Gum BleedNCT04427397
Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush
A study testing Sulcular Bristle Tip Technique (SBTT) in people with Gum Bleed, run by Tufts University at 1 site in United States.
Trial summary
In this study, all subjects will be given an electric toothbrush. Half of the participants will be instructed on how to use the Sulcular Bristle Tip Technique (SBTT). The other half of participants will be asked to follow the brushing instructions in the user manual. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gum Bleed
- What is being tested?
- Sulcular Bristle Tip Technique (SBTT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Subjects must show > 20% buccal/lingual cervical sites with bleeding on probing (BoP)
- Subjects must have > 24 natural teeth excluding third molars
- Subjects must have had a professional dental prophylaxis within three months of beginning the study
- Subjects must be willing to brush with electric toothbrush twice daily.
- Subjects who are randomized into Group 1 must be willing to be taught and to demonstrate the SBTT
- Subjects who are randomized into Group 2 must be willing to follow the Sonicare DFU from Philips Oral Healthcare; however, will otherwise be uninstructed until after the study has been completed
- Subjects must be willing to refrain from any oral hygiene for at least 12-18 hours prior to each study follow-up visit.
Who cannot join
- Subjects who use tobacco products
- Subjects who are currently pregnant (self-reported) due to the greater bleeding tendency caused by hormonal changes
- Subjects with fixed or removable orthodontic appliances
- Subjects whose restorations violate or potentially violate the biologic width.
- Subjects with irregular restoration margins or overhanging margins within 1mm of the crest of the marginal gingiva.
- Antibiotic treatment at the time of the initial examination or during the month prior
Show all 10Show fewer
- Subjects with cervical probing depth >3 mm
- Subjects with systemic diseases that affect the gingiva
- Subjects taking medications that affect the gingiva
- Subjects who cannot read/write/speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: The Effects of Using the Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush in Reducing Bleeding on Probing and Plaque Removal: A Randomized Control Clinical Trial
In this study, all subjects will be given an electric toothbrush. Half of the participants will be instructed on how to use the Sulcular Bristle Tip Technique (SBTT). The other half of participants will be asked to follow the brushing instructions in the user manual. The study's primary aim is to compare the use of the SBTT with an electric toothbrush in reducing bleeding on probing with the use of an electric toothbrush used without personal professional instruction.
- Conditions
- Gum Bleed
- Being tested
- Sulcular Bristle Tip Technique (SBTT)
- Keywords
- sulcular bristle tip technique, SBTT, brushing, plaque
- Medical subject headings
- Gingival Hemorrhage, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulcular Bristle Tip Technique (SBTT)Other
Tooth brushing should begin on the distal of the most posterior tooth on one side of the mouth and proceed anteriorly and then posteriorly overlapping areas to the most distal surface of the most posterior tooth on the contra lateral side. The lingual is done in like fashion ending where the brushing began. The opposing arch is brushed in the same manner. When moving from one area to the next, disengage the brush bristles entirely off the teeth to allow them to straighten, and then reposition the brush in the next overlapping area. Do not to drag the bristle tips from one area to the next area. For the lingual of the anterior teeth, the narrow portion of the brush is used with the exact same technique as described above. For the lingual of the mandibular molars, the angulation of the toothbrush bristles to the tooth needs to be somewhat more perpendicular to the tooth than on the buccal to ensure that the bristle tips enter the gingival crevice.
| Study group | Role | What they receive |
|---|---|---|
| Sulcular Bristle Tip Technique (SBTT) | Experimental | This test group will receive formal instruction on the Sulcular Bristle Tip Technique (SBTT). Receives: Other: Sulcular Bristle Tip Technique (SBTT) |
| User manual of the electric toothbrush (DFU) | No intervention | This control group will be asked to read and use the instructions found in the user manual of the electric toothbrush (DFU). No formal instruction will be provided. The DFU accompany the electric toothbrush regardless of the subject's participation in the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bleeding on probing (BOP)
To compare the use of the SBTT with an electric toothbrush in reducing BOP with the use of an electric toothbrush used without personal professional instruction.
Measured: Baseline through study completion, an average of 4 months
Secondary outcomes (3)
Effectiveness of professional cleaning
To compare whether a dental professional's (DP) cleaning a subject's teeth using an electric toothbrush with the SBTT is more effective in removing cervical plaque than the patient self-cleaning using electric toothbrush with the SBTT at the initial visit and after four months
Measured: Baseline and 4 months
Change in plaque
To compare the plaque removal of each subject at the initial visit with their plaque removal after four months of using the SBTT. To compare the plaque removal of the DP at the initial visit with the DP's plaque removal at the fourth month visit.
