Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients.

August 12, 2024 updated by: sudhir rama varma, Ajman University

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.

Study Overview

Status

Completed

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 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 Type

Interventional

Enrollment (Actual)

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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: water pik
One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.
Device: water pik
One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.
Other Names:
  • oral irrigator
Active Comparator: Super floss
One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.
Device: Super floss
One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.
Other Names:
  • Dental floss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention
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
24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention

Collaborators and Investigators

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

Sponsor

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 (Actual)

November 10, 2023

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-F-H-31-Oct-ii

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

The data will be shared when requested

IPD Sharing Access Criteria

The data can be shared by Email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • 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

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.

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