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

Primary Purpose

Periodontitis, Adult

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
waist-shaped interdental brush
cylindric interdental brush
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontitis, Adult focused on measuring biofilm, interdental brushes, interproximal, oral hygiene, periodontal disease(s)/periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

waist-shaped interdental brush

cylindric interdental brush

Arm Description

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

cylindric interdental brush, use four times per interdental space

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

papillary bleeding index by Saxer and Mühlemann
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.

Full Information

First Posted
January 31, 2019
Last Updated
February 20, 2019
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT03851757
Brief Title
Cleansing Efficacy of Waist-shaped Interdental Brushes.
Acronym
Waist-shaped
Official Title
Cleansing Efficacy of Waist-shaped Interdental Brushes. A Randomized-controlled Crossover Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 2, 2018 (Actual)
Study Completion Date
March 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult
Keywords
biofilm, interdental brushes, interproximal, oral hygiene, periodontal disease(s)/periodontitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised, controlled, examiner-blinded, two-period crossover study
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
waist-shaped interdental brush
Arm Type
Active Comparator
Arm Description
waist-shaped interdental brush, use four times per interdental space
Arm Title
cylindric interdental brush
Arm Type
Active Comparator
Arm Description
cylindric interdental brush, use four times per interdental space
Intervention Type
Device
Intervention Name(s)
waist-shaped interdental brush
Other Intervention Name(s)
Brand name: Circum Topcaredent
Intervention Description
use four times each per interdental space
Intervention Type
Device
Intervention Name(s)
cylindric interdental brush
Other Intervention Name(s)
Brand name: Topcaredent
Intervention Description
use four times each per interdental space
Primary Outcome Measure Information:
Title
Turesky modification of the Quigley and Hein Plaque Index
Description
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.
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
papillary bleeding index by Saxer and Mühlemann
Description
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.
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Kapferer-Seebacher, Professor
Organizational Affiliation
Medical University of Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22146002
Citation
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.
Results Reference
background
PubMed Identifier
5264376
Citation
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.
Results Reference
background
PubMed Identifier
351174
Citation
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.
Results Reference
background
PubMed Identifier
31609489
Citation
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.
Results Reference
derived

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Cleansing Efficacy of Waist-shaped Interdental Brushes.

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