CClinicalTrials.gg
Not yet recruitingNCT06779279D-F-H-17-DecUpdated Jan 22, 2025

Adjunctive Oral Hygiene Aids in Reducing Oral Hygiene Parameters Among Orthodontic Patients

An interventional study of Water flosser and super flosser and Orthodontic brush in Gingival Bleeding and Dental Plaque Accumulation, sponsored by sudhir rama varma. Not yet recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by sudhir rama varma · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gingival Bleeding
  • Dental Plaque Accumulation

Keywords

  • waterflosser
  • superfloss
  • gingival bleeding
  • Dental Plaque
03

In context

Dental Plaque

314 studies on the registry are indexed under Dental Plaque; 54 are open to participants now.

This study's planned enrollment of 102 is above the median of 59 across 279 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

sudhir rama varma is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants aged 18-35 years undergoing orthodontic treatment and
  • systemically healthy without habits

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Active comparator
    water flosser and super flosser

    One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterflosser®.

    Device: Water flosser and super flosser

  • Active comparator
    Orthodontic brushes

    One side of the mouth will be brushed with Orthodontic brushes

    Device: Orthodontic brush

Interventions

  • DeviceWater flosser and super flosser

    Participant will use in one area superfloss and the other area waterfloss

  • DeviceOrthodontic brush

    Participant will use orthodontic brush to brush in the upper/lower quadrant

06

What researchers measure

Primary outcomes

  1. Number of Participants with Gingival Bleeding

    Gingival bleeding scores will be evaluted 0-no gingival bleeding 1. mild gingival bleeding 2. moderate gingival bleeding 3. spontaneous gingival bleeding

    Time frame: 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 1. Upto 1/3rd of the tooth surface 2. more than 1/3rd and less than 2/3rd of tooth surface 3. more than 2/3rd of tooth surface

    Time frame: Through study completion, an average of 1 month

07

Study locations

1 site
  • Ajman university
    Ajman, United Arab Emirates
08

References and documents

Individual participant data

Plan to share: Yes — study protocol, Data and statistical analysis

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06779279
Lead sponsor
sudhir rama varma
Responsible party
sudhir rama varma (Clinical Assistant Professor, Ajman University) — Sponsor-investigator
First posted
Jan 16, 2025
Start date
Feb 10, 2025 (estimated)
Primary completion
Mar 20, 2025 (estimated)
Completion
Mar 26, 2025 (estimated)
Last update
Jan 22, 2025

Study contacts

Sudhir Rama Varma, MDS
Contact
s.varma@ajman.ac.ae
971506595075
sudhir Rama Varma, MDS
principal investigator · Ajman University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion