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

NCT ID: NCT06554938

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2024-02-10

Brief Summary

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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

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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

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Gingival Bleeding Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Randomized trial by lots

Study Groups

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water pik

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

Group Type ACTIVE_COMPARATOR

water pik

Intervention Type DEVICE

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

Super floss

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

Group Type ACTIVE_COMPARATOR

Super floss

Intervention Type DEVICE

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

Interventions

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water pik

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

Intervention Type DEVICE

Super floss

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

Intervention Type DEVICE

Other Intervention Names

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oral irrigator Dental floss

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ajman University

OTHER

Sponsor Role lead

Responsible Party

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sudhir rama varma

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ajman University

Ajman, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

Other Identifiers

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D-F-H-31-Oct-ii

Identifier Type: -

Identifier Source: org_study_id

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