Clinical trial NCT03863249: Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection.
Official title: Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Periodontitis
Periodontal Bone Loss
Resistance Bacterial
Keywords: Periodontitis
Microbiome
Dysbiosis
Homeostasis
Dental plaque
Antibiotics
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Centro Superior de Investigación en Salud Publica
name: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
First posted: 2019-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to develop an in vitro model of growth of oral biofilms, and validate xCELLigence system for the selection of an effective antibiotic treatment for each patient.

Detailed description: Periodontitis in a chronic disease caused by bacteria present in the subgingival flora, which induces an inflammatory response of periodontal tissues. It has been suggested that some periodontal pathogens may be inaccessible to mechanical periodontal therapy due to its ability to invade the gingival tissues and evade defense mechanisms of the host. Therefore, it is conceivable that coadjuvant administration of antimicrobials may improve the outcome of mechanical therapy. There are several techniques to monitor periodontal pathogens and determine antibiotic therapy. But the most important disadvantage of conventional laboratory methods is that they are indirect, based on the molecular detection of 3 to 10 bacterial species, without analyzing whether the biofilm as a whole is sensitive or resistant to treatment, being a possible cause of failure and / or recurrence of the disease, in addition to the risk of development of antimicrobial resistance.

The investigators hypothesis is that the specific selection of antimicrobial treatment with the xCELLigence system allows better improvements in clinical parameters than indirect laboratory methods.

Materials and methods:

A randomized double-blind clinical trial will be launched. Samples of subgingival plaque will be taken with paper tips. Subjects included in the study will be randomized to one of 3 treatment groups: scaling and root planing combined with systemically administration of antibiotic suggested by the xCELLigence system; scaling and root planing combined with systemically administration of antibiotic suggested by 'Echevarne' laboratory and scaling and root planing combined with systemically administration of antibiotic suggested by 'Origen' laboratory.

Eligibility criteria: Inclusion Criteria:

1. Subjects of 40-70 years.
2. No smokers or smokers of less than 10 cigarettes a day.
3. Patients with periodontitis stages III and IV grades A-B.
4. Presence of 20 natural teeth, including at least three molar teeth.
5. Presence of at least 4 sites with at least 6 mm probing depth.
6. Good general health

Exclusion Criteria:

1. Smokers of more than 10 cigarettes a day.
2. Patients who have received periodontal treatment in the previous 12 months.
3. Patients who have used antibiotics in the last 6 months.
4. Routine use of oral antiseptics and / or during the previous 3 months.
5. Systemic conditions that required antibiotic premedication.
6. Women pregnant or nursing.
7. Medications that could influence the outcome of periodontal therapy.
8. Any known allergies to the test antimicrobial agents.
9. Diabetics.

Primary outcomes:
measure: Clinical measure: Clinical attachment loss (CAL) change
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
measure: Clinical measure: Probing pocket depth (PPD) change
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
measure: Clinical measure: Bleeding on probing (BOP) change, Gingival Bleeding Index.
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
measure: O'leary plaque index change
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Marta Reglero Santaolaya
Study officials:
References: