Cleansing Efficacy of Waist-shaped Interdental Brushes.

NCT ID: NCT03851757

Last Updated: 2019-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-03-02

Brief Summary

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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

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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.

Conditions

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Periodontitis, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised, controlled, examiner-blinded, two-period crossover study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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waist-shaped interdental brush

waist-shaped interdental brush, use four times per interdental space

Group Type ACTIVE_COMPARATOR

waist-shaped interdental brush

Intervention Type DEVICE

use four times each per interdental space

cylindric interdental brush

cylindric interdental brush, use four times per interdental space

Group Type ACTIVE_COMPARATOR

cylindric interdental brush

Intervention Type DEVICE

use four times each per interdental space

Interventions

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waist-shaped interdental brush

use four times each per interdental space

Intervention Type DEVICE

cylindric interdental brush

use four times each per interdental space

Intervention Type DEVICE

Other Intervention Names

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Brand name: Circum Topcaredent Brand name: Topcaredent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ines Kapferer-Seebacher, Professor

Role: PRINCIPAL_INVESTIGATOR

Medical University of Innsbruck

Locations

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Medical University of Innsbruck

Innsbruck, , Austria

Site Status

Countries

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Austria

References

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Chongcharoen N, Lulic M, Lang NP. Effectiveness of different interdental brushes on cleaning the interproximal surfaces of teeth and implants: a randomized controlled, double-blind cross-over study. Clin Oral Implants Res. 2012 May;23(5):635-40. doi: 10.1111/j.1600-0501.2011.02387.x. Epub 2011 Dec 6.

Reference Type BACKGROUND
PMID: 22146002 (View on PubMed)

Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

Reference Type BACKGROUND
PMID: 5264376 (View on PubMed)

Saxer UP, Turconi B, Elsasser C. Patient motivation with the papillary bleeding index. J Prev Dent. 1977 Jul-Aug;4(4):20-2. No abstract available.

Reference Type BACKGROUND
PMID: 351174 (View on PubMed)

Schnabl D, Goebel G, Kadletz A, Gaenzer H, Steiner R, Laimer J, Kapferer-Seebacher I. Cleansing efficacy of waist-shaped inter-dental brushes. A randomized-controlled crossover study. J Clin Periodontol. 2020 Jan;47(1):30-35. doi: 10.1111/jcpe.13210. Epub 2019 Nov 3.

Reference Type DERIVED
PMID: 31609489 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AN5123

Identifier Type: -

Identifier Source: org_study_id

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