Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2019
CompletedFirst Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 5, 2019
March 1, 2019
6 months
February 25, 2019
March 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Clinical 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.
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.
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.
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.
1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
Study Arms (3)
The exCELLigence system
ACTIVE COMPARATOR1. Following the baseline examination each of the 20 randomly selected patients will be informed about the cause of periodontal disease. 2. 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. 3. The study participants will undergo SCALE AND ROOT PLANING (SRP). SRP will be performed two quadrants at a time under local anaesthesia at approximately weekly intervals. 4. The adjunctive antibiotics selected by 'the exCELLingence' system will be started at the second SRP visit.
Origen
ACTIVE COMPARATOR1. Following the baseline examination each of the 20 randomly selected patients will be informed about the cause of periodontal disease. 2. 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. 3. The study participants will undergo SCALE AND ROOT PLANING (SRP). SRP will be performed two quadrants at a time under local anaesthesia at approximately weekly intervals. 4. The adjunctive antibiotics agents selected by 'Origen' laboratories analysis will be started at the second SRP visit.
Echevarne
ACTIVE COMPARATOR1. Following the baseline examination each of the 20 randomly selected patients will be informed about the cause of periodontal disease. 2. 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. 3. The study participants will undergo SCALE AND ROOT PLANING (SRP). SRP will be performed two quadrants at a time under local anaesthesia at approximately weekly intervals. 4. The adjunctive antibiotics agents selected by 'Echevarne' laboratories analysis will be started at the second SRP visit.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subjects of 40-70 years.
- No smokers or smokers of less than 10 cigarettes a day.
- Patients with periodontitis stages III and IV grades A-B.
- Presence of 20 natural teeth, including at least three molar teeth.
- Presence of at least 4 sites with at least 6 mm probing depth.
- Good general health
You may not qualify if:
- Smokers of more than 10 cigarettes a day.
- Patients who have received periodontal treatment in the previous 12 months.
- Patients who have used antibiotics in the last 6 months.
- Routine use of oral antiseptics and / or during the previous 3 months.
- Systemic conditions that required antibiotic premedication.
- Women pregnant or nursing.
- Medications that could influence the outcome of periodontal therapy.
- Any known allergies to the test antimicrobial agents.
- Diabetics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marta Reglero Santaolaya
Valencia, 46010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Double-blinding: The researchers who performed the measurements and treatment will be different from those who performed the microbial analysis; the examiner will be blinded during the entire duration of the study about the type of analysis subgingival dental plaque has been undergone.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
February 25, 2019
First Posted
March 5, 2019
Study Start
February 8, 2019
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
March 5, 2019
Record last verified: 2019-03