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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
150
All patients will undergo a surgical tooth extraction
U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, Italy
RECRUITINGSurgical wound healing
Clinical assessment of the characteristics of the surgical wound
Time frame: 3 days after the surgery
Surgical wound healing
Clinical assessment of the characteristics of the surgical wound
Time frame: 7 days after the surgery
Surgical wound healing
Clinical assessment of the characteristics of the surgical wound
Time frame: 14 days after the surgery
Presence of pain
presence of pain assessed by VAS (0-10)
Time frame: 3 days after the surgery
Presence of pain
presence of pain assessed by VAS (0-10)
Time frame: 7 days after the surgery
Presence of pain
presence of pain assessed by VAS (0-10)
Time frame: 14 days after the surgery
Abscess
presence of suppuration
Time frame: 3 days after the surgery
Abscess
presence of suppuration
Time frame: 7 days after the surgery
Abscess
presence of suppuration
Time frame: 14 days after the surgery
Edema
presence and evaluation of the post-operative edema (intra-oral and extra-oral)
Time frame: 3 days after the surgery
Edema
presence and evaluation of the post-operative edema (intra-oral and extra-oral)
Time frame: 7 days after the surgery
Edema
presence and evaluation of the post-operative edema (intra-oral and extra-oral)
Time frame: 14 days after the surgery
Fever
Body temperature \> 37°C
Time frame: 3 days after the surgery
Fever
Body temperature \> 37°C
Time frame: 7 days after the surgery
Fever
Body temperature \> 37°C
Time frame: 14 days after the surgery
Alveolar osteitis
Presence of alveolar osteitis
Time frame: 3 days after the surgery
Alveolar osteitis
Presence of alveolar osteitis
Time frame: 7 days after the surgery
Alveolar osteitis
Presence of alveolar osteitis
Time frame: 14 days after the surgery
Trismus
reduction in mouth opening (measured in mm)
Time frame: 3 days after the surgery
Trismus
reduction in mouth opening (measured in mm)
Time frame: 7 days after the surgery
Trismus
reduction in mouth opening (measured in mm)
Time frame: 14 days after the surgery
Painkillers
Number of painkillers assumed in the first 7 days after the surgery
Time frame: 7 days after the surgery
bleeding on palpation
presence of bleeding on palpation
Time frame: 3 days after the surgery
bleeding on palpation
presence of bleeding on palpation
Time frame: 7 days after the surgery
bleeding on palpation
presence of bleeding on palpation
Time frame: 14 days after the surgery
Difficulty in chewing
Difficulty in chewing assessed by VAS (0-10)
Time frame: 3 days after the surgery
Difficulty in chewing
Difficulty in chewing assessed by VAS (0-10)
Time frame: 7 days after the surgery
Difficulty in chewing
Difficulty in chewing assessed by VAS (0-10)
Time frame: 14 days after the surgery
Difficulty in speaking
Difficulty in speaking assessed by VAS (0-10)
Time frame: 3 days after the surgery
Difficulty in speaking
Difficulty in speaking assessed by VAS (0-10)
Time frame: 7 days after the surgery
Difficulty in speaking
Difficulty in speaking assessed by VAS (0-10)
Time frame: 14 days after the surgery
Difficulty in performing oral hygiene
Difficulty in performing oral hygiene assessed by VAS (0-10)
Time frame: 3 days after the surgery
Difficulty in performing oral hygiene
Difficulty in performing oral hygiene assessed by VAS (0-10)
Time frame: 7 days after the surgery
Difficulty in performing oral hygiene
Difficulty in performing oral hygiene assessed by VAS (0-10)
Time frame: 14 days after the surgery
Daily routine alterations
days of stay off work
Time frame: 3 days after the surgery
Daily routine alterations
days of stay off work
Time frame: 7 days after the surgery
Daily routine alterations
days of stay off work
Time frame: 14 days after the surgery
Sensation of swelling
assessed by VAS (0-10)
Time frame: 3 days after the surgery
Sensation of swelling
assessed by VAS (0-10)
Time frame: 7 days after the surgery
Sensation of swelling
assessed by VAS (0-10)
Time frame: 14 days after the surgery
Number of disturbed-sleep nights following the extraction
Number of disturbed-sleep nights
Time frame: 3 days after the surgery
Number of disturbed-sleep nights following the extraction
Number of disturbed-sleep nights
Time frame: 7 days after the surgery
Number of disturbed-sleep nights following the extraction
Number of disturbed-sleep nights
Time frame: 14 days after the surgery
Abdominal pain
presence of Abdominal pain (questionnarie Y/N)
Time frame: 3 days after the surgery
Abdominal pain
presence of Abdominal pain (questionnarie Y/N)
Time frame: 7 days after the surgery
Abdominal pain
presence of Abdominal pain (questionnarie Y/N)
Time frame: 14 days after the surgery
Abdominal distension
presence of Abdominal pain (questionnarie Y/N)
Time frame: 3 days after the surgery
Abdominal distension
presence of Abdominal pain (questionnarie Y/N)
Time frame: 7 days after the surgery
Abdominal distension
presence of Abdominal pain (questionnarie Y/N)
Time frame: 14 days after the surgery
Alvus variation
presence of alvus variations (questionnarie Y/N)
Time frame: 3 days after the surgery
Alvus variation
presence of alvus variations (questionnarie Y/N)
Time frame: 7 days after the surgery
Alvus variation
presence of alvus variations (questionnarie Y/N)
Time frame: 14 days after the surgery
Nausea
presence of nausea (questionnarie Y/N)
Time frame: 3 days after the surgery
Nausea
presence of nausea (questionnarie Y/N)
Time frame: 7 days after the surgery
Nausea
presence of nausea (questionnarie Y/N)
Time frame: 14 days after the surgery
Vomit
presence of vomit (questionnarie Y/N)
Time frame: 3 days after the surgery
Vomit
presence of vomit (questionnarie Y/N)
Time frame: 7 days after the surgery
Vomit
presence of vomit (questionnarie Y/N)
Time frame: 14 days after the surgery
Acid reflux
presence of acid reflux (questionnarie Y/N)
Time frame: 3 days after the surgery
Acid reflux
presence of acid reflux (questionnarie Y/N)
Time frame: 7 days after the surgery
Acid reflux
presence of acid reflux (questionnarie Y/N)
Time frame: 14 days after the surgery
Gastric acidity
presence of gastric acidity (questionnarie Y/N)
Time frame: 3 days after the surgery
Gastric acidity
presence of gastric acidity (questionnarie Y/N)
Time frame: 7 days after the surgery
Gastric acidity
presence of gastric acidity (questionnarie Y/N)
Time frame: 14 days after the surgery
Gastric pain
presence of gastric pain (questionnarie Y/N)
Time frame: 3 days after the surgery
Gastric pain
presence of gastric pain (questionnarie Y/N)
Time frame: 7 days after the surgery
Gastric pain
presence of gastric pain (questionnarie Y/N)
Time frame: 14 days after the surgery
Loss of appetite
presence of loss of appetite (questionnarie Y/N)
Time frame: 3 days after the surgery
Loss of appetite
presence of loss of appetite (questionnarie Y/N)
Time frame: 7 days after the surgery
Loss of appetite
presence of loss of appetite (questionnarie Y/N)
Time frame: 14 days after the surgery
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