ProbioticsNCT04903925
Probiotics for Improving Post-surgical Healing
A study testing Impacted tooth extraction in people with Probiotics and Tooth, Impacted, run by University of Pisa at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Probiotics, Tooth, Impacted, Wound Heal
- What is being tested?
- Impacted tooth extraction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- need for impacted tooth extractions
- over age 18
- ability to understand and to sign an informed consent form
Who cannot join
- 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
Show all 9Show fewer
- renal failure
- drug and alcohol addiction
- psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, 56126
Antonio Barone, Professor, 050993327, antonio.barone@unipi.it
About this study
Official title: Efficacy of Probiotics in Improving Post-surgical Healing for Impacted Tooth Extractions
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.
Read the 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.
- Conditions
- Probiotics, Tooth, Impacted, Wound Heal, Gastrointestinal Complication
- Being tested
- Impacted tooth extraction
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacted tooth extractionProcedure or surgery
All patients will undergo a surgical tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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). Receives: Procedure: Impacted tooth extraction |
| Group 2 | Placebo comparator | 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). Receives: Procedure: Impacted tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical wound healing
Clinical assessment of the characteristics of the surgical wound
Measured: 3 days after the surgery
Surgical wound healing
Clinical assessment of the characteristics of the surgical wound
Measured: 7 days after the surgery
Surgical wound healing
Clinical assessment of the characteristics of the surgical wound
Measured: 14 days after the surgery
Secondary outcomes (67)
Presence of pain
presence of pain assessed by VAS (0-10)
Measured: 3 days after the surgery
Presence of pain
presence of pain assessed by VAS (0-10)
Measured: 7 days after the surgery
Presence of pain
presence of pain assessed by VAS (0-10)
Measured: 14 days after the surgery
Abscess
presence of suppuration
Measured: 3 days after the surgery
Abscess
presence of suppuration
Measured: 7 days after the surgery
Abscess
presence of suppuration
Measured: 14 days after the surgery
Edema
presence and evaluation of the post-operative edema (intra-oral and extra-oral)
Measured: 3 days after the surgery
Edema
presence and evaluation of the post-operative edema (intra-oral and extra-oral)
Measured: 7 days after the surgery
Edema
presence and evaluation of the post-operative edema (intra-oral and extra-oral)
Measured: 14 days after the surgery
Fever
Body temperature > 37°C
Measured: 3 days after the surgery
Fever
Body temperature > 37°C
Measured: 7 days after the surgery
Fever
Body temperature > 37°C
Measured: 14 days after the surgery
Alveolar osteitis
Presence of alveolar osteitis
Measured: 3 days after the surgery
Alveolar osteitis
Presence of alveolar osteitis
Measured: 7 days after the surgery
Alveolar osteitis
Presence of alveolar osteitis
Measured: 14 days after the surgery
Trismus
reduction in mouth opening (measured in mm)
Measured: 3 days after the surgery
Trismus
reduction in mouth opening (measured in mm)
Measured: 7 days after the surgery
Trismus
reduction in mouth opening (measured in mm)
Measured: 14 days after the surgery
Painkillers
Number of painkillers assumed in the first 7 days after the surgery
Measured: 7 days after the surgery
bleeding on palpation
presence of bleeding on palpation
Measured: 3 days after the surgery
bleeding on palpation
presence of bleeding on palpation
Measured: 7 days after the surgery
bleeding on palpation
presence of bleeding on palpation
Measured: 14 days after the surgery
Difficulty in chewing
Difficulty in chewing assessed by VAS (0-10)
Measured: 3 days after the surgery
Difficulty in chewing
Difficulty in chewing assessed by VAS (0-10)
Measured: 7 days after the surgery
Difficulty in chewing
Difficulty in chewing assessed by VAS (0-10)
Measured: 14 days after the surgery
Difficulty in speaking
Difficulty in speaking assessed by VAS (0-10)
Measured: 3 days after the surgery
Difficulty in speaking
Difficulty in speaking assessed by VAS (0-10)
Measured: 7 days after the surgery
Difficulty in speaking
Difficulty in speaking assessed by VAS (0-10)
Measured: 14 days after the surgery
