Gingival Recession
Conditions
Keywords
multi-directional power toothbrush, manual toothbrush
Brief 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.
Interventions
DEVICEToothbrushing with manual toothbrush
DEVICEToothbrushing with power toothbrush
Sponsors
Procter and Gamble
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Recession at Sites With Preexisting Recessions ≥2mm | 12 months | — |
| Bristle Splay Index (BSI) After a Specific Time-of-use | 3, 6, 9 and 12 months | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Recession at All Buccal Sites | 12 months |
| Percentage of Recession Sites Demonstrating a Change of ≥1mm | 12 months |
| Pocket Probing Depths at 12months | 12 months |
| Comparison of BSI Between Periods | 0-3, 9-12 months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Manual Toothbrush ADA reference manual toothbrush
Toothbrushing with manual toothbrush | 55 |
| Power Toothbrush Multi-directional power toothbrush
Toothbrushing with power toothbrush | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Power Toothbrush | Total | Manual Toothbrush |
|---|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 12.5 | 31 years STANDARD_DEVIATION 11.2 | 30 years STANDARD_DEVIATION 9.7 |
| Previous used toothbrush (MT/PT) Manual Toothbrush | 27 participants | 67 participants | 40 participants |
| Previous used toothbrush (MT/PT) Power Toothbrush | 28 participants | 43 participants | 15 participants |
| Region of Enrollment Germany | 55 participants | 110 participants | 55 participants |
| Sex: Female, Male Female | 31 Participants | 63 Participants | 32 Participants |
| Sex: Female, Male Male | 24 Participants | 47 Participants | 23 Participants |
| Smoker (Yes/Now) No | 48 participants | 96 participants | 48 participants |
| Smoker (Yes/Now) Yes | 7 participants | 14 participants | 7 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Toothbrush | Bristle Splay Index (BSI) After a Specific Time-of-use | 0.2 percentage of the original bristle field | Standard Deviation 0.2 |
| Power Toothbrush | Bristle Splay Index (BSI) After a Specific Time-of-use | 0.1 percentage of the original bristle field | Standard Deviation 0.1 |
Primary
Gingival Recession at Sites With Preexisting Recessions ≥2mm
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Toothbrush | Gingival Recession at Sites With Preexisting Recessions ≥2mm | 2.09 mm | Standard Deviation 0.29 |
| Power Toothbrush | Gingival Recession at Sites With Preexisting Recessions ≥2mm | 2.08 mm | Standard Deviation 0.3 |
Secondary
Comparison of BSI Between Periods
Time frame: 0-3, 9-12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Toothbrush | Comparison of BSI Between Periods | 9-12months | 28.0 percentage of the original bristle field | Standard Deviation 14.8 |
| Manual Toothbrush | Comparison of BSI Between Periods | 0-3 months | 23.6 percentage of the original bristle field | Standard Deviation 14 |
| Power Toothbrush | Comparison of BSI Between Periods | 0-3 months | 6.4 percentage of the original bristle field | Standard Deviation 11 |
| Power Toothbrush | Comparison of BSI Between Periods | 9-12months | 9.8 percentage of the original bristle field | Standard Deviation 12.1 |
Secondary
Percentage of Recession Sites Demonstrating a Change of ≥1mm
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Manual Toothbrush | Percentage of Recession Sites Demonstrating a Change of ≥1mm | decrease | 14 percentage of sites |
| Manual Toothbrush | Percentage of Recession Sites Demonstrating a Change of ≥1mm | increase | 9 percentage of sites |
| Power Toothbrush | Percentage of Recession Sites Demonstrating a Change of ≥1mm | decrease | 24 percentage of sites |
| Power Toothbrush | Percentage of Recession Sites Demonstrating a Change of ≥1mm | increase | 5 percentage of sites |
Secondary
Pocket Probing Depths at 12months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Toothbrush | Pocket Probing Depths at 12months | 1.91 mm | Standard Deviation 0.17 |
| Power Toothbrush | Pocket Probing Depths at 12months | 1.88 mm | Standard Deviation 0.18 |
Secondary
Recession at All Buccal Sites
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Toothbrush | Recession at All Buccal Sites | 0.416 mm | Standard Deviation 0.18 |
| Power Toothbrush | Recession at All Buccal Sites | 0.007 mm | Standard Deviation 0.16 |