N/A
N=110
Effect of a Multi-directional Power Toothbrush on Recession
Gingival Recession
Bottom Line
View on ClinicalTrials.gov: NCT02530671 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Gingival Recession at Sites With Preexisting Recessions ≥2mm — 2.09; 2.08 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Toothbrushing with manual toothbrush (Device); Toothbrushing with power toothbrush (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital Schleswig-Holstein
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gingival Recession at Sites With Preexisting Recessions ≥2mm |
2.09; 2.08 | — |
| PRIMARY Bristle Splay Index (BSI) After a Specific Time-of-use |
0.2; 0.1 | — |
| SECONDARY Recession at All Buccal Sites |
0.416; 0.007 | — |
| SECONDARY Percentage of Recession Sites Demonstrating a Change of ≥1mm |
14; 24; 9; 5 | — |
| SECONDARY Pocket Probing Depths at 12months |
1.91; 1.88 | — |
| SECONDARY Comparison of BSI Between Periods |
23.6; 6.4; 28.0; 9.8 | — |
Summary
Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months
Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.
Eligibility Criteria
Inclusion Criteria
- 18 scorable teeth without orthodontic appliances or crowns and bridges
- at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth)
Exclusion Criteria
- evidence of neglected dental health
- periodontitis and/or major hard/soft tissue lesions
- any physical limitations or restrictions potentially interfering with normal oral hygiene
- therapy with any drug within 28 days prior to the study
- pregnancy or breast feeding
- any systematic condition or significant illness
Data sourced from ClinicalTrials.gov (NCT02530671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.