PeriodontitisNCT04254770
At-Home Care for Subjects With Periodontitis
A study testing ADA approved Manual Toothbrush and Marketed Power Toothbrush in people with Periodontitis and Dental Plaque, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Dental Plaque
- What is being tested?
- ADA approved Manual Toothbrush and Marketed Power Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 10 Aug 2020
- 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
- Between the ages of 18-75 years
- Exhibiting Stage I or II periodontitis
- Minimum of 20 'scorable' teeth (excluding 3rd molars)
- Regular manual toothbrush user
- Have a minimum average plaque score of > 1.8 per Modified Plaque Index scoring with 3-6 hours plaque accumulation
- Agree to desist use of interproximal cleaning aids and other prohibited devices or medicaments during the study period
- Be a non-smoker (> 10 years), or never smoker
Who cannot join
- Have a cardiac pacemaker or implanted cardiac defibrillator
- Have uncontrolled Insulin-Dependent Diabetes Have current use of antibiotic medications or use within 4 weeks of enrollment
- Have current use of prescription-dose anti-inflammatory medications or anticoagulants Have excessive gingival recession, per Investigator/Examiner discretion
- Have heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
- Have had a professional prophylaxis within 4 weeks of the study
- Prior chemotherapy, immunotherapy or radiation therapy within last 10 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-design Study to Evaluate the Effects of Home Use of the Sonicare Powered Toothbrush and a Manual Toothbrush on Subjects With Periodontitis
The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. This study, therefore, will specifically include and document that a subject exhibits periodontitis upon study entry, and measure the ensuing response following professional treatment of scaling and root planing, followed by home use of the assigned study products (powered or manual toothbrushing).
- Conditions
- Periodontitis, Dental Plaque
- Being tested
- ADA approved Manual Toothbrush, Marketed Power Toothbrush
- Medical subject headings
- Periodontitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADA approved Manual ToothbrushDevice
ADA approved Manual Toothbrush
Marketed Power ToothbrushDevice
Marketed Power Toothbrush
| Study group | Role | What they receive |
|---|---|---|
| ADA (American Dental Association) approved Manual Toothbrush | Active comparator | Not described Receives: Device: ADA approved Manual Toothbrush |
| Marketed Power Toothbrush | Experimental | Not described Receives: Device: Marketed Power Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
Measured: 6 months
Secondary outcomes (3)
Change in supragingival plaque, as measured by Modified Plaque Index
Measured: 6 months
Change in clinical attachment level
Measured: 6 months
Change in periodontitis, as measured by probing pocket depth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start6 Jan 2020
- Primary completion10 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254770
- Sponsor's protocol ID
- OHC_OHC_Anthony_2019_10606
- Status last verified
- Jan 2022
- First submitted
- 29 Jan 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins W, Starke EM, Nelson M, Milleman K, Milleman J, Ward M. The effects of scaling and root planing plus home oral hygiene maintenance in Stage I/II periodontitis population: A 24-week randomized clinical trial. Int J Dent Hyg. 2024 Aug;22(3):727-735. doi: 10.1111/idh.12783. Epub 2024 Jan 30.
PubMed 38289823
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-design Study to Evaluate the Effects of Home Use of the Sonicare Powered Toothbrush and a Manual Toothbrush on Subjects With Periodontitis
- ClinicalTrials.gov ID
- NCT04254770
- Acronym / sponsor ID
- OHC_OHC_Anthony_2019_10606
- Conditions
- Periodontitis, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 5 Feb 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.
The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. This study, therefore, will specifically include and document that a subject exhibits periodontitis upon study entry, and measure the ensuing response following professional treatment of scaling and root planing, followed by home use of the assigned study products (powered or manual toothbrushing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADA (American Dental Association) approved Manual Toothbrush | Active comparator | Device: ADA approved Manual Toothbrush |
| Marketed Power Toothbrush | Experimental | Device: Marketed Power Toothbrush |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between the ages of 18-75 years
- Exhibiting Stage I or II periodontitis
- Minimum of 20 'scorable' teeth (excluding 3rd molars)
- Regular manual toothbrush user
- Have a minimum average plaque score of > 1.8 per Modified Plaque Index scoring with 3-6 hours plaque accumulation
Key exclusion criteria (6 listed)
- Have a cardiac pacemaker or implanted cardiac defibrillator
- Have uncontrolled Insulin-Dependent Diabetes Have current use of antibiotic medications or use within 4 weeks of enrollment
- Have current use of prescription-dose anti-inflammatory medications or anticoagulants Have excessive gingival recession, per Investigator/Examiner discretion
- Have heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
- Have had a professional prophylaxis within 4 weeks of the study
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 |
|---|---|---|
| ADA approved Manual ToothbrushADA approved Manual Toothbrush | Device | ADA (American Dental Association) approved Manual Toothbrush |
| Marketed Power ToothbrushMarketed Power Toothbrush | Device | Marketed Power Toothbrush |
Primary outcome
Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
Time frame: 6 months
3 secondary outcomes
Change in supragingival plaque, as measured by Modified Plaque Index
Time frame: 6 months
Change in clinical attachment level
Time frame: 6 months
Change in periodontitis, as measured by probing pocket depth
Time frame: 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 25 Jan 2022.
- Derived from this study: PubMed 38289823Jenkins W, Starke EM, Nelson M, Milleman K, Milleman J, Ward M. The effects of scaling and root planing plus home oral hygiene maintenance in Stage I/II periodontitis population: A 24-week randomized clinical trial. Int J Dent Hyg. 2024 Aug;22(3):727-735. doi: 10.1111/idh.12783. Epub 2024 Jan 30.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADA approved Manual Toothbrush and Marketed Power Toothbrush in people with Periodontitis and Dental Plaque, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
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 7 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 25 Jan 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 United States. 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 symptoms of inflammation of the periodontium, as measured by Bleeding on Probing. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04254770, which also lists 1 linked publication.
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 Jan 2022.