Clinical trial NCT03851757: Cleansing Efficacy of Waist-shaped Interdental Brushes.
Official title: Cleansing Efficacy of Waist-shaped Interdental Brushes. A Randomized-controlled Crossover Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis, Adult
Keywords: biofilm
interdental brushes
interproximal
oral hygiene
periodontal disease(s)/periodontitis
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, controlled, examiner-blinded, two-period crossover study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Turesky modification of the Quigley and Hein Plaque Index
timeFrame: 11 weeks
Secondary outcomes:
measure: papillary bleeding index by Saxer and Mühlemann
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
Study officials:
affiliation: Medical University of Innsbruck
name: Ines Kapferer-Seebacher, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.