Cleansing Efficacy of Waist-shaped Interdental Brushes.

Periodontitis, Adult Clinical Trial

— Waist-shaped  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851757
• Other study ID #: AN5123
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 2, 2018

Study information

• Verified date: January 2019
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult

Intervention

Device:
• waist-shaped interdental brush
use four times each per interdental space
• cylindric interdental brush
use four times each per interdental space

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. — View Citation

Saxer UP, Turconi B, Elsässer C. Patient motivation with the papillary bleeding index. J Prev Dent. 1977 Jul-Aug;4(4):20-2. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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