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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02769260
Enrollment
15
Registered
2016-05-11
Start date
2015-09-30
Completion date
2016-06-30
Last updated
2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biofilm, Dental Plaque

Keywords

pyrosequencing, 16S DNA gene, Confocal Laser Scanning Microscope, bacterial viability, bacterial diversity

Brief 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. 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.

Interventions

OTHERToothbrushing

Normal toothbrushing without toothpaste or antiseptic mouthwash.

Sponsors

University of Santiago de Compostela
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* systemically healthy * good oral health status

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Bacterial viabilityBacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavityIt will be measured by analysis of images taken by Confocal laser Scanning Microscope
Bacterial diversityBacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavityIt will be measured by 16S rDNA gene pyrosequencing and posterior bioinformatic analysis.

Secondary

MeasureTime frameDescription
Biofilm thicknessOral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavityIt will be measured by analysing sectional images taken by Confocal Laser Scanning Microscope.

Countries

Spain

Contacts

Primary ContactInmaculada Tomás Carmona, S Lecturer
inmaculada.tomas@usc.es981563100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026