Cleansing Efficacy of Waist-shaped Interdental Brushes.

Study Overview
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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.

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

Conditions
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Periodontitis, Adult

Intervention / Treatment
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* Device: waist-shaped interdental brush
* Device: cylindric interdental brush


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomised, controlled, examiner-blinded, two-period crossover study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: waist-shaped interdental brush<br>waist-shaped interdental brush, use four times per interdental space | Device: waist-shaped interdental brush<br>* use four times each per interdental space<br>* Other names: Brand name: Circum Topcaredent;|
| Active Comparator: cylindric interdental brush<br>cylindric interdental brush, use four times per interdental space | Device: cylindric interdental brush<br>* use four times each per interdental space<br>* Other names: Brand name: Topcaredent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biofilm, interdental brushes, interproximal, oral hygiene, periodontal disease(s)/periodontitis