Probiotic Intervention After Surgical Removal of Mandibular Third Molars

Surgery--Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203771
• Other study ID #: PB-0202015-FHNB
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2020
• Source: AB Biotics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Molar, Third
• Surgery--Complications

Intervention

Dietary Supplement:
• Probiotic 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.

Other:
• Placebo
Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.

Procedure:
• Surgical 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.

Drug:
• Ibuprofen
Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days

Locations

Country	Name	City	State
Spain	Hospital de Nens de Barcelona (Children's Hospital of Barcelona))	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
AB Biotics, SA	Hospital de Nens de Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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