Probiotics for Improving Post-surgical Healing

Wound Heal Clinical Trial

Official title:

Efficacy of Probiotics in Improving Post-surgical Healing for Impacted Tooth Extractions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04903925
• Other study ID #: Antib Prob Impacted 1
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Pisa
• Contact: Antonio Barone, Professor
• Phone: 050993327
• Email: antonio.barone[@]unipi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Complication
• Probiotics
• Tooth, Impacted
• Wound Heal

Intervention

Procedure:
• Impacted tooth extraction
All patients will undergo a surgical tooth extraction

Locations

Country	Name	City	State
Italy	U.O. Odontostomatologia e Chirurgia del Cavo Orale	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical wound healing	Clinical assessment of the characteristics of the surgical wound	3 days after the surgery
Primary	Surgical wound healing	Clinical assessment of the characteristics of the surgical wound	7 days after the surgery
Primary	Surgical wound healing	Clinical assessment of the characteristics of the surgical wound	14 days after the surgery
Secondary	Presence of pain	presence of pain assessed by VAS (0-10)	3 days after the surgery
Secondary	Presence of pain	presence of pain assessed by VAS (0-10)	7 days after the surgery
Secondary	Presence of pain	presence of pain assessed by VAS (0-10)	14 days after the surgery
Secondary	Abscess	presence of suppuration	3 days after the surgery
Secondary	Abscess	presence of suppuration	7 days after the surgery
Secondary	Abscess	presence of suppuration	14 days after the surgery
Secondary	Edema	presence and evaluation of the post-operative edema (intra-oral and extra-oral)	3 days after the surgery
Secondary	Edema	presence and evaluation of the post-operative edema (intra-oral and extra-oral)	7 days after the surgery
Secondary	Edema	presence and evaluation of the post-operative edema (intra-oral and extra-oral)	14 days after the surgery
Secondary	Fever	Body temperature > 37°C	3 days after the surgery
Secondary	Fever	Body temperature > 37°C	7 days after the surgery
Secondary	Fever	Body temperature > 37°C	14 days after the surgery
Secondary	Alveolar osteitis	Presence of alveolar osteitis	3 days after the surgery
Secondary	Alveolar osteitis	Presence of alveolar osteitis	7 days after the surgery
Secondary	Alveolar osteitis	Presence of alveolar osteitis	14 days after the surgery
Secondary	Trismus	reduction in mouth opening (measured in mm)	3 days after the surgery
Secondary	Trismus	reduction in mouth opening (measured in mm)	7 days after the surgery
Secondary	Trismus	reduction in mouth opening (measured in mm)	14 days after the surgery
Secondary	Painkillers	Number of painkillers assumed in the first 7 days after the surgery	7 days after the surgery
Secondary	bleeding on palpation	presence of bleeding on palpation	3 days after the surgery
Secondary	bleeding on palpation	presence of bleeding on palpation	7 days after the surgery
Secondary	bleeding on palpation	presence of bleeding on palpation	14 days after the surgery
Secondary	Difficulty in chewing	Difficulty in chewing assessed by VAS (0-10)	3 days after the surgery
Secondary	Difficulty in chewing	Difficulty in chewing assessed by VAS (0-10)	7 days after the surgery
Secondary	Difficulty in chewing	Difficulty in chewing assessed by VAS (0-10)	14 days after the surgery
Secondary	Difficulty in speaking	Difficulty in speaking assessed by VAS (0-10)	3 days after the surgery
Secondary	Difficulty in speaking	Difficulty in speaking assessed by VAS (0-10)	7 days after the surgery
Secondary	Difficulty in speaking	Difficulty in speaking assessed by VAS (0-10)	14 days after the surgery
