Gingival BleedingNCT06554938
Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients.
A study testing water pik and Super floss in people with Gingival Bleeding and Dental Plaque, run by Ajman University at 1 site in United Arab Emirates.
Trial summary
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 Waterpik® 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
- What is being tested?
- water pik and Super floss
- 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 Nov 2023to 10 Feb 2024
- 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 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.
About this study
Official title: Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients. A Randomized Controlled Trial
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 Waterpik® 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 Waterpik 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 Waterpik® and the Super-Floss® water flossers are manufactured by Oral-B.
- Conditions
- Gingival Bleeding, Dental Plaque
- Being tested
- water pik, Super floss
- Keywords
- Dental plaque, Gingival Bleeding, Oral irrigator, waterpik, super floss
- 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 pikDevice
Also called oral irrigator
One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.
Super flossDevice
Also called Dental floss
One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.
| Study group | Role | What they receive |
|---|---|---|
| water pik | Active comparator | One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®. Receives: Device: water pik |
| Super floss | Active comparator | One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®. Receives: Device: Super floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival bleeding
Gingival bleeding scores will be evaluted
Measured: 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention
Dental plaque
Dental plaque scores will be evaluated
Measured: 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start10 Nov 2023
- Primary completion10 Jan 2024
- Study completion10 Feb 2024
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
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sudhir rama varma, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554938
- Sponsor's protocol ID
- D-F-H-31-Oct-ii
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 15 Aug 2024
- 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 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06554938
- Acronym / sponsor ID
- D-F-H-31-Oct-ii
- Conditions
- Gingival Bleeding, Dental Plaque
- Keywords
- Dental plaque, Gingival Bleeding, Oral irrigator, waterpik, super floss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 15 Aug 2024 (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, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterpik® 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 Waterpik 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 Waterpik® and the Super-Floss® water flossers are manufactured by Oral-B.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- 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 pik | Active comparator | Device: water pikOne side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®. |
| Super floss | Active comparator | Device: Super flossOne side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®. |
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 pikAlso: oral irrigatorOne side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®. | Device | water pik |
| Super flossAlso: Dental flossOne side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®. | Device | Super floss |
Primary outcome
Gingival bleeding
Time frame: 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention
Gingival bleeding scores will be evaluted
Dental plaque
Time frame: 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention
Dental plaque scores will be evaluated
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 15 Aug 2024.
- 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. 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 water pik and Super floss in people with Gingival Bleeding and Dental Plaque, run by Ajman University 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: finished, as of the sponsor's last update on 15 Aug 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 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?
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?
Gingival bleeding (time frame: 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention). 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 15 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.