Gingival RecessionNCT02951065
Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession
A study testing Tooth brush without nylon bristles and Tooth brush with soft nylon bristles in people with Gingival Recession, run by Western University of Health Sciences.
Trial summary
This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Tooth brush without nylon bristles and Tooth brush with soft nylon bristles
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to 10 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receive regular periodontal treatment at the Western University of Health Sciences Dental Center
- have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths
Who cannot join
- unable to provide consent
- had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3
- acute pain or infection
- caries near the gingival margin
- restorations covering the gingival recession defect
- presence of Miller Class III or IV defects
Show all 15Show fewer
- severe or aggressive periodontitis
- missing more than one anterior tooth
- severe malocclusion
- presence of occlusal trauma requiring more than limited adjustment
- Tobacco use
- ongoing or planned orthodontic therapy
- oral piercings
- history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits
- preferred use of an electric tooth brush over a manual brush
About this study
Official title: A Pilot Randomized Clinical Trial of a Manual Bristle-less Tooth Brush Demonstrates Slight Improvement in Gingival Recession Compared to a Conventional Soft Manual Brush
This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush.
Subjects are recruited from patients attending the Western University of Health Sciences Dental Center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. The exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.
Read the detailed description
Purpose: This randomized clinical trial tested if a novel bristle-less tooth brush design is more effective in preventing gingival recession in adults receiving periodontal maintenance than a soft tooth brush with nylon bristles.
Materials and methods: The investigators will recruit 23 subjects with gingival recession who received regular periodontal maintenance care at Western University of Health Sciences Dental Center, and who did not exhibit signs of acute dental and systemic disease, occlusal discrepancies and parafunctional habits. The investigators will randomly assign these subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group using the experimental tooth brush that contains a brush head with short, soft, rubbery cones. Both groups will receive regular maintenance and periodontal exams by blinded examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and gingival recession. In addition, gingival recession will also be determined using a measuring guide on study models obtained with polyvinylsiloxane impressions. For added control of confounding variables, both groups will be supplied with abrasivity tooth paste and waxed floss while receiving repeated oral hygiene instruction and phone follow-up.
- Conditions
- Gingival Recession
- Being tested
- Tooth brush without nylon bristles, Tooth brush with soft nylon bristles
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth brush without nylon bristlesOther
Also called PeriClean Toothbrush
Subjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
Tooth brush with soft nylon bristlesOther
Also called Oral B soft brush
Subjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
| Study group | Role | What they receive |
|---|---|---|
| Bristle-less brush | Experimental | Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily Receives: Other: Tooth brush without nylon bristles |
| Soft bristle brush | Active comparator | Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily Receives: Other: Tooth brush with soft nylon bristles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.
Measured: About 1 year
Secondary outcomes (3)
Plaque level
Oral plaque level as recorded using the Quigley-Hein index as modified by Turesky
Measured: About 1 year
Gingival bleeding on probing
% bleeding sites on probing (6 sites per tooth). Gingival bleeding is a measure of gingival inflammation, which needs to stay minimal no matter what tooth brush is used.
Measured: About 1 year
Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)
This is another measure of periodontal inflammation and sign of gum disease, as well as effectiveness of brush in preventing plaque buildup and development of periodontal disease.
Measured: About 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startMar 2015
- Primary completion15 Feb 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peri-Swab, LLC
- Responsible party
- Principal investigator, Tobias K. Boehm, DDS,PhD, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951065
- Sponsor's protocol ID
- WUCDM 1 2016
- Status last verified
- May 2017
- First submitted
- 27 Oct 2016
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Clinical Trial of a Manual Bristle-less Tooth Brush Demonstrates Slight Improvement in Gingival Recession Compared to a Conventional Soft Manual Brush
- ClinicalTrials.gov ID
- NCT02951065
- Acronym / sponsor ID
- WUCDM 1 2016
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Collaborators
- Peri-Swab, LLC
- Study start
- Mar 2015
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush.
Subjects are recruited from patients attending the Western University of Health Sciences Dental Center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. The exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.
Detailed description
Purpose: This randomized clinical trial tested if a novel bristle-less tooth brush design is more effective in preventing gingival recession in adults receiving periodontal maintenance than a soft tooth brush with nylon bristles.
Materials and methods: The investigators will recruit 23 subjects with gingival recession who received regular periodontal maintenance care at Western University of Health Sciences Dental Center, and who did not exhibit signs of acute dental and systemic disease, occlusal discrepancies and parafunctional habits. The investigators will randomly assign these subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group using the experimental tooth brush that contains a brush head with short, soft, rubbery cones. Both groups will receive regular maintenance and periodontal exams by blinded examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and gingival recession. In addition, gingival recession will also be determined using a measuring guide on study models obtained with polyvinylsiloxane impressions. For added control of confounding variables, both groups will be supplied with abrasivity tooth paste and waxed floss while receiving repeated oral hygiene instruction and phone follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bristle-less brush | Experimental | Other: Tooth brush without nylon bristlesSubjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily |
| Soft bristle brush | Active comparator | Other: Tooth brush with soft nylon bristlesSubjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- receive regular periodontal treatment at the Western University of Health Sciences Dental Center
- have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths
Key exclusion criteria (15 listed)
- unable to provide consent
- had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3
- acute pain or infection
- caries near the gingival margin
- restorations covering the gingival recession defect
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 |
|---|---|---|
| Tooth brush without nylon bristlesAlso: PeriClean ToothbrushSubjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months | Other | Bristle-less brush |
| Tooth brush with soft nylon bristlesAlso: Oral B soft brushSubjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months | Other | Soft bristle brush |
Primary outcome
Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
Time frame: About 1 year
Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.
3 secondary outcomes
Plaque level
Time frame: About 1 year
Gingival bleeding on probing
Time frame: About 1 year
Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)
Time frame: About 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: No
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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 Tooth brush without nylon bristles and Tooth brush with soft nylon bristles in people with Gingival Recession, run by Western University of Health Sciences.
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 15 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 10 May 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (Distance between cemento-enamel junction and gingival margin as measured in millimeters) (time frame: About 1 year). 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 10 May 2017.