Gastrointestinal Complication, Probiotics, Tooth, Impacted, Wound Heal
Conditions
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.
Interventions
PROCEDUREImpacted tooth extraction
All patients will undergo a surgical tooth extraction
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical wound healing | 3 days after the surgery | Clinical assessment of the characteristics of the surgical wound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal pain | 3 days after the surgery | presence of Abdominal pain (questionnarie Y/N) |
| Presence of pain | 3 days after the surgery | presence of pain assessed by VAS (0-10) |
| Abscess | 3 days after the surgery | presence of suppuration |
| Edema | 3 days after the surgery | presence and evaluation of the post-operative edema (intra-oral and extra-oral) |
| Fever | 3 days after the surgery | Body temperature \> 37°C |
| Alveolar osteitis | 3 days after the surgery | Presence of alveolar osteitis |
| Trismus | 3 days after the surgery | reduction in mouth opening (measured in mm) |
| Painkillers | 7 days after the surgery | Number of painkillers assumed in the first 7 days after the surgery |
| bleeding on palpation | 3 days after the surgery | presence of bleeding on palpation |
| Difficulty in chewing | 3 days after the surgery | Difficulty in chewing assessed by VAS (0-10) |
| Difficulty in speaking | 3 days after the surgery | Difficulty in speaking assessed by VAS (0-10) |
| Number of disturbed-sleep nights following the extraction | 3 days after the surgery | Number of disturbed-sleep nights |
| Daily routine alterations | 3 days after the surgery | days of stay off work |
| Sensation of swelling | 3 days after the surgery | assessed by VAS (0-10) |
| Abdominal distension | 3 days after the surgery | presence of Abdominal pain (questionnarie Y/N) |
| Alvus variation | 3 days after the surgery | presence of alvus variations (questionnarie Y/N) |
| Nausea | 3 days after the surgery | presence of nausea (questionnarie Y/N) |
| Vomit | 3 days after the surgery | presence of vomit (questionnarie Y/N) |
| Acid reflux | 3 days after the surgery | presence of acid reflux (questionnarie Y/N) |
| Gastric acidity | 3 days after the surgery | presence of gastric acidity (questionnarie Y/N) |
| Gastric pain | 3 days after the surgery | presence of gastric pain (questionnarie Y/N) |
| Loss of appetite | 3 days after the surgery | presence of loss of appetite (questionnarie Y/N) |
| Difficulty in performing oral hygiene | 3 days after the surgery | Difficulty in performing oral hygiene assessed by VAS (0-10) |
Countries
Italy
Contacts
Primary ContactAntonio Barone, Professor
Outcome results
None listed