Overview

Systemic Probiotics in the Periodontal Treatment

Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
0
Participant gender:
All
Summary
The aim of this multicenter randomized clinical trial is to evaluate the clinical, microbiological and immunological effects of probiotics as an adjunct to Scaling and Root Planing alone or in combination with Metronidazole and Amoxicillin in the treatment of periodontitis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Belén Retamal-Valdes
Treatments:
Amoxicillin
Metronidazole
Criteria
Inclusion Criteria:

- ≥30 years of age;

- at least 15 teeth (excluding third molars and teeth with advanced decay indicated for
extraction);

- a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical
attachment level (CAL) ≥5 mm;

- at least 30% of the sites with probing depth (PD) and clinical attachment level (CAL)
≥4 mm and bleeding on probing (BOP);

Exclusion Criteria:

- pregnancy;

- breastfeeding;

- current smoking and former smoking within the past 5 years;

- systemic diseases that could affect the progression of periodontitis (e.g. diabetes,
immunological disorders, osteoporosis);

- scaling and root planing an in the previous 12 months;

- antibiotic therapy in the previous 6 months;

- long-term intake of anti-inflammatory medications;

- need for antibiotic pre-medication for routine dental therapy;

- use of orthodontic appliances;

- extensive dental prosthetic rehabilitation;

- allergy to metronidazole and/or amoxicillin.