Measured: Baseline and 4 months
Evaluating deformation of toothbrush bristles
To compare the deformation of toothbrush bristles when used by patients using the SBTT with an electric toothbrush with the deformation of the toothbrush bristles with patients using an electric toothbrush uninstructed and whether the deformation is associated with BoP in each group.
Measured: Baseline through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start29 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Study team has determined that given time and resource restraints, study is to be closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gum BleedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Livia Valverde, Tufts University School of Dental Medicine
- Investigators
- Livia Valverde, DMD, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427397
- Sponsor's protocol ID
- STUDY00000432
- Status last verified
- Apr 2024
- First submitted
- 5 Jun 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using the Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush in Reducing Bleeding on Probing and Plaque Removal: A Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT04427397
- Acronym / sponsor ID
- STUDY00000432
- Conditions
- Gum Bleed
- Keywords
- sulcular bristle tip technique, SBTT, brushing, plaque
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team has determined that given time and resource restraints, study is to be closed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Jun 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.
In this study, all subjects will be given an electric toothbrush. Half of the participants will be instructed on how to use the Sulcular Bristle Tip Technique (SBTT). The other half of participants will be asked to follow the brushing instructions in the user manual. The study's primary aim is to compare the use of the SBTT with an electric toothbrush in reducing bleeding on probing with the use of an electric toothbrush used without personal professional instruction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulcular Bristle Tip Technique (SBTT) | Experimental | Other: Sulcular Bristle Tip Technique (SBTT)This test group will receive formal instruction on the Sulcular Bristle Tip Technique (SBTT). |
| User manual of the electric toothbrush (DFU) | No intervention | –This control group will be asked to read and use the instructions found in the user manual of the electric toothbrush (DFU). No formal instruction will be provided. The DFU accompany the electric toothbrush regardless of the subject's participation in the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age
- Subjects must show > 20% buccal/lingual cervical sites with bleeding on probing (BoP)
- Subjects must have > 24 natural teeth excluding third molars
- Subjects must have had a professional dental prophylaxis within three months of beginning the study
- Subjects must be willing to brush with electric toothbrush twice daily.
Key exclusion criteria (10 listed)
- Subjects who use tobacco products
- Subjects who are currently pregnant (self-reported) due to the greater bleeding tendency caused by hormonal changes
- Subjects with fixed or removable orthodontic appliances
- Subjects whose restorations violate or potentially violate the biologic width.
- Subjects with irregular restoration margins or overhanging margins within 1mm of the crest of the marginal gingiva.
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 |
|---|---|---|
| Sulcular Bristle Tip Technique (SBTT)Tooth brushing should begin on the distal of the most posterior tooth on one side of the mouth and proceed anteriorly and then posteriorly overlapping areas to the most distal surface of the most posterior tooth on the contra lateral side. The lingual is done in like fashion ending where the brushing began. The opposing arch is brushed in the same manner. When moving from one area to the next, disengage the brush bristles entirely off the teeth to allow them to straighten, and then reposition the brush in the next overlapping area. Do not to drag the bristle tips from one area to the next area. For the lingual of the anterior teeth, the narrow portion of the brush is used with the exact same technique as described above. For the lingual of the mandibular molars, the angulation of the toothbrush bristles to the tooth needs to be somewhat more perpendicular to the tooth than on the buccal to ensure that the bristle tips enter the gingival crevice. | Other | Sulcular Bristle Tip Technique (SBTT) |
Primary outcome
Change in bleeding on probing (BOP)
Time frame: Baseline through study completion, an average of 4 months
To compare the use of the SBTT with an electric toothbrush in reducing BOP with the use of an electric toothbrush used without personal professional instruction.
3 secondary outcomes
Effectiveness of professional cleaning
Time frame: Baseline and 4 months
Change in plaque
Time frame: Baseline and 4 months
Evaluating deformation of toothbrush bristles
Time frame: Baseline through study completion, an average of 4 months
Results and safety
The study was stopped early (reason given: Study team has determined that given time and resource restraints, study is to be closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
Livia Valverde, DMD principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulcular Bristle Tip Technique (SBTT) in people with Gum Bleed, run by Tufts University 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Apr 2024. 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 was stopped early (reason given: Study team has determined that given time and resource restraints, study is to be closed). Results are not available in the source record.
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 bleeding on probing (BOP) (time frame: Baseline through study completion, an average of 4 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 10 Apr 2024.