after the surgery	presence of nausea (questionnarie Y/N)
Difficulty in performing oral hygiene	14 days after the surgery	Difficulty in performing oral hygiene assessed by VAS (0-10)
Daily routine alterations	14 days after the surgery	days of stay off work
Number of disturbed-sleep nights following the extraction	14 days after the surgery	Number of disturbed-sleep nights
Vomit	14 days after the surgery	presence of vomit (questionnarie Y/N)
Gastric acidity	14 days after the surgery	presence of gastric acidity (questionnarie Y/N)
Loss of appetite	14 days after the surgery	presence of loss of appetite (questionnarie Y/N)
Sensation of swelling	14 days after the surgery	assessed by VAS (0-10)
Abdominal pain	14 days after the surgery	presence of Abdominal pain (questionnarie Y/N)
Alvus variation	14 days after the surgery	presence of alvus variations (questionnarie Y/N)
Acid reflux	14 days after the surgery	presence of acid reflux (questionnarie Y/N)
Gastric pain	14 days after the surgery	presence of gastric pain (questionnarie Y/N)

Trial Locations

Locations (1)

U.O. Odontostomatologia e Chirurgia del Cavo Orale; 🇮🇹 Pisa, Italy