Gingival BleedingD-F-H-17-DecNCT06779279
Adjunctive Oral Hygiene Aids in Reducing Oral Hygiene Parameters Among Orthodontic Patients
A study testing Water flosser and super flosser and Orthodontic brush in people with Gingival Bleeding and Dental Plaque Accumulation, run by sudhir rama varma at 1 site in United Arab Emirates.
Trial summary
Adult orthodontic patients aged 18-30 were included in a randomised, singleblind clinical research using a split-mouth design at a dental clinic. Both theWaterflosser® and the Super-Floss® water flossers are manufactured by Oral-B. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Bleeding, Dental Plaque Accumulation
- What is being tested?
- Water flosser and super flosser and Orthodontic brush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 10 Feb 2025to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged 18-35 years undergoing orthodontic treatment and
- systemically healthy without habits
Who cannot join
- Participants not undergoing orthodontic treatment and participants undergoing orthodontic treatment in the included age category but with systemic conditions prevalent
- missing teeth and
- treated previously for periodontal conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adjunctive Oral Hygiene Aids in Reducing Commonly Seen Oral Hygiene Parameters Among Orthodontic Patients: a Randomized Controlled Trial
Adult orthodontic patients aged 18-30 were included in a randomised, singleblind clinical research using a split-mouth design at a dental clinic. Both theWaterflosser® and the Super-Floss® water flossers are manufactured by Oral-B.
Read the detailed description
In order to reduce gingival inflammation and remove subgingival plaque, oral hygiene therapy is necessary. The available evidence indicates that mechanical plaque control, which patients administer themselves daily, is the most important factor in managing and reducing plaque accumulation. Aim: This research aimed to determine whether Waterflosser or Superfloss was more effective in lowering the gingival bleeding score and plaque. Methods: Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterflosser® and the Super-Floss® water flossers are manufactured by Oral- B.
- Conditions
- Gingival Bleeding, Dental Plaque Accumulation
- Being tested
- Water flosser and super flosser, Orthodontic brush
- Keywords
- waterflosser, superfloss, gingival bleeding, Dental Plaque
- Medical subject headings
- Gingival Hemorrhage, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water flosser and super flosserDevice
Participant will use in one area superfloss and the other area waterfloss
Orthodontic brushDevice
Participant will use orthodontic brush to brush in the upper/lower quadrant
| Study group | Role | What they receive |
|---|---|---|
| water flosser and super flosser | Active comparator | One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterflosser®. Receives: Device: Water flosser and super flosser |
| Orthodontic brushes | Active comparator | One side of the mouth will be brushed with Orthodontic brushes Receives: Device: Orthodontic brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Gingival Bleeding
Gingival bleeding scores will be evaluted 0-no gingival bleeding
- mild gingival bleeding
- moderate gingival bleeding
- spontaneous gingival bleeding
Measured: Through study completion, an average of 1 month
Secondary outcomes (1)
Number of Participants with Dental Plaque
Dental Plaque scores will be evaluated 0-No dental plaque
- Upto 1/3rd of the tooth surface
- more than 1/3rd and less than 2/3rd of tooth surface
- more than 2/3rd of tooth surface
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start10 Feb 2025 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion26 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival BleedingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study comprised 18-35-year-old girls and boys planning orthodontic treatment. Participants had upper right tooth to lower left molar braces, a pocket depth of 3 mm, and had not flossed in 24 hours. Smoking, periodontal disease, missing teeth, voids between teeth in the arch, and systemic disorders disqualified participants.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sudhir rama varma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sudhir rama varma, Ajman University
- Investigators
- sudhir Rama Varma, MDS, Principal investigator, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779279
- Sponsor's protocol ID
- D-F-H-17-Dec
- Acronym
- D-F-H-17-Dec
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol, Data and statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Oral Hygiene Aids in Reducing Commonly Seen Oral Hygiene Parameters Among Orthodontic Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06779279
- Acronym / sponsor ID
- D-F-H-17-Dec / D-F-H-17-Dec
- Conditions
- Gingival Bleeding, Dental Plaque Accumulation
- Keywords
- waterflosser, superfloss, gingival bleeding, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- sudhir rama varmaUniversity, hospital or other
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 26 Mar 2025 (estimated)
- First posted
- 16 Jan 2025 (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.
Adult orthodontic patients aged 18-30 were included in a randomised, singleblind clinical research using a split-mouth design at a dental clinic. Both theWaterflosser® and the Super-Floss® water flossers are manufactured by Oral-B.
Detailed description
In order to reduce gingival inflammation and remove subgingival plaque, oral hygiene therapy is necessary. The available evidence indicates that mechanical plaque control, which patients administer themselves daily, is the most important factor in managing and reducing plaque accumulation. Aim: This research aimed to determine whether Waterflosser or Superfloss was more effective in lowering the gingival bleeding score and plaque. Methods: Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterflosser® and the Super-Floss® water flossers are manufactured by Oral- B.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study comprised 18-35-year-old girls and boys planning orthodontic treatment. Participants had upper right tooth to lower left molar braces, a pocket depth of 3 mm, and had not flossed in 24 hours. Smoking, periodontal disease, missing teeth, voids between teeth in the arch, and systemic disorders disqualified participants.
| Arm | Type | Receives |
|---|---|---|
| water flosser and super flosser | Active comparator | Device: Water flosser and super flosserOne side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterflosser®. |
| Orthodontic brushes | Active comparator | Device: Orthodontic brushOne side of the mouth will be brushed with Orthodontic brushes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants aged 18-35 years undergoing orthodontic treatment and
- systemically healthy without habits
Key exclusion criteria (3 listed)
- Participants not undergoing orthodontic treatment and participants undergoing orthodontic treatment in the included age category but with systemic conditions prevalent
- missing teeth and
- treated previously for periodontal conditions
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 |
|---|---|---|
| Water flosser and super flosserParticipant will use in one area superfloss and the other area waterfloss | Device | water flosser and super flosser |
| Orthodontic brushParticipant will use orthodontic brush to brush in the upper/lower quadrant | Device | Orthodontic brushes |
Primary outcome
Number of Participants with Gingival Bleeding
Time frame: Through study completion, an average of 1 month
Gingival bleeding scores will be evaluted 0-no gingival bleeding 1. mild gingival bleeding 2. moderate gingival bleeding 3. spontaneous gingival bleeding
1 secondary outcome
Number of Participants with Dental Plaque
Time frame: Through study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Yes. study protocol, Data and statistical analysis
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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.
sudhir Rama Varma, MDS principal investigator
Ajman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water flosser and super flosser and Orthodontic brush in people with Gingival Bleeding and Dental Plaque Accumulation, run by sudhir rama varma at 1 site in United Arab Emirates.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Jan 2025. 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 Arab Emirates. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sudhir Rama Varma, MDS (971506595075, s.varma@ajman.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Gingival Bleeding (time frame: Through study completion, an average of 1 month). 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 22 Jan 2025.