Probiotic Intervention After Surgical Removal of Mandibular Third Molars

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgery--Complications, Molar, Third

Intervention / Treatment
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* Dietary Supplement: Probiotic AB-DENTALAC
* Other: Placebo
* Procedure: Surgical removal of mandibular third molars at baseline
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Orodispersible tablets containing AB-DENTALAC probiotic formula. | Dietary Supplement: Probiotic AB-DENTALAC<br>* 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.<br>Procedure: Surgical removal of mandibular third molars at baseline<br>* 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.<br>Drug: Ibuprofen<br>* Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days<br>* Other names: Dalsy;|
| Placebo Comparator: Control<br>Orodispersible tablets without probiotic strains (excipients only). | Other: Placebo<br>* Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.<br>Procedure: Surgical removal of mandibular third molars at baseline<br>* 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.<br>Drug: Ibuprofen<br>* Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days<br>* Other names: Dalsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Daily, for 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Molar removal surgery, Oral pain, Maxillofacial surgery