Surgery--ComplicationsNCT04203771
Probiotic Intervention After Surgical Removal of Mandibular Third Molars
A study testing Probiotic AB-DENTALAC, Surgical removal of mandibular third molars at baseline and Ibuprofen in people with Surgery--Complications and Molar, Third, run by AB Biotics, SA at 1 site in Spain.
Trial summary
Single-center, double-blind, randomized trial of probiotics L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) taken twice daily for 7 days after surgical removal of both mandibular 3rd molars. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery--Complications, Molar, Third
- What is being tested?
- Probiotic AB-DENTALAC, Surgical removal of mandibular third molars at baseline and Ibuprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to May 2017
- 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 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Otherwise healthy male and female undergoing surgical removal of both third mandibular molars.
- Aged between 14 and 25 years.
- Providing informed consent if 18yr and older, or parents/guardians providing informed consent otherwise
Who cannot join
- Subjects with gingival index (GI; according to Loe and Silness. 1963) or dental plaque index (PlI; according to Silness and Loe. 1964) above 2 in the CPI Community Periodontal Index) teeth subset.
- Subjects having used probiotics or antibiotics within 30 days prior to study enrollment.
- Tobacco use
- Pregnant and breastfeeding women.
- Known allergies to ingredients in study products.
- Not willing to refrain from using mouthwashes during the study period
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de Nens de Barcelona (Children's Hospital of Barcelona))
Barcelona, 08009
About this study
Official title: Effect of Probiotic Intervention With Lactobacillus Brevis KABP052 (CECT7480) and Lactobacillus Plantarum KABP051 (CECT7481) After Surgical Removal of Mandibular Third Molars: a Randomized, Controlled, Double-blinded Trial
Single-center, double-blind, randomized trial of probiotics L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) taken twice daily for 7 days after surgical removal of both mandibular 3rd molars. Patients were assessed for surgery-derived complications in a follow-up visit 7 days after surgery, and provided daily evaluations of pain, swelling and eating difficulty in a patient diary.
Read the detailed description
This was a single-centre, prospective, double-blind, randomized, placebo-controlled, parallel-group study to evaluate whether probiotic supplementation during 1 week after surgery reduced post-surgery complications compared to placebo.
Healthy subjects of both genders aged between 14 and 25 years who required the surgical removal of both mandibular 3rd molars were recruited from the department of Oral and Maxillofacial Surgery at the Foundation of Hospital de Nens de Barcelona (Children's Hospital of Barcelona).
Patients were randomly assigned to receive probiotic tablets containing a mixture of L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) or to receive placebo, twice a day for 7 days post surgery.
Patients were assessed by trained specialists for surgery-derived complications (fever, oral alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. Patients also provided daily evaluations for pain, swelling and eating difficulties in a patient diary.
- Conditions
- Surgery--Complications, Molar, Third
- Being tested
- Probiotic AB-DENTALAC, Placebo, Surgical removal of mandibular third molars at baseline, Ibuprofen
- Keywords
- Probiotic, Molar removal surgery, Oral pain, Maxillofacial surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic AB-DENTALACDietary supplement
Orodispersible tablets containing Lactobacillus plantarum [now Lactoplantibacillus plantarum] KABP051 (CECT7481) and Lactobacillus brevis [now Levilactobacillus brevis] KABP052 (CECT7480) as active ingredients, at a minimum dose of 5x10^8 cfu each, and sorbitol (E420) and guar gum (E412) as excipients, taken b.i.d. for 7 days.
PlaceboOther
Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.
Surgical removal of mandibular third molars at baselineProcedure or surgery
Surgical removal of both mandibular third molars, performed under intravenous sedation and loco-regional anesthesia (Articaine Hydrochloride 4% with Epinephrine 1:100.000), after having undergone a professional oral cleaning.
IbuprofenDrug
Also called Dalsy
Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Orodispersible tablets containing AB-DENTALAC probiotic formula. Receives: Dietary Supplement: Probiotic AB-DENTALAC; Procedure: Surgical removal of mandibular third molars at baseline; Drug: Ibuprofen |
| Control | Placebo comparator | Orodispersible tablets without probiotic strains (excipients only). Receives: Other: Placebo; Procedure: Surgical removal of mandibular third molars at baseline; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications derived from surgical removal of both mandibular third molars
Occurrence of low grade fever (Yes/No), oral alveolitis (Yes/No) and/or trismus (Yes/No), as determined by a trained specialist
Measured: 7 days
Secondary outcomes (3)
Post-surgical pain, patient-rated
Oral pain derived from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary.
Measured: Daily, for 7 days
Post-surgical swelling, patient-rated
Mandibular swelling derived from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary.
Measured: Daily, for 7 days
Post-surgical eating difficulty, patient-rated
Eating difficulty as a result from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary.
