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

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ClinicalTrials.gov Identifier: NCT03863249
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Centro Superior de Investigación en Salud Publica
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Information provided by (Responsible Party):
Andres Lopez Roldan, University of Valencia

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Periodontal Bone Loss Resistance Bacterial Procedure: SCALE AND ROOT PLANING Drug: ADJUNTIVE ANTIBIOTICS Diagnostic Test: MICROBIAL SAMPLING Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded, randomized clinical trial.
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection: Randomized Clinical Trial.
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: The exCELLigence system
  1. 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.
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.

Active Comparator: Origen
  1. 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.
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.

Active Comparator: Echevarne
  1. 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.
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.




Primary Outcome Measures :
  1. Clinical measure: Clinical attachment loss (CAL) change [ Time Frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing). ]
    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.

  2. Clinical measure: Probing pocket depth (PPD) change [ Time Frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing). ]
    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.

  3. Clinical measure: Bleeding on probing (BOP) change, Gingival Bleeding Index. [ Time Frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing). ]
    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.

  4. O`leary plaque index change [ Time Frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing). ]
    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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863249


Contacts
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Contact: ANDRÉS LÓPEZ ROLDÁN, DOCTOR 963983136 andres.lopez-roldan@uv.es
Contact: MARTA REGLERO SANTAOLAYA 963983136 reglero@alumni.uv.es

Locations
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Spain
Marta Reglero Santaolaya Recruiting
Valencia, Spain, 46010
Contact: MARTA REGLERO    963983136    MARTAX_RS@HOTMAIL.COM   
Sponsors and Collaborators
University of Valencia
Centro Superior de Investigación en Salud Publica
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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Responsible Party: Andres Lopez Roldan, Associate professor, University of Valencia
ClinicalTrials.gov Identifier: NCT03863249     History of Changes
Other Study ID Numbers: UV4
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andres Lopez Roldan, University of Valencia:
Periodontitis
Microbiome
Dysbiosis
Homeostasis
Dental plaque
Antibiotics

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Alveolar Bone Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents