Cleansing Efficacy of Waist-shaped Interdental Brushes. (Waist-shaped)

February 20, 2019 updated by: Medical University Innsbruck

Cleansing Efficacy of Waist-shaped Interdental Brushes. A Randomized-controlled Crossover Study.

The aim of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of waist-shaped interdental brushes with that of cylindric interdental brushes in interproximal sites.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Brushing efficacy of cylindric and waist-shaped interdental brushes was evaluated in a randomized, controlled, examiner-blinded, two-period crossover study. 20 periodontal maintenance patients of the University Hospital of Dental Prosthetics and Restorative Dentistry were recruited. Each subject was asked to attend three appointments. In the first visit (day one), baseline plaque and bleeding indices were assessed. Each proband was instructed by the same experienced dental hygienist with two sizes of waist-shaped and cylindric interdental brushes, respectively. Primary outcome measure plaque index and secondary outcome measure papillary bleeding index were assessed by two blinded and calibrated examiners at four sites per tooth.The odds ratio and confidence interval for establishing plaque free interdental sites were calculated with logistic regression analysis.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medical University of Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Periodontitis stage 3
  • Completion of active periodontal treatment
  • Maximum probing pocket depths of 5 mm
  • No site ≥ 4 mm with bleeding on probing
  • Bleeding on probing < 10%
  • Open interproximal spaces both, in mandible and maxilla
  • Presence of > 23 natural teeth with no need for prosthetic rehabilitation.

Exclusion Criteria:

  • Oral or systemic diseases other than Periodontitis
  • Mucosal / periodontal swelling or Suppuration
  • Pregnancy
  • Minority
  • Need for frequent drug consumption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: waist-shaped interdental brush
waist-shaped interdental brush, use four times per interdental space
Device: waist-shaped interdental brush
use four times each per interdental space
Other Names:
  • Brand name: Circum Topcaredent
Active Comparator: cylindric interdental brush
cylindric interdental brush, use four times per interdental space
Device: cylindric interdental brush
use four times each per interdental space
Other Names:
  • Brand name: Topcaredent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turesky modification of the Quigley and Hein Plaque Index
Time Frame: 11 weeks
This is a plaque index scored as 0 = no plaque; 1 = slight flecks of plaque at the cervical margin of the tooth; 2 = a thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3 = a band of plaque wider than 1 mm but covering < 1/3 of the crown of the tooth; 4 = plaque covering at least 1/3 but < 2/3 of the crown of the tooth or 5 = plaque covering 2/3 or more of the crown of the tooth. A higher grade is worse (more plaque) than a lower grade. After measuring plaque grades on four sites per tooh, the mode is calculated, which is defined as the plaque grade most often measured in an individual.
11 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
papillary bleeding index by Saxer and Mühlemann
Time Frame: 11 weeks
A periodontal probe is inserted into the gingival sulcus at the line angle on the mesial and distal aspect of the papilla and then moved coronally to the papilla tip (score 0 - no bleeding; score 1 - a single discreet bleeding point; score 2 - several isolated bleeding points or a single line of blood; score 3 - the interdental triangle fills with blood; score 4 - profuse bleeding occurs after probing and flows immediately into the marginal sulcus). A higher bleeding grade is worse (more inflammed tissues) than a lower grade. After measuring papillary bleeeding grades on four sites per tooh, the mode is calculated, which is defined as the papillary bleeding grade most often measured in an individual.
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Ines Kapferer-Seebacher, Professor, Medical University of Innsbruck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

March 2, 2018

Study Completion (Actual)

March 2, 2018

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN5123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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