Gingival AbrasionASTANCT05375227
Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue
A study testing Teeth brushing in people with Gingival Abrasion, run by Philips France Commercial at 1 site in France.
Trial summary
This is a randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study. It aims to assess gingival abrasion by the comparison of pre- to- post-brushing after a single brushing and after 12 weeks of daily home brushing using a macro-relief scoring based on photographs of the gingiva. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Abrasion
- What is being tested?
- Teeth brushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 1 Apr 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dentate males and females must be at least 18 years and not more than 75 years of age
- Patient able to understand and sign the informed consent prior to starting the study
- Patient with a minimum of 3 teeth in each of the 4 quadrants and no/or pockets >4 mm
- Ability and willingness to comply with all study requirements.
Who cannot join
- Pregnancy
- Patient with cervical restorations
- Current smoker
- Patient with orthodontic banding
- Patient with oral lesions or periodontal diseases
- Patient who has been deprived of his/her freedom by administrative or legal decision or who is under trusteeship/guardianship
Show all 11Show fewer
- Patient already using an electric toothbrush
- Patient with conditions or circumstances, which may prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability;
- Patient with non-plaque induced gingival diseases or localized gingival ulceration
- Thin gingival phenotype
- Patients with cardiac pacemakers to prevent any interference between the power toothbrush and the implantable cardiac device.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study. It aims to assess gingival abrasion by the comparison of pre- to- post-brushing after a single brushing and after 12 weeks of daily home brushing using a macro-relief scoring based on photographs of the gingiva. The study also aims to assess plaque removal, gingival inflammation, gingival recession and gingival color after 12 weeks. To enter the study, adult male and female subjects attending the service of odontology at Rothschild hospital (Paris, France) will refrain from all oral hygiene procedures for 24 hours. Subjects will have the study procedure explained to them both orally and by written instructions. Eligible patients will give their written consent to participate before being included into the study. Following a baseline clinical examination for collection of the following periodontal parameters: plaque control record (PCR), bleeding on probing (BOP), gingival recession (REC), and probing pocket depths (PD), the subjects will be randomized into two balanced groups, test group assigned to the Sonicare ProtectiveClean® HX6848/92 with C2 Optimal Plaque Defense head HX9022/10 (electric toothbrush) and control group assigned to the Pierre Fabre Inava 20/100, a reference manual toothbrush. Subjects will be instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) with a low level of abrasion to minimize bias due to toothpaste abrasivity. After brushing, they will again be evaluated for primary and secondary outcomes (post-brushing). Subjects will be dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects will be instructed to brush for two minutes during each tooth brushing. The subjects will report to the study site after 12 weeks of product use, at which time they will be re-evaluated for gingival abrasion, as well as for plaque removal, gingival inflammation, gingival recession and gingival color. Data (photographs and clinical measurements) will be collected, i.e. primary and secondary variables of each patient, by blinded examiners.
- Conditions
- Gingival Abrasion
- Being tested
- Teeth brushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teeth brushingOther
The participants will be invites to brush their teeth twice a day for 3 months using either an electric toothbrush or a mannual toothbrush and low abrasivity toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Electric Toothbrush | Experimental | Electric toothbrush + manufacturer's instructions + professional recommendations + sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) Receives: Other: Teeth brushing |
| Manual toothbrush | Active comparator | Manual toothbrush + manufacturer's instructions + professional recommendations + sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) Receives: Other: Teeth brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the gingival abrasion (GA): Macro-relief scoring
A first method for the evaluation of gingival abrasion (GA) will consist in a method of macro-relief scoring of gingival tissue as described previously by Perin et al. with skin tissue. This evaluation consists of acquiring macroscopic views of each investigated surface and then classifying them by observers according to a reference groups of defined abrasion intensity. This evaluation scoring, using photo grading technique, allow delayed and blinded scoring, independent of whole-subject appearance, thus decreasing subjectivity (Perin et al., 2000).
Five items are evaluted for each picture : erythema, inflammation, bleeding, recession and erosion of the gingiva. All items are scored from 0 to 3, 3 representing the most significant impairment.
Measured: 90 days
Secondary outcomes (5)
Comparison of gingival color;
Comparison of gingival color between baseline and time point using photographs. The technique consists of acquiring macroscopic photographs of each gingival quadrant, including an internal colored reference chart in the vicinity of the photographed gingival tissue, at each time point. Next, using an image analysis software, each photograph will be calorimetrically reconverted to be recalibrated following the colored reference chart. Then, the coloring intensity in each zone of interest [marginal (cervical free gingiva, CFG), interdental (papillary free gingiva, PFG) and mid-gingival (attached gingiva, AG)] around each tooth in each quadrant, will be extracted by observers in a double-blind manner using the color picker tool.
This method has already been applied to describe the intensity of skin coloring (red /green/blue component) as well as luminosity, the brightness and transparency (Musnier et al., 2004) and will be applied to each subject's gingival tissue.
Measured: 90 days
Presence of plaque -Plaque index, PI
Plaque index (PI) described by Silness \& Löe (Silness and Löe, 1964) uses 0 to 4 classes to assess the presence of plaque or not on six sites (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual) on all teeth, according to the following criteria: 0: absence of plaque; 1: non visible plaque but detectable with a probe; 2: visible plaque not detectable in the interproximal areas; 3: visible plaque in interdental spaces also.
Measured: 90 days
Presence of inflammation BOP
Gingival inflammation (GI) will be assessed as bleeding on marginal probing (BOP) using the index as described by Ainamo \& Bay (Ainamo and Bay, 1975). GI uses a 0 to 3 scale to measure the presence of inflammation or not on six sites (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual) on all teeth, according to the following criteria: 0: absence of inflammation; 1: visible inflammation and no bleeding; 2: visible inflammation and bleeding on probing; 3: obvious inflammation and spontaneous bleeding.
