BiofilmEarly Phase 1NCT02769260
Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
A Early Phase 1 study testing Toothbrushing in people with Biofilm and Dental Plaque, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Biofilm, Dental Plaque
- What is being tested?
- Toothbrushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Jun 2016
- Phase
- Early Phase 1
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy
- good oral health status
Who cannot join
- smoker or former smoker,
- presence of dental prostheses or orthodontic devices,
- antibiotic treatment or routine use of oral antiseptics in the previous 3 months,
- presence of any systemic disease that could alter the production or composition of saliva
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Univeristy of Santiago de Compostela, Faculty of Dentistry
Santiago de Compostela, Galicia/ A Coruña, 15782
Inmaculada Tomás Carmona, S Lecturer, 981563100 ext. 12384, inmaculada.tomas@usc.es
Isabel Prada, PHD student
About this study
The purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral hygiene measures may influence the development of the PL-Biofilm.
Read the detailed description
- To calculate an a priori sample size, the following statistical criteria were established: an effect size of 0.35, an alpha error of 0.05 and a statistical power of 87%. Assuming these criteria and using the repeated measures ANOVA test, a sample size of 15 subjects was required.
- Bacterial viability and thickness will be analyse by Confocal Laser Scanning Microscope and Live/Dead BackLight staining solution.
- Bacterial diversity will be analyse by Pyrosequencing the 16S DNAr gene.
- Conditions
- Biofilm, Dental Plaque
- Being tested
- Toothbrushing
- Keywords
- pyrosequencing, 16S DNA gene, Confocal Laser Scanning Microscope, bacterial viability, bacterial diversity
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothbrushingOther
Normal toothbrushing without toothpaste or antiseptic mouthwash.
| Study group | Role | What they receive |
|---|---|---|
| No toothbrushing during experiment and Pyrosequencing | No intervention | Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope) and 16S DNA pyrosequencing. |
| No toothbrushing during experiment | No intervention | Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope). |
| Toothbrushing during experiment | Active comparator | 48hours-Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope). Receives: Other: Toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial viability
It will be measured by analysis of images taken by Confocal laser Scanning Microscope
Measured: Bacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavity
Bacterial diversity
It will be measured by 16S rDNA gene pyrosequencing and posterior bioinformatic analysis.
Measured: Bacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavity
Secondary outcomes (1)
Biofilm thickness
It will be measured by analysing sectional images taken by Confocal Laser Scanning Microscope.
Measured: Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiofilmStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inmaculada Tomas, University of Santiago de Compostela
- Investigators
- Inmaculada Tomás Carmona, S Lecturer, Principal investigator, Univeristy of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769260
- Sponsor's protocol ID
- Pyro-Biofilm
- Status last verified
- May 2016
- First submitted
- 20 Apr 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will shared in a supplementary file in the published paper
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
- ClinicalTrials.gov ID
- NCT02769260
- Acronym / sponsor ID
- Pyro-Biofilm
- Conditions
- Biofilm, Dental Plaque
- Keywords
- pyrosequencing, 16S DNA gene, Confocal Laser Scanning Microscope, bacterial viability, bacterial diversity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 11 May 2016 (estimated)
- 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 purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral hygiene measures may influence the development of the PL-Biofilm.
Detailed description
- To calculate an a priori sample size, the following statistical criteria were established: an effect size of 0.35, an alpha error of 0.05 and a statistical power of 87%. Assuming these criteria and using the repeated measures ANOVA test, a sample size of 15 subjects was required.
- Bacterial viability and thickness will be analyse by Confocal Laser Scanning Microscope and Live/Dead BackLight staining solution.
- Bacterial diversity will be analyse by Pyrosequencing the 16S DNAr gene.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No toothbrushing during experiment and Pyrosequencing | No intervention | –Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope) and 16S DNA pyrosequencing. |
| No toothbrushing during experiment | No intervention | –Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope). |
| Toothbrushing during experiment | Active comparator | Other: Toothbrushing48hours-Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- systemically healthy
- good oral health status
Key exclusion criteria (4 listed)
- smoker or former smoker,
- presence of dental prostheses or orthodontic devices,
- antibiotic treatment or routine use of oral antiseptics in the previous 3 months,
- presence of any systemic disease that could alter the production or composition of saliva
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 |
|---|---|---|
| ToothbrushingNormal toothbrushing without toothpaste or antiseptic mouthwash. | Other | Toothbrushing during experiment |
Primary outcome
Bacterial viability
Time frame: Bacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavity
It will be measured by analysis of images taken by Confocal laser Scanning Microscope
Bacterial diversity
Time frame: Bacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavity
It will be measured by 16S rDNA gene pyrosequencing and posterior bioinformatic analysis.
1 secondary outcome
Biofilm thickness
Time frame: Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Individual participant dataSharing planned: Yes. Data will shared in a supplementary file in the published paper
Related trials for Biofilm
Active, not recruitingObservational study
Antibiotic Resistance Genes in Periodontitis
Periodontal Disease, Periodontitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee
Not yet recruitingPhase 2
Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
Typhoid Carrier, Typhoid Fever
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Inmaculada Tomás Carmona, S Lecturer principal investigator
Univeristy of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Toothbrushing in people with Biofilm and Dental Plaque, run by University of Santiago de Compostela 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 May 2016. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inmaculada Tomás Carmona, S Lecturer (981563100 ext. 12384, inmaculada.tomas@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial viability (time frame: Bacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavity). The study lists 2 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 11 May 2016.