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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth

NCT02769260

Biofilm Dental Plaque

UNKNOWN EARLY_PHASE1

Digital PCR for Quantifying Periodontal Pathobionts

NCT06692595

Periodontal Diseases

COMPLETED

Dental Biofilm Control During Orthodontic Treatment

NCT05532241

Gingivitis Malocclusion

RECRUITING PHASE3

Metronidazole as an Adjunct of Non- Surgical Treatment of Peri-implantitis

NCT03564301

Peri-Implantitis

COMPLETED PHASE4

Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis

NCT03554187

Probiotics, Periodontitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis Periodontal Bone Loss Resistance Bacterial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded, randomized clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

SCALE AND ROOT PLANING

Intervention Type PROCEDURE

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).

ADJUNTIVE ANTIBIOTICS

Intervention Type DRUG

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.

MICROBIAL SAMPLING

Intervention Type DIAGNOSTIC_TEST

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.

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.

Group Type ACTIVE_COMPARATOR

SCALE AND ROOT PLANING

Intervention Type PROCEDURE

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).

ADJUNTIVE ANTIBIOTICS

Intervention Type DRUG

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.

MICROBIAL SAMPLING

Intervention Type DIAGNOSTIC_TEST

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.

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.

Group Type ACTIVE_COMPARATOR

SCALE AND ROOT PLANING

Intervention Type PROCEDURE

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).

ADJUNTIVE ANTIBIOTICS

Intervention Type DRUG

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.

MICROBIAL SAMPLING

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type PROCEDURE

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.

Intervention Type DRUG

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No