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Cleansing Efficacy of Waist-shaped Interdental Brushes.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03851757
Acronym
Waist-shaped
Enrollment
20
Registered
2019-02-22
Start date
2017-09-01
Completion date
2018-03-02
Last updated
2019-02-22

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

Conditions

Periodontitis, Adult

Keywords

biofilm, interdental brushes, interproximal, oral hygiene, periodontal disease(s)/periodontitis

Brief summary

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.

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.

Interventions

DEVICEwaist-shaped interdental brush

use four times each per interdental space

DEVICEcylindric interdental brush

use four times each per interdental space

Sponsors

Medical University Innsbruck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Intervention model description

Randomised, controlled, examiner-blinded, two-period crossover study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Turesky modification of the Quigley and Hein Plaque Index11 weeksThis 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

MeasureTime frameDescription
papillary bleeding index by Saxer and Mühlemann11 weeksA 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.

Countries

Austria

Outcome results

None listed

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