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Halitosis During Active Orthodontic Treatment

R

Riyadh Colleges of Dentistry and Pharmacy

Status

Unknown

Conditions

Halitosis

Treatments

Device: Waterjet
Device: Electric Toothbrush
Device: Dental floss
Device: Manual Toothbrush

Study type

Interventional

Funder types

Other

Identifiers

NCT03901625
FPGRP/43734003/316

Details and patient eligibility

About

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

Full description

. 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)

Enrollment

60 estimated patients

Sex

All

Ages

14 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 4 patient groups

ManualTB+Floss
Active Comparator group
Description:
Cleaning teeth with a manual toothbrush and a dental floss three times a day.
Treatment:
Device: Dental floss
Device: Manual Toothbrush
ManualTB+Waterjet
Experimental group
Description:
Cleaning teeth with a manual toothbrush and a waterjet three times a day.
Treatment:
Device: Waterjet
Device: Manual Toothbrush
Electric TB+Floss
Experimental group
Description:
Cleaning teeth with an electric toothbrush and dental floss three times a day .
Treatment:
Device: Electric Toothbrush
Device: Dental floss
Electric TB +Waterjet
Experimental group
Description:
Cleaning teeth with an electric toothbrush and a waterjet three times a day .
Treatment:
Device: Electric Toothbrush
Device: Waterjet

Trial contacts and locations

1

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Central trial contact

Omar H AlKadhi, BDS, MSc

Data sourced from clinicaltrials.gov

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