Secondary	Difficulty in performing oral hygiene	Difficulty in performing oral hygiene assessed by VAS (0-10)	3 days after the surgery
Secondary	Difficulty in performing oral hygiene	Difficulty in performing oral hygiene assessed by VAS (0-10)	7 days after the surgery
Secondary	Difficulty in performing oral hygiene	Difficulty in performing oral hygiene assessed by VAS (0-10)	14 days after the surgery
Secondary	Daily routine alterations	days of stay off work	3 days after the surgery
Secondary	Daily routine alterations	days of stay off work	7 days after the surgery
Secondary	Daily routine alterations	days of stay off work	14 days after the surgery
Secondary	Sensation of swelling	assessed by VAS (0-10)	3 days after the surgery
Secondary	Sensation of swelling	assessed by VAS (0-10)	7 days after the surgery
Secondary	Sensation of swelling	assessed by VAS (0-10)	14 days after the surgery
Secondary	Number of disturbed-sleep nights following the extraction	Number of disturbed-sleep nights	3 days after the surgery
Secondary	Number of disturbed-sleep nights following the extraction	Number of disturbed-sleep nights	7 days after the surgery
Secondary	Number of disturbed-sleep nights following the extraction	Number of disturbed-sleep nights	14 days after the surgery
Secondary	Abdominal pain	presence of Abdominal pain (questionnarie Y/N)	3 days after the surgery
Secondary	Abdominal pain	presence of Abdominal pain (questionnarie Y/N)	7 days after the surgery
Secondary	Abdominal pain	presence of Abdominal pain (questionnarie Y/N)	14 days after the surgery
Secondary	Abdominal distension	presence of Abdominal pain (questionnarie Y/N)	3 days after the surgery
Secondary	Abdominal distension	presence of Abdominal pain (questionnarie Y/N)	7 days after the surgery
Secondary	Abdominal distension	presence of Abdominal pain (questionnarie Y/N)	14 days after the surgery
Secondary	Alvus variation	presence of alvus variations (questionnarie Y/N)	3 days after the surgery
Secondary	Alvus variation	presence of alvus variations (questionnarie Y/N)	7 days after the surgery
Secondary	Alvus variation	presence of alvus variations (questionnarie Y/N)	14 days after the surgery
Secondary	Nausea	presence of nausea (questionnarie Y/N)	3 days after the surgery
Secondary	Nausea	presence of nausea (questionnarie Y/N)	7 days after the surgery
Secondary	Nausea	presence of nausea (questionnarie Y/N)	14 days after the surgery
Secondary	Vomit	presence of vomit (questionnarie Y/N)	3 days after the surgery
Secondary	Vomit	presence of vomit (questionnarie Y/N)	7 days after the surgery
Secondary	Vomit	presence of vomit (questionnarie Y/N)	14 days after the surgery
Secondary	Acid reflux	presence of acid reflux (questionnarie Y/N)	3 days after the surgery
Secondary	Acid reflux	presence of acid reflux (questionnarie Y/N)	7 days after the surgery
Secondary	Acid reflux	presence of acid reflux (questionnarie Y/N)	14 days after the surgery
Secondary	Gastric acidity	presence of gastric acidity (questionnarie Y/N)	3 days after the surgery
Secondary	Gastric acidity	presence of gastric acidity (questionnarie Y/N)	7 days after the surgery
Secondary	Gastric acidity	presence of gastric acidity (questionnarie Y/N)	14 days after the surgery
Secondary	Gastric pain	presence of gastric pain (questionnarie Y/N)	3 days after the surgery
Secondary	Gastric pain	presence of gastric pain (questionnarie Y/N)	7 days after the surgery
Secondary	Gastric pain	presence of gastric pain (questionnarie Y/N)	14 days after the surgery
Secondary	Loss of appetite	presence of loss of appetite (questionnarie Y/N)	3 days after the surgery
Secondary	Loss of appetite	presence of loss of appetite (questionnarie Y/N)	7 days after the surgery
Secondary	Loss of appetite	presence of loss of appetite (questionnarie Y/N)	14 days after the surgery