Gingival RecessionNCT02534220
Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure
A study testing Manual Toothbrush and Oscillating-rotating toothbrush in people with Gingival Recession, run by University of Milan at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Manual Toothbrush and Oscillating-rotating toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Nov 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Full-Mouth Plaque Score (FMPS) ≤25%
- Full-Mouth Bleeding Score (FMBS) ≤25%
- Miller Class I and II buccal recession ≥2 mm
Who cannot join
- Relevant systemic condition or disease
- Smokers
- Teeth with prosthetic crowns or restorations in the cervical area
- Presence of pulling frenum in the keratinized tissue
- Previous mucogingival or periodontal surgery in the experimental site
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
Milan, MI, 20122
About this study
Official title: Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
Read the detailed description
BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
METHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test.
- Conditions
- Gingival Recession
- Being tested
- Manual Toothbrush, Oscillating-rotating toothbrush
- Keywords
- Toothbrushing, Oral hygiene, Dental hygiene
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ToothbrushDevice
Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter \& Gamble, Cincinnati, OH
Oscillating-rotating toothbrushDevice
Triumph 5000, Oral-B, Procter \& Gamble, Cincinnati, OH
| Study group | Role | What they receive |
|---|---|---|
| Manual Toothbrush | Active comparator | Patients were instructed in the Roll Brushing Technique, twice daily for 2 min. Receives: Device: Manual Toothbrush |
| Oscillating-rotating toothbrush | Experimental | Patients received manufacturer's instructions for use, including brushing twice daily for 2 min. Receives: Device: Oscillating-rotating toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Complete Root Coverage Rate
Abscence of exposed root surface measured ad percentage
Measured: Change in Complete Root Coverage Rate at 1 month
Change in Complete Root Coverage Rate
Abscence of exposed root surface measured ad percentage
Measured: Change in Complete Root Coverage Rate at 3 months
Change in Complete Root Coverage Rate
Abscence of exposed root surface measured ad percentage
Measured: Change in Complete Root Coverage Rate at 6 months
Secondary outcomes (3)
Change in Recession Depth
Distance from the gingival margin to the cementum-enamel junction, measured in millimeters
Measured: Baseline, 1 month, 3 months, 6 months
Change in Clinical Attachment Level
Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters
Measured: Baseline, 1 month, 3 months, 6 months
Change in Probing Pocket Depth
Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters
Measured: Baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Rasperini, University of Milan
- Investigators
- Giulio Rasperini, Study director, Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534220
- Sponsor's protocol ID
- Oral-B
- Status last verified
- Aug 2015
- First submitted
- 21 Aug 2015
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02534220
- Acronym / sponsor ID
- Oral-B
- Conditions
- Gingival Recession
- Keywords
- Toothbrushing, Oral hygiene, Dental hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Aug 2015 (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.
The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
Detailed description
BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
METHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Toothbrush | Active comparator | Device: Manual ToothbrushPatients were instructed in the Roll Brushing Technique, twice daily for 2 min. |
| Oscillating-rotating toothbrush | Experimental | Device: Oscillating-rotating toothbrushPatients received manufacturer's instructions for use, including brushing twice daily for 2 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Full-Mouth Plaque Score (FMPS) ≤25%
- Full-Mouth Bleeding Score (FMBS) ≤25%
- Miller Class I and II buccal recession ≥2 mm
Key exclusion criteria (5 listed)
- Relevant systemic condition or disease
- Smokers
- Teeth with prosthetic crowns or restorations in the cervical area
- Presence of pulling frenum in the keratinized tissue
- Previous mucogingival or periodontal surgery in the experimental site
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 |
|---|---|---|
| Manual ToothbrushGum Delicate Post-Surgical Toothbrush, Oral-B, Procter \& Gamble, Cincinnati, OH | Device | Manual Toothbrush |
| Oscillating-rotating toothbrushTriumph 5000, Oral-B, Procter \& Gamble, Cincinnati, OH | Device | Oscillating-rotating toothbrush |
Primary outcome
Change in Complete Root Coverage Rate
Time frame: Change in Complete Root Coverage Rate at 1 month
Abscence of exposed root surface measured ad percentage
Change in Complete Root Coverage Rate
Time frame: Change in Complete Root Coverage Rate at 3 months
Abscence of exposed root surface measured ad percentage
Change in Complete Root Coverage Rate
Time frame: Change in Complete Root Coverage Rate at 6 months
Abscence of exposed root surface measured ad percentage
3 secondary outcomes
Change in Recession Depth
Time frame: Baseline, 1 month, 3 months, 6 months
Change in Clinical Attachment Level
Time frame: Baseline, 1 month, 3 months, 6 months
Change in Probing Pocket Depth
Time frame: Baseline, 1 month, 3 months, 6 months
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 27 Aug 2015.
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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.
Giulio Rasperini study director
Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Toothbrush and Oscillating-rotating toothbrush in people with Gingival Recession, run by University of Milan at 1 site in Italy.
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 3 inclusion and 5 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 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Complete Root Coverage Rate (time frame: Change in Complete Root Coverage Rate at 1 month). The study lists 3 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 27 Aug 2015.