Halitosis During Active Orthodontic Treatment

NCT ID: NCT03901625

Last Updated: 2019-04-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-13

Study Completion Date

2019-10-11

Brief Summary

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To determine the effect of different cleaning methods and devices in reducing halitosis during active orthodontic treatment.

Detailed Description

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. Observer - blind clinical trial, randomly divided into four groups, A, B, C and D. each group will undergo clinical evaluation and oral malodor assessment and they will be assigned electric or manual toothbrushes with super floss or water floss respectively.clinical evaluation will include plaque index (PI), gingival bleeding index (GBI), bracket index.and halitosis will be measured by halimeter .

Measurements and time frame: Initial measurements (T0), after two weeks (T1), and after four weeks (T2) ( according to previous studies that uses the same period of time for measurements),17, 18 plaque index (PI), gingival bleeding index (GBI), bracket index and halimeter reading .

During the first week after the start of the study (T0)

Conditions

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Halitosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ManualTB+Floss

Cleaning teeth with a manual toothbrush and a dental floss three times a day.

Group Type ACTIVE_COMPARATOR

Manual Toothbrush

Intervention Type DEVICE

A manual toothbrush is used to clean teeth surfaces.

Dental floss

Intervention Type DEVICE

A dental floss is used to clean inter-proximal areas.

ManualTB+Waterjet

Cleaning teeth with a manual toothbrush and a waterjet three times a day.

Group Type EXPERIMENTAL

Manual Toothbrush

Intervention Type DEVICE

A manual toothbrush is used to clean teeth surfaces.

Waterjet

Intervention Type DEVICE

A waterjet is used to clean inter-proximal areas.

Electric TB+Floss

Cleaning teeth with an electric toothbrush and dental floss three times a day .

Group Type EXPERIMENTAL

Dental floss

Intervention Type DEVICE

A dental floss is used to clean inter-proximal areas.

Electric Toothbrush

Intervention Type DEVICE

An electric toothbrush is used to clean teeth surfaces.

Electric TB +Waterjet

Cleaning teeth with an electric toothbrush and a waterjet three times a day .

Group Type EXPERIMENTAL

Waterjet

Intervention Type DEVICE

A waterjet is used to clean inter-proximal areas.

Electric Toothbrush

Intervention Type DEVICE

An electric toothbrush is used to clean teeth surfaces.

Interventions

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Manual Toothbrush

A manual toothbrush is used to clean teeth surfaces.

Intervention Type DEVICE

Dental floss

A dental floss is used to clean inter-proximal areas.

Intervention Type DEVICE

Waterjet

A waterjet is used to clean inter-proximal areas.

Intervention Type DEVICE

Electric Toothbrush

An electric toothbrush is used to clean teeth surfaces.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. participants with fixed orthodontic appliance.
2. participants age 14 years and above and didn't have mental of physical disabilities.
3. participants willing to comply with given oral hygiene instructions.

Exclusion Criteria

1. patients with mental retardation.
2. patients with systematic diseases.
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Omar Alkadhi

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Riyadh Elm University

Riyadh, Riyadh Region, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Omar H AlKadhi, BDS, MSc

Role: CONTACT

+966505154754

Facility Contacts

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Omar AlKadhi

Role: primary

Other Identifiers

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FPGRP/43734003/316

Identifier Type: -

Identifier Source: org_study_id

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