Measured: Daily, for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study startJun 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital de Nens de Barcelona
- Responsible party
- Sponsor
- Investigators
- Eduard Ferres Padro, MD, Principal investigator, Children's Hospital of BarcelonaJordi Espadaler Mazo, PhD, Study chair, AB Biotics, SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203771
- Sponsor's protocol ID
- PB-0202015-FHNB
- Status last verified
- May 2020
- First submitted
- 17 Dec 2019
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Intervention With Lactobacillus Brevis KABP052 (CECT7480) and Lactobacillus Plantarum KABP051 (CECT7481) After Surgical Removal of Mandibular Third Molars: a Randomized, Controlled, Double-blinded Trial
- ClinicalTrials.gov ID
- NCT04203771
- Acronym / sponsor ID
- PB-0202015-FHNB
- Conditions
- Surgery--Complications, Molar, Third
- Keywords
- Probiotic, Molar removal surgery, Oral pain, Maxillofacial surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- Hospital de Nens de Barcelona
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Dec 2019 (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.
Single-center, double-blind, randomized trial of probiotics L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) taken twice daily for 7 days after surgical removal of both mandibular 3rd molars. Patients were assessed for surgery-derived complications in a follow-up visit 7 days after surgery, and provided daily evaluations of pain, swelling and eating difficulty in a patient diary.
Detailed description
This was a single-centre, prospective, double-blind, randomized, placebo-controlled, parallel-group study to evaluate whether probiotic supplementation during 1 week after surgery reduced post-surgery complications compared to placebo.
Healthy subjects of both genders aged between 14 and 25 years who required the surgical removal of both mandibular 3rd molars were recruited from the department of Oral and Maxillofacial Surgery at the Foundation of Hospital de Nens de Barcelona (Children's Hospital of Barcelona).
Patients were randomly assigned to receive probiotic tablets containing a mixture of L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) or to receive placebo, twice a day for 7 days post surgery.
Patients were assessed by trained specialists for surgery-derived complications (fever, oral alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. Patients also provided daily evaluations for pain, swelling and eating difficulties in a patient diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic AB-DENTALAC, Procedure: Surgical removal of mandibular third molars at baseline, Drug: IbuprofenOrodispersible tablets containing AB-DENTALAC probiotic formula. |
| Control | Placebo comparator | Other: Placebo, Procedure: Surgical removal of mandibular third molars at baseline, Drug: IbuprofenOrodispersible tablets without probiotic strains (excipients only). |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Otherwise healthy male and female undergoing surgical removal of both third mandibular molars.
- Aged between 14 and 25 years.
- Providing informed consent if 18yr and older, or parents/guardians providing informed consent otherwise
Key exclusion criteria (6 listed)
- Subjects with gingival index (GI; according to Loe and Silness. 1963) or dental plaque index (PlI; according to Silness and Loe. 1964) above 2 in the CPI Community Periodontal Index) teeth subset.
- Subjects having used probiotics or antibiotics within 30 days prior to study enrollment.
- Tobacco use
- Pregnant and breastfeeding women.
- Known allergies to ingredients in study products.
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 |
|---|---|---|
| Probiotic AB-DENTALACOrodispersible tablets containing Lactobacillus plantarum [now Lactoplantibacillus plantarum] KABP051 (CECT7481) and Lactobacillus brevis [now Levilactobacillus brevis] KABP052 (CECT7480) as active ingredients, at a minimum dose of 5x10^8 cfu each, and sorbitol (E420) and guar gum (E412) as excipients, taken b.i.d. for 7 days. | Dietary supplement | Probiotic |
| PlaceboOrodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days. | Other | Control |
| Surgical removal of mandibular third molars at baselineSurgical removal of both mandibular third molars, performed under intravenous sedation and loco-regional anesthesia (Articaine Hydrochloride 4% with Epinephrine 1:100.000), after having undergone a professional oral cleaning. | Procedure or surgery | Control, Probiotic |
| IbuprofenAlso: DalsyIbuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days | Drug | Control, Probiotic |
Primary outcome
Complications derived from surgical removal of both mandibular third molars
Time frame: 7 days
Occurrence of low grade fever (Yes/No), oral alveolitis (Yes/No) and/or trismus (Yes/No), as determined by a trained specialist
3 secondary outcomes
Post-surgical pain, patient-rated
Time frame: Daily, for 7 days
Post-surgical swelling, patient-rated
Time frame: Daily, for 7 days
Post-surgical eating difficulty, patient-rated
Time frame: Daily, for 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- 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.
Eduard Ferres Padro, MD principal investigator
Children's Hospital of Barcelona
Jordi Espadaler Mazo, PhD study chair
AB Biotics, SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic AB-DENTALAC, Surgical removal of mandibular third molars at baseline and Ibuprofen in people with Surgery--Complications and Molar, Third, run by AB Biotics, SA at 1 site in Spain.
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 6 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: finished, as of the sponsor's last update on 6 May 2020. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications derived from surgical removal of both mandibular third molars (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020.