Back to results

Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface.

Primary Purpose

the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel Characteristic

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

brushing force

About this trial

This is an interventional treatment trial for the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel Characteristic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

extracted bovine incisors

Exclusion Criteria:

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

brushing force

Arm Description

Outcomes

Primary Outcome Measures

optimum force

The toothbrush holder was adjusted allowing toothbrush bristle to press onto the tooth surface until the loading monitor indicated the designated vertical loading force. Loading force was applied from a minimum of 1 N, with an increment of 1 N to a maximum of 6 N. The optimum force which remove all dental plaque from tooth surface will recorded.

Secondary Outcome Measures

Full Information

NCT ID

NCT04675736

First Posted

September 2, 2020

Last Updated

December 17, 2020

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT04675736

Brief Title

Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface.

Official Title

Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface: An in Vitro Study.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Objective To determine the optimum brushing force for dental plaque removal. To investigate the effect of brushing force on enamel characteristic. Hypothesis H0 : Structural tooth loss is not significantly different between before and after brushing with excessive force on enamel surface. H1 : Structural tooth loss is significantly different between before and after brushing with excessive force on enamel surface. Study design: Experimental study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel Characteristic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

brushing force

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

brushing force

Intervention Description

Using duplication method, vertical force was applied from 1-5.5 N in linear mesial-distal brushing motion at 4 strokes per second for 5 seconds Force was increase 0.5 N in every testing until plaque was completely removed from enamel surface

Primary Outcome Measure Information:

Title

optimum force

Description

Time Frame

5 seconds

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: extracted bovine incisors Exclusion Criteria: no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kanyawat rattanasuwan

Organizational Affiliation

Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University, Bangkok Thailand

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface.

We'll reach out to this number within 24 hrs