GingivitisSONIMANNCT04558606
Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up
A study testing Sonic Toothbrush and Manual Toothbrush in people with Gingivitis, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
Professional oral hygiene has become a customary procedure in everyday dentistry. Both manual and sonic brushes are part of normal oral hygiene education practice. Compared with manual toothbrushes, ergonomic instruments, such as sonic toothbrushes, can be a more practical and less demanding mean to remove biofilm and… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Sonic Toothbrush and Manual Toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2018to 23 Jan 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients affected by gingivitis is defined as bleeding on probing (BOP) > 25%.
- Healthy young patients (18-40 years)
- Patients with almost 5 teeth per quadrant
- Patients smoking less than 10 cigarettes a day
Who cannot join
- Presence of periodontitis (pocket depth - PPD > 4 mm)
- Patient with BOP and/or plaque index < 25%
- Patient with any systemic disease
- Orthodontic or prosthesis patient
- Patient with split
- Impossibility to come to the recall appointments
- Not willing to follow the agreed protocol
Trial locations and contacts
1 site in 1 country.
About this study
Professional oral hygiene has become a customary procedure in everyday dentistry. Both manual and sonic brushes are part of normal oral hygiene education practice. Compared with manual toothbrushes, ergonomic instruments, such as sonic toothbrushes, can be a more practical and less demanding mean to remove biofilm and plaque efficiently. Studies in literature investigate the efficacy of toothbrushes in plaque removal, but the investiagator's study would validate efficacy of toothbrushes post-causal therapy, towards lower plaque accumulation, and reduction in bleeding.
The objective of this study is to compare two methods (manual VS sonic) of tooth brushing in terms of impact on the gingival index and plaque index after one session of Full Mouth-Erythritol Powder Air Polishing Therapy (FM-EPAPT) in healthy patients.
Read more
The hypothesis of the present randomized controlled trial is that sonic tooth brushing accumulates less plaque (-10%) than manual tooth brushing.
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be instructed to use:
- CONTROL: manual toothbrush
- TEST: sonic toothbrush. Gingival index and plaque score will be evaluated at 2, 4, 6 weeks and 6 and 12 months.
Read the detailed description
Everyone's goal to have a healthy mouth is the removal of biofilm, plaque and calculus from the dental surface everyday. Moreover routine recalls ensure a better oral health and greater protection against caries, gingivitis and periodontitis. Regular attendance to oral hygiene sessions plays an important role but has to be accompanied by the compliance with home oral care instructions. The patients should be adequately instructed to take care of their oral health.
TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.
STUDY POPULATION: Healthy subject affected by gingivitis are included in the study. Presence of gingivitis is defined as bleeding on probing (BOP) > 25%.
PRIMARY OUTCOME: Change in Plaque Index (PI): change in 10% less of the site in test group.
SECONDARY OUTCOME:
- Change in Gingival Index (GI): change in presence or absence of bleeding after gently run on the surface of the marginal gingiva.
- Change in Recession (REC): change in gingival reduction.
- Change in Clinical Attachment Level (CAL): change in clinical attachment level.
- Conditions
- Gingivitis
- Being tested
- Sonic Toothbrush, Manual Toothbrush
- Keywords
- Oral Hygiene, Dental Care Instruction
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonic ToothbrushDevice
Sonic Toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®)
Manual ToothbrushDevice
Manual brushing (Technique Pro - GUM® Sunstar Italiana SRL)
| Study group | Role | What they receive |
|---|---|---|
| Sonic toothbrush | Experimental | * All patients receive full periodontal charting, a session of professional oral hygiene and OHI (oral hygiene instruction).
* Each patient is instructed by the hygienist in the correct use of the sonic toothbrush Receives: Device: Sonic Toothbrush |
| Manual toothbrush | Active comparator | * All patients receive full periodontal charting, a session of professional oral hygiene and OHI (oral hygiene instruction).
* Each patient is instructed by the hygienist in the correct use of the manual toothbrush Receives: Device: Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index (PI)
Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits. Change in 10% of the site in test group. 10% site modification in favor of the test group.
Measured: Baseline, 2, 4, 6 weeks and 6, 12 months
Secondary outcomes (3)
Change in Gingival Index (GI)
Change in percentage of site with bleeding after gently run on the surface of the marginal gingiva. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: Baseline, 2, 4, 6 weeks and 6, 12 months
Change in REC (Clinical Gingival Recession)
Change in mean of REC value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: Baseline 6, 12 months
Change in CAL (Clinical Attachment Level)
Change in mean of CAL value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: Baseline 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start8 Jan 2018
- Primary completion23 Jan 2019
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Model description
- Monocetric, pragmatic, single blinded, randomized clinical trial, parallel design.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Magda Mensi, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558606
- Sponsor's protocol ID
- SONIMAN
- Acronym
- SONIMAN
- Status last verified
- Jan 2019
- First submitted
- 16 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up
- ClinicalTrials.gov ID
- NCT04558606
- Acronym / sponsor ID
- SONIMAN / SONIMAN
- Conditions
- Gingivitis
- Keywords
- Oral Hygiene, Dental Care Instruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 22 Sep 2020 (actual)
- 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.
