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Completed

NCT Number: NCT04203771

Probiotic Intervention After Surgical Removal of Mandibular Third Molars

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.

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Key information

Conditions

Surgery--Complications Molar, Third

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Barcelona, 08009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic AB-DENTALAC

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.

Placebo

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

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

Drug

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

Other names: Dalsy

Primary outcomes

  1. Complications derived from surgical removal of both mandibular third molars

    Time frame: 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 outcomes

  1. Post-surgical pain, patient-rated

    Time frame: 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.

  2. Post-surgical swelling, patient-rated

    Time frame: 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.

  3. Post-surgical eating difficulty, patient-rated

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AB Biotics, SA

Industry

Collaborators

  • Hospital de Nens de Barcelona

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2019
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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