Clinical trial NCT04903925: Probiotics for Improving Post-surgical Healing
Official title: Efficacy of Probiotics in Improving Post-surgical Healing for Impacted Tooth Extractions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Probiotics
Tooth, Impacted
Wound Heal
Gastrointestinal Complication
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Surgical wound healing
timeFrame: 3 days after the surgery
measure: Surgical wound healing
timeFrame: 7 days after the surgery
measure: Surgical wound healing
timeFrame: 14 days after the surgery
Secondary outcomes:
measure: Presence of pain
timeFrame: 3 days after the surgery
measure: Presence of pain
timeFrame: 7 days after the surgery
measure: Presence of pain
timeFrame: 14 days after the surgery
measure: Abscess
timeFrame: 3 days after the surgery
measure: Abscess
timeFrame: 7 days after the surgery
measure: Abscess
timeFrame: 14 days after the surgery
measure: Edema
timeFrame: 3 days after the surgery
measure: Edema
timeFrame: 7 days after the surgery
measure: Edema
timeFrame: 14 days after the surgery
measure: Fever
timeFrame: 3 days after the surgery
measure: Fever
timeFrame: 7 days after the surgery
measure: Fever
timeFrame: 14 days after the surgery
measure: Alveolar osteitis
timeFrame: 3 days after the surgery
measure: Alveolar osteitis
timeFrame: 7 days after the surgery
measure: Alveolar osteitis
timeFrame: 14 days after the surgery
measure: Trismus
timeFrame: 3 days after the surgery
measure: Trismus
timeFrame: 7 days after the surgery
measure: Trismus
timeFrame: 14 days after the surgery
measure: Painkillers
timeFrame: 7 days after the surgery
measure: bleeding on palpation
timeFrame: 3 days after the surgery
measure: bleeding on palpation
timeFrame: 7 days after the surgery
measure: bleeding on palpation
timeFrame: 14 days after the surgery
measure: Difficulty in chewing
timeFrame: 3 days after the surgery
measure: Difficulty in chewing
timeFrame: 7 days after the surgery
measure: Difficulty in chewing
timeFrame: 14 days after the surgery
measure: Difficulty in speaking
timeFrame: 3 days after the surgery
measure: Difficulty in speaking
timeFrame: 7 days after the surgery
measure: Difficulty in speaking
timeFrame: 14 days after the surgery
measure: Difficulty in performing oral hygiene
timeFrame: 3 days after the surgery
measure: Difficulty in performing oral hygiene
timeFrame: 7 days after the surgery
measure: Difficulty in performing oral hygiene
timeFrame: 14 days after the surgery
measure: Daily routine alterations
timeFrame: 3 days after the surgery
measure: Daily routine alterations
timeFrame: 7 days after the surgery
measure: Daily routine alterations
timeFrame: 14 days after the surgery
measure: Sensation of swelling
timeFrame: 3 days after the surgery
measure: Sensation of swelling
timeFrame: 7 days after the surgery
measure: Sensation of swelling
timeFrame: 14 days after the surgery
measure: Number of disturbed-sleep nights following the extraction
timeFrame: 3 days after the surgery
measure: Number of disturbed-sleep nights following the extraction
timeFrame: 7 days after the surgery
measure: Number of disturbed-sleep nights following the extraction
timeFrame: 14 days after the surgery
measure: Abdominal pain
timeFrame: 3 days after the surgery
measure: Abdominal pain
timeFrame: 7 days after the surgery
measure: Abdominal pain
timeFrame: 14 days after the surgery
measure: Abdominal distension
timeFrame: 3 days after the surgery
measure: Abdominal distension
timeFrame: 7 days after the surgery
measure: Abdominal distension
timeFrame: 14 days after the surgery
measure: Alvus variation
timeFrame: 3 days after the surgery
measure: Alvus variation
timeFrame: 7 days after the surgery
measure: Alvus variation
timeFrame: 14 days after the surgery
measure: Nausea
timeFrame: 3 days after the surgery
measure: Nausea
timeFrame: 7 days after the surgery
measure: Nausea
timeFrame: 14 days after the surgery
measure: Vomit
timeFrame: 3 days after the surgery
measure: Vomit
timeFrame: 7 days after the surgery
measure: Vomit
timeFrame: 14 days after the surgery
measure: Acid reflux
timeFrame: 3 days after the surgery
measure: Acid reflux
timeFrame: 7 days after the surgery
measure: Acid reflux
timeFrame: 14 days after the surgery
measure: Gastric acidity
timeFrame: 3 days after the surgery
measure: Gastric acidity
timeFrame: 7 days after the surgery
measure: Gastric acidity
timeFrame: 14 days after the surgery
measure: Gastric pain
timeFrame: 3 days after the surgery
measure: Gastric pain
timeFrame: 7 days after the surgery
measure: Gastric pain
timeFrame: 14 days after the surgery
measure: Loss of appetite
timeFrame: 3 days after the surgery
measure: Loss of appetite
timeFrame: 7 days after the surgery
measure: Loss of appetite
timeFrame: 14 days after the surgery
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale
Study officials:
affiliation: University of Pisa
name: Antonio Barone, Professor
role: PRINCIPAL_INVESTIGATOR
References: