Probiotic Intervention After Surgical Removal of Mandibular Third Molars

NCT ID: NCT04203771

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-05-31

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.

Conditions

Surgery--Complications; Molar, Third

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

Orodispersible tablets containing AB-DENTALAC probiotic formula.

Group Type: EXPERIMENTAL

Probiotic AB-DENTALAC

Intervention Type: DIETARY_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.

Surgical removal of mandibular third molars at baseline

Intervention Type: PROCEDURE

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.

Ibuprofen

Intervention Type: DRUG

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

Control

Orodispersible tablets without probiotic strains (excipients only).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Surgical removal of mandibular third molars at baseline

Intervention Type: PROCEDURE

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.

Ibuprofen

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Ibuprofen

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

Intervention Type: DRUG

Other Intervention Names

Dalsy

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Nens de Barcelona

OTHER

Sponsor Role: collaborator

AB Biotics, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduard Ferres Padro, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Barcelona

Jordi Espadaler Mazo, PhD

Role: STUDY_CHAIR

AB Biotics, SA

Locations

Hospital de Nens de Barcelona (Children's Hospital of Barcelona))

Barcelona, , Spain

Countries

Spain

Other Identifiers

PB-0202015-FHNB

Identifier Type: -

Identifier Source: org_study_id