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

U

University of Santiago de Compostela

Status and phase

Unknown
Early Phase 1

Conditions

Dental Plaque
Biofilm

Treatments

Other: Toothbrushing

Study type

Interventional

Funder types

Other

Identifiers

NCT02769260
Pyro-Biofilm

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

15 participants in 3 patient groups

No toothbrushing during experiment and Pyrosequencing
No Intervention group
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.
No toothbrushing during experiment
No Intervention group
Description:
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 group
Description:
48hours-Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).
Treatment:
Other: Toothbrushing

Trial contacts and locations

1

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Central trial contact

Inmaculada Tomás Carmona, S Lecturer

Data sourced from clinicaltrials.gov

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