An interventional study of Impacted tooth extraction in Probiotics, Tooth, Impacted and Wound Heal, sponsored by University of Pisa. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University of Pisa · Not applicable, Interventional, and Other
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.
122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 88 interventional studies indexed under Tooth, Impacted.
Browse Tooth, Impacted studies →University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Procedure: 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).
Procedure: Impacted tooth extraction
All patients will undergo a surgical tooth extraction
Surgical 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
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Sep 2024, 41 months after the start.
Of 55 non-industry interventional studies with no phase under Tooth, Impacted, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 41 months is above that.
Counting every sponsor, half of 56 studies reached it within 20 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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