Oral Hygiene in Patients With Orthodontic Fixed Appliances

December 27, 2018 updated by: Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy

Efficacy of Different Methods of Teeth Cleaning on Oral Hygiene in Patients With Orthodontic Fixed Appliances

The study aims to compare the efficacy of the use of different methods of teeth cleaning on the oral hygiene in patients with orthodontic fixed appliance

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Subjects were randomized into four groups, the first group will receive manual tooth brush with super floss, the second group will receive electric tooth brush with super floss, the third group will receive manual tooth brush with water dental flosser and the fourth group will receive electric tooth brush with water flosser.

Study Type

Interventional

Enrollment (Anticipated)

100

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

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Manual Toothbrush with Superfloss
Patients in this group will receive Manual Toothbrush (Oral B) and Superfloss (Oral B) and will be instructed to use them three times a day.
Device: Manual toothbrush
Soft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces.
Device: Superfloss
Superfloss (Oral B) will be used to clean interproximal teeth surfaces.
Experimental: Electric Toothbrush with Superfloss
Patients in this group will receive Electric Toothbrush (JETPIK) and Superfloss (Oral B) and will be instructed to use them three times a day.
Device: Superfloss
Superfloss (Oral B) will be used to clean interproximal teeth surfaces.
Device: Electric Toothbrush
Electric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces.
Experimental: Manual Toothbrush with Water Flosser
Patient in this group will receive Manual Toothbrush and Dental Water Jet and will be instructed to use them three times a day.
Device: Manual toothbrush
Soft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces.
Device: Dental Water Jet
Dental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces.
Experimental: Electric Toothbrush with Water Flosser
Patient in this group will receive Electric tooth brush (JETPIK) and water flosser and will be instructed to use them three times a day.
Device: Electric Toothbrush
Electric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces.
Device: Dental Water Jet
Dental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plaque index
Time Frame: baseline, after 4 weeks and after 8 weeks
plaque index: 0 no plaque, 1 plaque seen only on tip of explorer or with disclosing agents, 2 plaque seen with naked eye, 3 abundance of plaque
baseline, after 4 weeks and after 8 weeks
Change in gingival index
Time Frame: baseline, after 4 weeks and after 8 weeks
gingival index: 0, normal gingiva, 1 mild inflammation- slight change in color, slight edema and bleeding on probing. 2 moderate inflammation - redness, edema and bleeding on probing. 3, sever inflammation - redness, edema, and tendency to spontaneous bleeding
baseline, after 4 weeks and after 8 weeks

Collaborators and Investigators

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

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

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)

December 3, 2018

Primary Completion (Anticipated)

May 30, 2019

Study Completion (Anticipated)

July 15, 2019

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

December 27, 2018

First Posted (Actual)

December 31, 2018

Study Record Updates

Last Update Posted (Actual)

December 31, 2018

Last Update Submitted That Met QC Criteria

December 27, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • REU/Proposal2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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