Chronic PeriodontitisPhase 4NCT03863249
Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection.
A Phase 4 study testing SCALE AND ROOT PLANING, ADJUNTIVE ANTIBIOTICS and MICROBIAL SAMPLING in people with Chronic Periodontitis and Periodontal Bone Loss, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Periodontitis, Periodontal Bone Loss, Resistance Bacterial
- What is being tested?
- SCALE AND ROOT PLANING, ADJUNTIVE ANTIBIOTICS and MICROBIAL SAMPLING
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2019to 30 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Medications that could influence the outcome of periodontal therapy.
- Any known allergies to the test antimicrobial agents.
- Diabetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection: Randomized Clinical Trial.
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.
Read the 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.
- Being tested
- SCALE AND ROOT PLANING, ADJUNTIVE ANTIBIOTICS, MICROBIAL SAMPLING
- Keywords
- Periodontitis, Microbiome, Dysbiosis, Homeostasis, Dental plaque, Antibiotics
- Medical subject headings
- Chronic Periodontitis, Alveolar Bone Loss, Periodontitis, Dysbiosis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCALE AND ROOT PLANINGProcedure or surgery
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 ANTIBIOTICSDrug
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 SAMPLINGDiagnostic test
- 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.
- The subgingival microbiota will be harvested from the sampling sites 2 months after the completion of active therapy.
| Study group | Role | What they receive |
|---|---|---|
| The exCELLigence system | Active comparator | 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. Receives: Procedure: SCALE AND ROOT PLANING; Drug: ADJUNTIVE ANTIBIOTICS; Diagnostic Test: MICROBIAL SAMPLING |
| Origen | Active comparator | 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. Receives: Procedure: SCALE AND ROOT PLANING; Drug: ADJUNTIVE ANTIBIOTICS; Diagnostic Test: MICROBIAL SAMPLING |
| Echevarne | Active comparator | 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. Receives: Procedure: SCALE AND ROOT PLANING; Drug: ADJUNTIVE ANTIBIOTICS; Diagnostic Test: MICROBIAL SAMPLING |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start8 Feb 2019
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Superior de Investigación en Salud Publica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Responsible party
- Principal investigator, Andres Lopez Roldan, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863249
- Sponsor's protocol ID
- UV4
- Status last verified
- May 2026
- First submitted
- 25 Feb 2019
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03863249
- Acronym / sponsor ID
- UV4
- Keywords
- Periodontitis, Microbiome, Dysbiosis, Homeostasis, Dental plaque, Antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Centro Superior de Investigación en Salud Publica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Double blinded, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| The exCELLigence system | Active comparator | Procedure: SCALE AND ROOT PLANING, Drug: ADJUNTIVE ANTIBIOTICS, Diagnostic Test: MICROBIAL SAMPLING1. 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 comparator | Procedure: SCALE AND ROOT PLANING, Drug: ADJUNTIVE ANTIBIOTICS, Diagnostic Test: MICROBIAL SAMPLING1. 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 comparator | Procedure: SCALE AND ROOT PLANING, Drug: ADJUNTIVE ANTIBIOTICS, Diagnostic Test: MICROBIAL SAMPLING1. 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCALE AND ROOT PLANINGSRP 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). | Procedure or surgery | Echevarne, Origen, The exCELLigence system |
| ADJUNTIVE ANTIBIOTICSThe 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. | Drug | Echevarne, Origen, The exCELLigence system |
| MICROBIAL SAMPLING1. 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. | Diagnostic test | Echevarne, Origen, The exCELLigence system |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SCALE AND ROOT PLANING, ADJUNTIVE ANTIBIOTICS and MICROBIAL SAMPLING in people with Chronic Periodontitis and Periodontal Bone Loss, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical measure: Clinical attachment loss (CAL) change (time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.