Professional oral hygiene has become a customary procedure in everyday dentistry. Both manual and sonic brushes are part of normal oral hygiene education practice. Compared with manual toothbrushes, ergonomic instruments, such as sonic toothbrushes, can be a more practical and less demanding mean to remove biofilm and plaque efficiently. Studies in literature investigate the efficacy of toothbrushes in plaque removal, but the investiagator's study would validate efficacy of toothbrushes post-causal therapy, towards lower plaque accumulation, and reduction in bleeding.
The objective of this study is to compare two methods (manual VS sonic) of tooth brushing in terms of impact on the gingival index and plaque index after one session of Full Mouth-Erythritol Powder Air Polishing Therapy (FM-EPAPT) in healthy patients.
The hypothesis of the present randomized controlled trial is that sonic tooth brushing accumulates less plaque (-10%) than manual tooth brushing.
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be instructed to use:
- CONTROL: manual toothbrush
- TEST: sonic toothbrush. Gingival index and plaque score will be evaluated at 2, 4, 6 weeks and 6 and 12 months.
Detailed description
Everyone's goal to have a healthy mouth is the removal of biofilm, plaque and calculus from the dental surface everyday. Moreover routine recalls ensure a better oral health and greater protection against caries, gingivitis and periodontitis. Regular attendance to oral hygiene sessions plays an important role but has to be accompanied by the compliance with home oral care instructions. The patients should be adequately instructed to take care of their oral health.
TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.
STUDY POPULATION: Healthy subject affected by gingivitis are included in the study. Presence of gingivitis is defined as bleeding on probing (BOP) > 25%.
PRIMARY OUTCOME: Change in Plaque Index (PI): change in 10% less of the site in test group.
SECONDARY OUTCOME:
- Change in Gingival Index (GI): change in presence or absence of bleeding after gently run on the surface of the marginal gingiva.
- Change in Recession (REC): change in gingival reduction.
- Change in Clinical Attachment Level (CAL): change in clinical attachment level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Monocetric, pragmatic, single blinded, randomized clinical trial, parallel design.
| Arm | Type | Receives |
|---|---|---|
| Sonic toothbrush | Experimental | Device: Sonic Toothbrush* All patients receive full periodontal charting, a session of professional oral hygiene and OHI (oral hygiene instruction). * Each patient is instructed by the hygienist in the correct use of the sonic toothbrush |
| Manual toothbrush | Active comparator | Device: Manual Toothbrush* All patients receive full periodontal charting, a session of professional oral hygiene and OHI (oral hygiene instruction). * Each patient is instructed by the hygienist in the correct use of the manual toothbrush |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients affected by gingivitis is defined as bleeding on probing (BOP) > 25%.
- Healthy young patients (18-40 years)
- Patients with almost 5 teeth per quadrant
- Patients smoking less than 10 cigarettes a day
Key exclusion criteria (7 listed)
- Presence of periodontitis (pocket depth - PPD > 4 mm)
- Patient with BOP and/or plaque index < 25%
- Patient with any systemic disease
- Orthodontic or prosthesis patient
- Patient with split
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 |
|---|---|---|
| Sonic ToothbrushSonic Toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®) | Device | Sonic toothbrush |
| Manual ToothbrushManual brushing (Technique Pro - GUM® Sunstar Italiana SRL) | Device | Manual toothbrush |
Primary outcome
Change in Plaque Index (PI)
Time frame: Baseline, 2, 4, 6 weeks and 6, 12 months
Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits. Change in 10% of the site in test group. 10% site modification in favor of the test group.
3 secondary outcomes
Change in Gingival Index (GI)
Time frame: Baseline, 2, 4, 6 weeks and 6, 12 months
Change in REC (Clinical Gingival Recession)
Time frame: Baseline 6, 12 months
Change in CAL (Clinical Attachment Level)
Time frame: Baseline 6, 12 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 25 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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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.
Magda Mensi principal investigator
Asst Degli Spedali Civili Di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonic Toothbrush and Manual Toothbrush in people with Gingivitis, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 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 4 inclusion and 7 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 25 Sep 2020. 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 Plaque Index (PI) (time frame: Baseline, 2, 4, 6 weeks and 6, 12 months). 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 25 Sep 2020.