Difficulty in performing oral hygiene
Difficulty in performing oral hygiene assessed by VAS (0-10)
Measured: 3 days after the surgery
Difficulty in performing oral hygiene
Difficulty in performing oral hygiene assessed by VAS (0-10)
Measured: 7 days after the surgery
Difficulty in performing oral hygiene
Difficulty in performing oral hygiene assessed by VAS (0-10)
Measured: 14 days after the surgery
Daily routine alterations
days of stay off work
Measured: 3 days after the surgery
Daily routine alterations
days of stay off work
Measured: 7 days after the surgery
Daily routine alterations
days of stay off work
Measured: 14 days after the surgery
Sensation of swelling
assessed by VAS (0-10)
Measured: 3 days after the surgery
Sensation of swelling
assessed by VAS (0-10)
Measured: 7 days after the surgery
Sensation of swelling
assessed by VAS (0-10)
Measured: 14 days after the surgery
Number of disturbed-sleep nights following the extraction
Number of disturbed-sleep nights
Measured: 3 days after the surgery
Number of disturbed-sleep nights following the extraction
Number of disturbed-sleep nights
Measured: 7 days after the surgery
Number of disturbed-sleep nights following the extraction
Number of disturbed-sleep nights
Measured: 14 days after the surgery
Abdominal pain
presence of Abdominal pain (questionnarie Y/N)
Measured: 3 days after the surgery
Abdominal pain
presence of Abdominal pain (questionnarie Y/N)
Measured: 7 days after the surgery
Abdominal pain
presence of Abdominal pain (questionnarie Y/N)
Measured: 14 days after the surgery
Abdominal distension
presence of Abdominal pain (questionnarie Y/N)
Measured: 3 days after the surgery
Abdominal distension
presence of Abdominal pain (questionnarie Y/N)
Measured: 7 days after the surgery
Abdominal distension
presence of Abdominal pain (questionnarie Y/N)
Measured: 14 days after the surgery
Alvus variation
presence of alvus variations (questionnarie Y/N)
Measured: 3 days after the surgery
Alvus variation
presence of alvus variations (questionnarie Y/N)
Measured: 7 days after the surgery
Alvus variation
presence of alvus variations (questionnarie Y/N)
Measured: 14 days after the surgery
Nausea
presence of nausea (questionnarie Y/N)
Measured: 3 days after the surgery
Nausea
presence of nausea (questionnarie Y/N)
Measured: 7 days after the surgery
Nausea
presence of nausea (questionnarie Y/N)
Measured: 14 days after the surgery
Vomit
presence of vomit (questionnarie Y/N)
Measured: 3 days after the surgery
Vomit
presence of vomit (questionnarie Y/N)
Measured: 7 days after the surgery
Vomit
presence of vomit (questionnarie Y/N)
Measured: 14 days after the surgery
Acid reflux
presence of acid reflux (questionnarie Y/N)
Measured: 3 days after the surgery
Acid reflux
presence of acid reflux (questionnarie Y/N)
Measured: 7 days after the surgery
Acid reflux
presence of acid reflux (questionnarie Y/N)
Measured: 14 days after the surgery
Gastric acidity
presence of gastric acidity (questionnarie Y/N)
Measured: 3 days after the surgery
Gastric acidity
presence of gastric acidity (questionnarie Y/N)
Measured: 7 days after the surgery
Gastric acidity
presence of gastric acidity (questionnarie Y/N)
Measured: 14 days after the surgery
Gastric pain
presence of gastric pain (questionnarie Y/N)
Measured: 3 days after the surgery
Gastric pain
presence of gastric pain (questionnarie Y/N)
Measured: 7 days after the surgery
Gastric pain
presence of gastric pain (questionnarie Y/N)
Measured: 14 days after the surgery
Loss of appetite
presence of loss of appetite (questionnarie Y/N)
Measured: 3 days after the surgery
Loss of appetite
presence of loss of appetite (questionnarie Y/N)
Measured: 7 days after the surgery
Loss of appetite
presence of loss of appetite (questionnarie Y/N)
Measured: 14 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start13 Apr 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProbioticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Barone, University of Pisa
- Investigators
- Antonio Barone, Professor, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903925
- Sponsor's protocol ID
- Antib Prob Impacted 1
- Status last verified
- May 2024
- First submitted
- 18 May 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cinquini C, Izzetti R, Nisi M, Gulia F, Garcia Mira B, Barone A. Limosilactobacillus reuteri Improves Healing Following Fully Impacted Tooth Extractions: Randomized Clinical Trial. Oral Dis. 2025 Dec;31(12):3482-3494. doi: 10.1111/odi.70026. Epub 2025 Jul 13.
