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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Plaque; Biofilm
• Intervention / Treatment: Other: Toothbrushing

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Inmaculada Tomás Carmona, S Lecturer; Phone Number: 12384 981563100; Email: inmaculada.tomas@usc.es

Study Locations

• Spain
  • Galicia/ A Coruña
    • Santiago de Compostela, Galicia/ A Coruña, Spain, 15782
      • Recruiting
      • Univeristy of Santiago de Compostela, Faculty of Dentistry
      • Contact: Inmaculada Tomás Carmona, S Lecturer; Phone Number: 12384 981563100; Email: inmaculada.tomas@usc.es
      • Sub-Investigator: Isabel Prada, PHD student
      • Sub-Investigator: Víctor Quintas, PHD student
      • Principal Investigator: Inmaculada Tomás Camona, S Lecture

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No toothbrushing during experiment and Pyrosequencing; 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 Intervention: No toothbrushing during experiment; Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).
Active Comparator: Toothbrushing during experiment; 48hours-Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).	Other: Toothbrushing; Normal toothbrushing without toothpaste or antiseptic mouthwash.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial viability	It will be measured by analysis of images taken by Confocal laser Scanning Microscope	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.	Bacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavity

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biofilm thickness	It will be measured by analysing sectional images taken by Confocal Laser Scanning Microscope.	Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Investigators: Principal Investigator: Inmaculada Tomás Carmona, S Lecturer, Univeristy of Santiago de Compostela

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: May 8, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 8, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: pyrosequencing; 16S DNA gene; Confocal Laser Scanning Microscope; bacterial viability; bacterial diversity
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Mouth, Edentulous
• Other Study ID Numbers: Pyro-Biofilm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will shared in a supplementary file in the published paper