Adjunctive Oral Hygiene Aids in Reducing Oral Hygiene Parameters Among Orthodontic Patients (D-F-H-17-Dec)

January 19, 2025 updated by: sudhir rama varma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Participant will use in one area superfloss and the other area waterfloss
Active Comparator: Orthodontic brushes
One side of the mouth will be brushed with Orthodontic brushes
Device: Orthodontic brush
Participant will use orthodontic brush to brush in the upper/lower quadrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  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
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

sudhir rama varma

Investigators

  • Principal Investigator: sudhir Rama Varma, MDS, Ajman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2025

Primary Completion (Estimated)

March 20, 2025

Study Completion (Estimated)

March 26, 2025

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-F-H-17-Dec

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol, Data and statistical analysis

IPD Sharing Time Frame

Will be available from start of the study till 12 months

IPD Sharing Access Criteria

The data will be shared upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingival Bleeding

Clinical Trials on Water flosser and super flosser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe