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

Primary Purpose

Biofilm, Dental Plaque

Status
Unknown status
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Toothbrushing
Sponsored by
University of Santiago de Compostela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Biofilm focused on measuring pyrosequencing, 16S DNA gene, Confocal Laser Scanning Microscope, bacterial viability, bacterial diversity

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Univeristy of Santiago de Compostela, Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Active Comparator

Arm Label

No toothbrushing during experiment and Pyrosequencing

No toothbrushing during experiment

Toothbrushing during experiment

Arm Description

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.

Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).

48hours-Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).

Outcomes

Primary Outcome Measures

Bacterial viability
It will be measured by analysis of images taken by Confocal laser Scanning Microscope
Bacterial diversity
It will be measured by 16S rDNA gene pyrosequencing and posterior bioinformatic analysis.

Secondary Outcome Measures

Biofilm thickness
It will be measured by analysing sectional images taken by Confocal Laser Scanning Microscope.

Full Information

First Posted
April 20, 2016
Last Updated
May 8, 2016
Sponsor
University of Santiago de Compostela
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1. Study Identification

Unique Protocol Identification Number
NCT02769260
Brief Title
Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
Official Title
Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biofilm, Dental Plaque
Keywords
pyrosequencing, 16S DNA gene, Confocal Laser Scanning Microscope, bacterial viability, bacterial diversity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No toothbrushing during experiment and Pyrosequencing
Arm Type
No Intervention
Arm Description
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.
Arm Title
No toothbrushing during experiment
Arm Type
No Intervention
Arm Description
Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).
Arm Title
Toothbrushing during experiment
Arm Type
Active Comparator
Arm Description
48hours-Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).
Intervention Type
Other
Intervention Name(s)
Toothbrushing
Intervention Description
Normal toothbrushing without toothpaste or antiseptic mouthwash.
Primary Outcome Measure Information:
Title
Bacterial viability
Description
It will be measured by analysis of images taken by Confocal laser Scanning Microscope
Time Frame
Bacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavity
Title
Bacterial diversity
Description
It will be measured by 16S rDNA gene pyrosequencing and posterior bioinformatic analysis.
Time Frame
Bacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavity
Secondary Outcome Measure Information:
Title
Biofilm thickness
Description
It will be measured by analysing sectional images taken by Confocal Laser Scanning Microscope.
Time Frame
Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inmaculada Tomás Carmona, S Lecturer
Phone
981563100
Ext
12384
Email
inmaculada.tomas@usc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inmaculada Tomás Carmona, S Lecturer
Organizational Affiliation
Univeristy of Santiago de Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Santiago de Compostela, Faculty of Dentistry
City
Santiago de Compostela
State/Province
Galicia/ A Coruña
ZIP/Postal Code
15782
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inmaculada Tomás Carmona, S Lecturer
Phone
981563100
Ext
12384
Email
inmaculada.tomas@usc.es
First Name & Middle Initial & Last Name & Degree
Isabel Prada, PHD student
First Name & Middle Initial & Last Name & Degree
Víctor Quintas, PHD student
First Name & Middle Initial & Last Name & Degree
Inmaculada Tomás Camona, S Lecture

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will shared in a supplementary file in the published paper

Learn more about this trial

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

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