Probiotic Intervention After Surgical Removal of Mandibular Third Molars

AB Biotics

Status: Completed

Conditions: Surgery--Complications; Molar, Third

Treatments: Other: Placebo; Dietary Supplement: Probiotic AB-DENTALAC; Procedure: Surgical removal of mandibular third molars at baseline; Drug: Ibuprofen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04203771

PB-0202015-FHNB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 14 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

38 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Orodispersible tablets containing AB-DENTALAC probiotic formula.

Treatment:

Drug: Ibuprofen

Procedure: Surgical removal of mandibular third molars at baseline

Dietary Supplement: Probiotic AB-DENTALAC

Control

Placebo Comparator group

Description:

Orodispersible tablets without probiotic strains (excipients only).

Treatment:

Drug: Ibuprofen

Procedure: Surgical removal of mandibular third molars at baseline

Other: Placebo