Molar, Third, Surgery--Complications
Conditions
Keywords
Probiotic, Molar removal surgery, Oral pain, Maxillofacial surgery
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTProbiotic AB-DENTALAC
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.
OTHERPlacebo
Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.
PROCEDURESurgical removal of mandibular third molars at baseline
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.
DRUGIbuprofen
Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days
Sponsors
Hospital de Nens de Barcelona
AB Biotics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Probiotic and placebo tablets with identical appearance were provided in anonymous packages to the investigators, solely labelled with the volunteer's randomization number
Eligibility
Sex/Gender
ALL
Age
14 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications derived from surgical removal of both mandibular third molars | 7 days | Occurrence of low grade fever (Yes/No), oral alveolitis (Yes/No) and/or trismus (Yes/No), as determined by a trained specialist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical pain, patient-rated | Daily, for 7 days | Oral pain derived from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary. |
| Post-surgical swelling, patient-rated | Daily, for 7 days | Mandibular swelling derived from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary. |
| Post-surgical eating difficulty, patient-rated | Daily, for 7 days | Eating difficulty as a result from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary. |
Countries
Spain
Outcome results
None listed