PubMed 40652540
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotics in Improving Post-surgical Healing for Impacted Tooth Extractions
- ClinicalTrials.gov ID
- NCT04903925
- Acronym / sponsor ID
- Antib Prob Impacted 1
- Conditions
- Probiotics, Tooth, Impacted, Wound Heal, Gastrointestinal Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Impacted tooth extractionAll 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). |
| Group 2 | Placebo comparator | Procedure: Impacted tooth extractionAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- need for impacted tooth extractions
- over age 18
- ability to understand and to sign an informed consent form
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impacted tooth extractionAll patients will undergo a surgical tooth extraction | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Surgical wound healing
Time frame: 3 days after the surgery
Clinical assessment of the characteristics of the surgical wound
Surgical wound healing
Time frame: 7 days after the surgery
Clinical assessment of the characteristics of the surgical wound
Surgical wound healing
Time frame: 14 days after the surgery
Clinical assessment of the characteristics of the surgical wound
67 secondary outcomes
Presence of pain
Time frame: 3 days after the surgery
Presence of pain
Time frame: 7 days after the surgery
Presence of pain
Time frame: 14 days after the surgery
Abscess
Time frame: 3 days after the surgery
Abscess
Time frame: 7 days after the surgery
Abscess
Time frame: 14 days after the surgery
Edema
Time frame: 3 days after the surgery
Edema
Time frame: 7 days after the surgery
Edema
Time frame: 14 days after the surgery
Fever
Time frame: 3 days after the surgery
Fever
Time frame: 7 days after the surgery
Fever
Time frame: 14 days after the surgery
Alveolar osteitis
Time frame: 3 days after the surgery
Alveolar osteitis
Time frame: 7 days after the surgery
Alveolar osteitis
Time frame: 14 days after the surgery
Trismus
Time frame: 3 days after the surgery
Trismus
Time frame: 7 days after the surgery
Trismus
Time frame: 14 days after the surgery
Painkillers
Time frame: 7 days after the surgery
bleeding on palpation
Time frame: 3 days after the surgery
bleeding on palpation
Time frame: 7 days after the surgery
bleeding on palpation
Time frame: 14 days after the surgery
Difficulty in chewing
Time frame: 3 days after the surgery
Difficulty in chewing
Time frame: 7 days after the surgery
Difficulty in chewing
Time frame: 14 days after the surgery
Difficulty in speaking
Time frame: 3 days after the surgery
Difficulty in speaking
Time frame: 7 days after the surgery
Difficulty in speaking
Time frame: 14 days after the surgery
Difficulty in performing oral hygiene
Time frame: 3 days after the surgery
Difficulty in performing oral hygiene
Time frame: 7 days after the surgery
Difficulty in performing oral hygiene
Time frame: 14 days after the surgery
Daily routine alterations
Time frame: 3 days after the surgery
Daily routine alterations
Time frame: 7 days after the surgery
Daily routine alterations
Time frame: 14 days after the surgery
Sensation of swelling
Time frame: 3 days after the surgery
Sensation of swelling
Time frame: 7 days after the surgery
Sensation of swelling
Time frame: 14 days after the surgery
Number of disturbed-sleep nights following the extraction
Time frame: 3 days after the surgery
Number of disturbed-sleep nights following the extraction
Time frame: 7 days after the surgery
Number of disturbed-sleep nights following the extraction
Time frame: 14 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 40652540Cinquini C, Izzetti R, Nisi M, Gulia F, Garcia Mira B, Barone A. Limosilactobacillus reuteri Improves Healing Following Fully Impacted Tooth Extractions: Randomized Clinical Trial. Oral Dis. 2025 Dec;31(12):3482-3494. doi: 10.1111/odi.70026. Epub 2025 Jul 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Barone, Professor principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impacted tooth extraction in people with Probiotics and Tooth, Impacted, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Barone, Professor (050993327, antonio.barone@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical wound healing (time frame: 3 days after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.