Probiotic Intervention After Surgical Removal of Mandibular Third Molars

Not Applicable

Completed

• Conditions: Surgery--Complications; Molar, Third
• Interventions: Dietary Supplement: Probiotic AB-DENTALAC; Other: Placebo; Procedure: Surgical removal of mandibular third molars at baseline; Drug: Ibuprofen

• Registration Number: NCT04203771
• Lead Sponsor: AB Biotics, SA

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.

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic AB-DENTALAC	Orodispersible tablets containing AB-DENTALAC probiotic formula.
Probiotic	Surgical removal of mandibular third molars at baseline	Orodispersible tablets containing AB-DENTALAC probiotic formula.
Control	Placebo	Orodispersible tablets without probiotic strains (excipients only).
Control	Surgical removal of mandibular third molars at baseline	Orodispersible tablets without probiotic strains (excipients only).
Control	Ibuprofen	Orodispersible tablets without probiotic strains (excipients only).
Probiotic	Ibuprofen	Orodispersible tablets containing AB-DENTALAC probiotic formula.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital de Nens de Barcelona (Children's Hospital of Barcelona)); 🇪🇸 Barcelona, Spain