Cleansing Efficacy of Waist-shaped Interdental Brushes.

NCT03851757 | Completed

• 1 other identifier: AN5123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Adult

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Turesky modification of the Quigley and Hein Plaque Index

  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 Outcomes (1)

• papillary bleeding index by Saxer and Mühlemann

  11 weeks

Study Arms (2)

waist-shaped interdental brush

ACTIVE COMPARATOR

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

Device: waist-shaped interdental brush

cylindric interdental brush

ACTIVE COMPARATOR

cylindric interdental brush, use four times per interdental space

Device: cylindric interdental brush

Interventions

waist-shaped interdental brush DEVICE

use four times each per interdental space

Also known as: Brand name: Circum Topcaredent

waist-shaped interdental brush

cylindric interdental brush DEVICE

use four times each per interdental space

Also known as: Brand name: Topcaredent

cylindric interdental brush

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

Related Publications (4)

• 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.

  PMID: 22146002 BACKGROUND

• 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.

  PMID: 5264376 BACKGROUND

• 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.

  PMID: 351174 BACKGROUND

• 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.

  PMID: 31609489 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ines Kapferer-Seebacher, Professor

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, controlled, examiner-blinded, two-period crossover study

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 22, 2019
• Study Start: September 1, 2017
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)