BOP is considered as dichotomous variable. BOP uses 0 and 1 scale. 0: no bleeding on probing; 1: bleeding on probing including 4 sites per tooth. The percentage of bleeding will be calculated as following: number of sites with bleeding / number of sites assessed X 100.
Measured: 90 days
Presence and/or amount of gingival recession (REC)
Gingival margin recession will be measured from the cemento-enamel junction to the marginal position of the gingiva with PCP-UNC 15 (Hu-Friedy® Chicago, IL, USA) probe. The measurements will be assessed at the middle of the buccal gingival recession.
Measured: 90 days
Probing pocket depth (PD)
PD will be measured before the test/control treatment by one and the same examiner by using the PCP-UNC 15 (Hu-Friedy® Chicago, IL, USA) probe throughout the study. The probing depth will be assessed at the buccal aspects of teeth 16,14,13,11. All measurements will be adjusted to the nearest 1.0 mm.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival AbrasionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips France Commercial
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe BOUCHARD, Pr Dr, Principal investigator, Rothschild Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375227
- Sponsor's protocol ID
- 2020-A02614-35
- Acronym
- ASTA
- Status last verified
- May 2022
- First submitted
- 26 Oct 2021
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue
- ClinicalTrials.gov ID
- NCT05375227
- Acronym / sponsor ID
- ASTA / 2020-A02614-35
- Conditions
- Gingival Abrasion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Philips France CommercialIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 16 May 2022 (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.
This is a randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study. It aims to assess gingival abrasion by the comparison of pre- to- post-brushing after a single brushing and after 12 weeks of daily home brushing using a macro-relief scoring based on photographs of the gingiva. The study also aims to assess plaque removal, gingival inflammation, gingival recession and gingival color after 12 weeks. To enter the study, adult male and female subjects attending the service of odontology at Rothschild hospital (Paris, France) will refrain from all oral hygiene procedures for 24 hours. Subjects will have the study procedure explained to them both orally and by written instructions. Eligible patients will give their written consent to participate before being included into the study. Following a baseline clinical examination for collection of the following periodontal parameters: plaque control record (PCR), bleeding on probing (BOP), gingival recession (REC), and probing pocket depths (PD), the subjects will be randomized into two balanced groups, test group assigned to the Sonicare ProtectiveClean® HX6848/92 with C2 Optimal Plaque Defense head HX9022/10 (electric toothbrush) and control group assigned to the Pierre Fabre Inava 20/100, a reference manual toothbrush. Subjects will be instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) with a low level of abrasion to minimize bias due to toothpaste abrasivity. After brushing, they will again be evaluated for primary and secondary outcomes (post-brushing). Subjects will be dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects will be instructed to brush for two minutes during each tooth brushing. The subjects will report to the study site after 12 weeks of product use, at which time they will be re-evaluated for gingival abrasion, as well as for plaque removal, gingival inflammation, gingival recession and gingival color. Data (photographs and clinical measurements) will be collected, i.e. primary and secondary variables of each patient, by blinded examiners.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study
| Arm | Type | Receives |
|---|---|---|
| Electric Toothbrush | Experimental | Other: Teeth brushingElectric toothbrush + manufacturer's instructions + professional recommendations + sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) |
| Manual toothbrush | Active comparator | Other: Teeth brushingManual toothbrush + manufacturer's instructions + professional recommendations + sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dentate males and females must be at least 18 years and not more than 75 years of age
- Patient able to understand and sign the informed consent prior to starting the study
- Patient with a minimum of 3 teeth in each of the 4 quadrants and no/or pockets >4 mm
- Ability and willingness to comply with all study requirements.
Key exclusion criteria (11 listed)
- Pregnancy
- Patient with cervical restorations
- Current smoker
- Patient with orthodontic banding
- Patient with oral lesions or periodontal diseases
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 |
|---|---|---|
| Teeth brushingThe participants will be invites to brush their teeth twice a day for 3 months using either an electric toothbrush or a mannual toothbrush and low abrasivity toothpaste | Other | Electric Toothbrush, Manual toothbrush |
Primary outcome
Evaluation of the gingival abrasion (GA): Macro-relief scoring
Time frame: 90 days
A first method for the evaluation of gingival abrasion (GA) will consist in a method of macro-relief scoring of gingival tissue as described previously by Perin et al. with skin tissue. This evaluation consists of acquiring macroscopic views of each investigated surface and then classifying them by observers according to a reference groups of defined abrasion intensity. This evaluation scoring, using photo grading technique, allow delayed and blinded scoring, independent of whole-subject appearance, thus decreasing subjectivity (Perin et al., 2000). Five items are evaluted for each picture : erythema, inflammation, bleeding, recession and erosion of the gingiva. All items are scored from 0 to 3, 3 representing the most significant impairment.
5 secondary outcomes
Comparison of gingival color;
Time frame: 90 days
Presence of plaque -Plaque index, PI
Time frame: 90 days
Presence of inflammation BOP
Time frame: 90 days
Presence and/or amount of gingival recession (REC)
Time frame: 90 days
Probing pocket depth (PD)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: No
Related trials for Gingival Abrasion
Recruiting
Evaluation of Toothbrush Bristles
Gingivitis and Periodontal Diseases
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.
Philippe BOUCHARD, Pr Dr principal investigator
Rothschild Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teeth brushing in people with Gingival Abrasion, run by Philips France Commercial at 1 site in France.
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 11 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: status not confirmed, as of the sponsor's last update on 16 May 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Watts, Dr (+33 (0)1 47 28 10 00, marc.watts@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the gingival abrasion (GA): Macro-relief scoring (time frame: 90 days). 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 16 May 2022.