Surface Roughness of a Dental Restorative Material and Biofilm Formation

In Vivo Study of the Relationship Between Surface Roughness of a Dental Restorative Material and Biofilm Formation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00256945

Enrollment

Registered

2005-11-22

Start date

2005-01-31

Completion date

2006-08-31

Last updated

2010-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Intake, Diabetic

Keywords

biofilm formation, dental plaque, surface roughness, dental restoration, dental materials

Brief summary

In this study we intend to find out the pattern of biofilm accumulation in vivo on various surface finishings. Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then prepare the surface of the sample and measure the surface roughness with a profilimeter and get the mean value in Ra units, then place the brackets on lower premolars and molars for 12 hours, remove them and examine the biofilm formed with confocal scanning microscope.

Detailed description

Several studies in the past to assess the effects of surface roughness on the amount of plaque accumulation in vitro, whereas only few performed a modern in vitro assessment of the plaque accumulation. In this study we intend to find out the pattern of biofilm accumulation in vivo on various surface finishings. Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then prepare the surface of the sample and measure the surface roughness with a profilimeter and get the mean value in Ra units, then place the brackets on lower premolars and molars for 12 hours, remove them and examine the biofilm formed with confocal scanning microscope. Statistical evaluation of pilot study determined the need to perform this research on twelve(12) candidates. It is our intention to check two materials in each candidate: composite resin and polymethylmetacrylate.

Interventions

PROCEDUREdental restorative material surface preparation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* any patient with intact buccal surfaces of lower molars and premolars

Exclusion criteria

* patients that used antibiotics in the three months prior to the experiment

Design outcomes

Primary

Measure	Time frame
confocal scanning laser microscope evaluation of biofilm formation	—

Secondary

Measure	Time frame
roughness analysis of the samples with profilometer	—

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026