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NCT Number: NCT06779279

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

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.

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Key information

Conditions

Gingival Bleeding Dental Deposits Dental Plaque Dental Plaque Accumulation Gingival Diseases Gingival Hemorrhage Hemorrhage Mouth Diseases Oral Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajman university

Ajman, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Water flosser and super flosser

Device

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

Orthodontic brush

Device

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

Primary outcomes

  1. 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

    • mild gingival bleeding
    • moderate gingival bleeding
    • spontaneous gingival bleeding

Secondary outcomes

  1. Number of Participants with Dental Plaque

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sudhir Rama Varma, MDS

CONTACT

[email protected]

971506595075

Sponsors and collaborators

Lead sponsor

sudhir rama varma

Other

Registry information

Official study title

Adjunctive Oral Hygiene Aids in Reducing Commonly Seen Oral Hygiene Parameters Among Orthodontic Patients: a Randomized Controlled Trial

Acronym: D-F-H-17-Dec

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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