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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva

NCT06437262

Healthy Saliva Biofilms

COMPLETED PHASE1

Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation

NCT02656251

Dental Plaque

COMPLETED PHASE3

Bacterial Arrangement on the Teeth

NCT01712672

Dental Plaque Oral Health Periodontal Disease and Caries +1 more

COMPLETED

Methodology Antiseptic Application, Influence on Oral Biofilm.

NCT02267239

Oral Biofilm Periodontitis Gingivitis

UNKNOWN PHASE4

Study of the Composition of Dental Plaque

NCT00001726

Dental Caries Dental Plaque Periodontal Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biofilm Dental Plaque

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Toothbrushing during experiment

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

Group Type ACTIVE_COMPARATOR

Toothbrushing

Intervention Type OTHER

Normal toothbrushing without toothpaste or antiseptic mouthwash.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Toothbrushing

Normal toothbrushing without toothpaste or antiseptic mouthwash.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes