Gingival RecessionNCT02530671
Effect of a Multi-directional Power Toothbrush on Recession
A study testing Toothbrushing with manual toothbrush and Toothbrushing with power toothbrush in people with Gingival Recession, run by University Hospital Schleswig-Holstein.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Toothbrushing with manual toothbrush and Toothbrushing with power toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Effect of a Multi-directional Power and a Manual Toothbrush in Subjects Susceptible to Gingival Recession: A 12-month Randomized Controlled Clinical Study
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.
- Conditions
- Gingival Recession
- Being tested
- Toothbrushing with manual toothbrush, Toothbrushing with power toothbrush
- Keywords
- multi-directional power toothbrush, manual toothbrush
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothbrushing with manual toothbrushDevice
Toothbrushing with power toothbrushDevice
| Study group | Role | What they receive |
|---|---|---|
| Manual toothbrush | Active comparator | ADA reference manual toothbrush Receives: Device: Toothbrushing with manual toothbrush |
| Power toothbrush | Experimental | Multi-directional power toothbrush Receives: Device: Toothbrushing with power toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Recession at Sites With Preexisting Recessions ≥2mm
Measured: 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).
Measured: 3, 6, 9 and 12 months
Secondary outcomes (4)
Recession at All Buccal Sites
Measured: 12 months
Percentage of Recession Sites Demonstrating a Change of ≥1mm
Measured: 12 months
Pocket Probing Depths at 12months
Measured: 12 months
Comparison of BSI Between Periods
Measured: 0-3, 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Principal investigator, Sonja Sälzer, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530671
- Sponsor's protocol ID
- 2011015
- Status last verified
- Dec 2024
- First submitted
- 18 Aug 2015
- Last updated
- 1 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multi-directional Power and a Manual Toothbrush in Subjects Susceptible to Gingival Recession: A 12-month Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02530671
- Acronym / sponsor ID
- 2011015
- Conditions
- Gingival Recession
- Keywords
- multi-directional power toothbrush, manual toothbrush
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Posted 19 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual toothbrush | Active comparator | Device: Toothbrushing with manual toothbrushADA reference manual toothbrush |
| Power toothbrush | Experimental | Device: Toothbrushing with power toothbrushMulti-directional power toothbrush |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothbrushing with manual toothbrush | Device | Manual toothbrush |
| Toothbrushing with power toothbrush | Device | Power toothbrush |
Primary outcome
Gingival Recession at Sites With Preexisting Recessions ≥2mm
Time frame: 12 months
Bristle Splay Index (BSI) After a Specific Time-of-use
Time frame: 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).
4 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrushing with manual toothbrush and Toothbrushing with power toothbrush in people with Gingival Recession, run by University Hospital Schleswig-Holstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Recession at Sites With Preexisting Recessions ≥2mm (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.