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COMPLETED
NCT03863249
PHASE4

Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection.

Sponsor: University of Valencia

View on ClinicalTrials.gov

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.

Official title: Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection: Randomized Clinical Trial.

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2019-02-08

Completion Date

2022-05-30

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

PROCEDURE

SCALE AND ROOT PLANING

SRP will be performed two quadrants at a time under local anaesthesia at approximately weekly intervals. Each session will be carried out with the following materials: - Ultrasound device (SONICflex 2003 / L) and curettes (Hu-Friedy Manufacturing, Illinois, USA).

DRUG

ADJUNTIVE ANTIBIOTICS

The antimicrobial adjunctive agents selected by 'Echevarne' laboratories analysis will be started at the second SRP visit. The antibiotic will be selected among AMOXICILIN, METRONIDAZOLE, AMOXICILIN + METRONIDAZOLE AND AZITROMYCIN.

DIAGNOSTIC_TEST

MICROBIAL SAMPLING

1. Before treatment, the 10 deepest interproximal sites in each quadrant will be selected and exposed to microbial sampling. Two sterilized paper points will be inserted into the pocket of each site and will be keep in place for 60 s. The twin paper points will be remove and distributed in two vials and transfer for microbiological processing. 2. The subgingival microbiota will be harvested from the sampling sites 2 months after the completion of active therapy.

Locations (1)

Marta Reglero Santaolaya

Valencia, Valencia, Spain