Dental Plaque Induced GingivitisNCT03416985
A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
A study testing Oral B Healthy Clean Manual Toothbrush, BURST Sonic Oral Care and Philipps Sonicare DiamondClean 300 Series in people with Dental Plaque Induced Gingivitis and Dental Plaque, run by University of California, Los Angeles at 1 site in United States.
Trial summary
It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque Induced Gingivitis, Dental Plaque
- What is being tested?
- Oral B Healthy Clean Manual Toothbrush, BURST Sonic Oral Care and Philipps Sonicare DiamondClean 300 Series
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good overall health
- At least 20 teeth present, not including 3rd Molars
- Non-smoker
Who cannot join
- Poor manual dexterity or mentally handicap;
- Presence of removable intra-oral prosthesis
- Current orthodontic therapy
- Severe Periodontal condition or caries teeth in need of immediate attention
- Pregnant women
- Subjects that use medications that may effect oral health
- No Systemic diseases/conditions such as diabetes mellitus, heart disease.
- Use of plaque inhibiting toothpaste, mouthwash, interdental flossing in the period of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Dentistry
Los Angeles, California, 90095
About this study
It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.
Read the detailed description
The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made.
Study design: randomised, single blinded, parallel.
After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0.
The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations.
At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush.
The subjects will be instructed to brush twice a day for a period of 2 minutes (following the programmed toothbrush timer) and refrain from using dental floss, tooth pick or any mechanical oral hygiene aid for the period of the study.
On the second visit at 14 days (T2) and third visit at 30 days (T3), additional GI and PI readings will be taken and data will be recorded. All measurements and clinical examinations will be performed by a single blinded examiner. Evaluation on teeth will be made on six teeth #3,7,12,19,23 and 28 (mesio-buccal, buccal, disto-buccal and mesio-lingual, lingual, disto-lingual) following the Silness-Loe Index.
- Conditions
- Dental Plaque Induced Gingivitis, Dental Plaque
- Being tested
- Oral B Healthy Clean Manual Toothbrush, BURST Sonic Oral Care, Philipps Sonicare DiamondClean 300 Series
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral B Healthy Clean Manual ToothbrushDevice
Manual Toothbrush
BURST Sonic Oral CareDevice
Electric sonic toothbrush
Philipps Sonicare DiamondClean 300 SeriesDevice
Electric pulsating toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Manual Toothbrush | Active comparator | Patients will be asked to use a manual toothbrush for 30 days Receives: Device: Oral B Healthy Clean Manual Toothbrush |
| Sonic Toothbrush | Active comparator | Patients will be asked to use a sonic toothbrush for 30 days Receives: Device: BURST Sonic Oral Care |
| Pulsating Toothbrush | Active comparator | Patients will be asked to use a pulsating toothbrush for 30 days Receives: Device: Philipps Sonicare DiamondClean 300 Series |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Measured: Baseline, 1 month
Gingival Index
gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing.
Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start2 Jan 2018
- Primary completion1 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental Plaque Induced GingivitisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan PiAnfruns, DMD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416985
- Sponsor's protocol ID
- 17-001622
- Status last verified
- Dec 2019
- First submitted
- 24 Jan 2018
- Last updated
- 24 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
- ClinicalTrials.gov ID
- NCT03416985
- Acronym / sponsor ID
- 17-001622
- Conditions
- Dental Plaque Induced Gingivitis, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Posted 24 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.
Detailed description
The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made.
Study design: randomised, single blinded, parallel.
After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0.
The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations.
At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush.
The subjects will be instructed to brush twice a day for a period of 2 minutes (following the programmed toothbrush timer) and refrain from using dental floss, tooth pick or any mechanical oral hygiene aid for the period of the study.
On the second visit at 14 days (T2) and third visit at 30 days (T3), additional GI and PI readings will be taken and data will be recorded. All measurements and clinical examinations will be performed by a single blinded examiner. Evaluation on teeth will be made on six teeth #3,7,12,19,23 and 28 (mesio-buccal, buccal, disto-buccal and mesio-lingual, lingual, disto-lingual) following the Silness-Loe Index.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Toothbrush | Active comparator | Device: Oral B Healthy Clean Manual ToothbrushPatients will be asked to use a manual toothbrush for 30 days |
| Sonic Toothbrush | Active comparator | Device: BURST Sonic Oral CarePatients will be asked to use a sonic toothbrush for 30 days |
| Pulsating Toothbrush | Active comparator | Device: Philipps Sonicare DiamondClean 300 SeriesPatients will be asked to use a pulsating toothbrush for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Good overall health
- At least 20 teeth present, not including 3rd Molars
- Non-smoker
Key exclusion criteria (8 listed)
- Poor manual dexterity or mentally handicap;
- Presence of removable intra-oral prosthesis
- Current orthodontic therapy
- Severe Periodontal condition or caries teeth in need of immediate attention
- Pregnant women
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 |
|---|---|---|
| Oral B Healthy Clean Manual ToothbrushManual Toothbrush | Device | Manual Toothbrush |
| BURST Sonic Oral CareElectric sonic toothbrush | Device | Sonic Toothbrush |
| Philipps Sonicare DiamondClean 300 SeriesElectric pulsating toothbrush | Device | Pulsating Toothbrush |
Primary outcome
Plaque Index
Time frame: Baseline, 1 month
plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Gingival Index
Time frame: Baseline, 1 month
gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Plaque Induced Gingivitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Not yet recruitingPhase 1
Taste Acceptance and Effectiveness of Hyaluronic Acid and Chlorhexidine Mouthwashes in Children With Gingivitis
Plaque Induced Gingival Disease
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 Oral B Healthy Clean Manual Toothbrush, BURST Sonic Oral Care and Philipps Sonicare DiamondClean 300 Series in people with Dental Plaque Induced Gingivitis and Dental Plaque, run by University of California, Los Angeles 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 3 inclusion and 8 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 24 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 24 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plaque Index (time frame: Baseline, 1 month). The study lists 2 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 24 Dec 2019.