Periodontitis, Adult Clinical Trial
— Waist-shapedOfficial title:
Cleansing Efficacy of Waist-shaped Interdental Brushes. A Randomized-controlled Crossover Study.
NCT number | NCT03851757 |
Other study ID # | AN5123 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | March 2, 2018 |
Verified date | January 2019 |
Source | Medical University Innsbruck |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Innsbruck | Innsbruck |
Lead Sponsor | Collaborator |
---|---|
Medical University Innsbruck |
Austria,
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
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 |
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