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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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).
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.
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.
Marta Reglero Santaolaya
Valencia, Spain
RECRUITINGClinical measure: Clinical attachment loss (CAL) change
It is defined as the distance in millimeters between CEJ and the end of the periodontal pocket. The calculation of the depth of the pocket + gingival recession or pocket depth - gingival hyperplasia will be carried out.
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
Clinical measure: Probing pocket depth (PPD) change
The probing depth will be measured in six areas (disto-buccal, mediate-vestibular, mesio-buccal, disto-palatal, mid-palatal, and mesio-palatal) of each tooth with Williams PQ-OW 208 396 probe. It will be use with a pressure of 20 grams that is equivalent to the pressure of dropping the weight of the probe without exerting additional pressure.
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
Clinical measure: Bleeding on probing (BOP) change, Gingival Bleeding Index.
The "Full mouth bleeding score" (FMBS) will be calculated based on scores of 0 (no bleeding) or 1 (bleeding) after probing depths are checked. Four surfaces per tooth are evaluated: mesial, distal, vestibular and lingual.
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
O'leary plaque index change
The percentage of gingival surfaces with presence of plaque in the dentogingival junction of the teeth is found. Four surfaces per tooth are evaluated: mesial, distal, vestibular and lingual.
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.