An interventional study of Toothbrushing with manual toothbrush and Toothbrushing with power toothbrush in Gingival Recession, sponsored by University Hospital Schleswig-Holstein. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-01.
Sponsored by University Hospital Schleswig-Holstein · Not applicable, Interventional, and Prevention
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.
413 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 110 is above the median of 30 across 379 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →University Hospital Schleswig-Holstein is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ADA reference manual toothbrush
Device: Toothbrushing with manual toothbrush
Multi-directional power toothbrush
Device: Toothbrushing with power toothbrush
Gingival Recession at Sites With Preexisting Recessions ≥2mm
Time frame: 12 months
Bristle Splay Index (BSI) After a Specific Time-of-use
A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).
Time frame: 3, 6, 9 and 12 months
Recession at All Buccal Sites
Time frame: 12 months
Percentage of Recession Sites Demonstrating a Change of ≥1mm
Time frame: 12 months
Pocket Probing Depths at 12months
Time frame: 12 months
Comparison of BSI Between Periods
Time frame: 0-3, 9-12 months
| Milestone | Manual Toothbrush | Power Toothbrush |
|---|---|---|
| Started | 55 | 55 |
| Completed | 52 | 55 |
| Not completed | 3 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| mm | Manual Toothbrush | Power Toothbrush |
|---|---|---|
| Gingival Recession at Sites With Preexisting Recessions ≥2mm | 2.09 ± 0.29 | 2.08 ± 0.30 |
| mm | Manual Toothbrush | Power Toothbrush |
|---|---|---|
| Recession at All Buccal Sites | 0.416 ± 0.18 | 0.007 ± 0.16 |
| percentage of sites | Manual Toothbrush | Power Toothbrush |
|---|---|---|
| decrease | 14 | 24 |
| increase | 9 | 5 |
| mm | Manual Toothbrush | Power Toothbrush |
|---|---|---|
| Pocket Probing Depths at 12months | 1.91 ± 0.17 | 1.88 ± 0.18 |
A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).
| percentage of the original bristle field | Manual Toothbrush | Power Toothbrush |
|---|---|---|
| Bristle Splay Index (BSI) After a Specific Time-of-use | 0.2 ± 0.2 | 0.1 ± 0.1 |
| percentage of the original bristle field | Manual Toothbrush | Power Toothbrush |
|---|---|---|
| 0-3 months | 23.6 ± 14 | 6.4 ± 11 |
| 9-12months | 28.0 ± 14.8 | 9.8 ± 12.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Manual Toothbrush | — | 0/55 (0%) | 0/55 (0%) |
| Power Toothbrush | — | 0/55 (0%) | 0/55 (0%) |
| Age, Continuous(years) | Manual Toothbrush | Power Toothbrush | Total |
|---|---|---|---|
| Mean | 30 ± 9.7 | 32 ± 12.5 | 31 ± 11.2 |
| Sex: Female, Male(Participants) | Manual Toothbrush | Power Toothbrush | Total |
|---|---|---|---|
| Female | 32 | 31 | 63 |
| Male | 23 | 24 | 47 |
| Region of Enrollment(participants) | Manual Toothbrush | Power Toothbrush | Total |
|---|---|---|---|
| Germany | 55 | 55 | 110 |
| Smoker (Yes/Now)(participants) | Manual Toothbrush | Power Toothbrush | Total |
|---|---|---|---|
| Yes | 7 | 7 | 14 |
| No | 48 | 48 | 96 |
| Previous used toothbrush (MT/PT)(participants) | Manual Toothbrush | Power Toothbrush | Total |
|---|---|---|---|
| Manual Toothbrush | 40 | 27 | 67 |
| Power Toothbrush | 15 | 28 | 43 |
No study locations are listed for this record.
The record gives a start of Jun 2011, a primary completion of Jun 2012 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2015, 3 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Schleswig-Holstein →