Skip to main content
OpenTrials
Completed

NCT Number: NCT03851757

Cleansing Efficacy of Waist-shaped Interdental Brushes.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontitis, Adult Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Innsbruck

Innsbruck, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

waist-shaped interdental brush

Device

use four times each per interdental space

Other names: Brand name: Circum Topcaredent

cylindric interdental brush

Device

use four times each per interdental space

Other names: Brand name: Topcaredent

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: Waist-shaped

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2019
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.