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

NCT02769260 | Unknown Early Phase 1

• 1 other identifier: Pyro-Biofilm
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Biofilm; Dental Plaque

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Biofilm thickness

  Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity

Study Arms (3)

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).

Other: Toothbrushing

Interventions

Toothbrushing OTHER

Normal toothbrushing without toothpaste or antiseptic mouthwash.

Toothbrushing during experiment

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• systemically healthy
• good oral health status

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Univeristy of Santiago de Compostela, Faculty of Dentistry

Santiago de Compostela, Galicia/ A Coruña, 15782, Spain

RECRUITING

MeSH Terms

Conditions

Dental Plaque

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Officials

• Inmaculada Tomás Carmona, S Lecturer

  Univeristy of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inmaculada Tomás Carmona, S Lecturer

CONTACT

981563100; inmaculada.tomas@usc.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecture

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: May 11, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)