Cleansing Efficacy of Waist-shaped Interdental Brushes.

Not Applicable

Completed

• Conditions: Periodontitis, Adult
• Interventions: Device: cylindric interdental brush; Device: waist-shaped interdental brush

• Registration Number: NCT03851757
• Lead Sponsor: Medical University Innsbruck

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-02
• Status Verified: 2019-01
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Study First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cylindric interdental brush	cylindric interdental brush	cylindric interdental brush, use four times per interdental space
waist-shaped interdental brush	waist-shaped interdental brush	waist-shaped interdental brush, use four times per interdental space

Primary Outcome Measures

Name	Time	Method
Turesky modification of the Quigley and Hein Plaque Index	11 weeks	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

Name	Time	Method
papillary bleeding index by Saxer and Mühlemann	11 weeks	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.

Trial Locations

Locations (1)

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria