Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Hygiene in Patients With Orthodontic Fixed Appliances

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789812
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Oral Hygiene Device: Manual toothbrush Device: Electric Toothbrush Device: Superfloss Device: Dental Water Jet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Different Methods of Teeth Cleaning on Oral Hygiene in Patients With Orthodontic Fixed Appliances
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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: Electric Toothbrush
Electric toothbrush (Jetpik JP210) 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: 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.




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789812


Contacts
Layout table for location contacts
Contact: Omar H Alkadhi 966505154754 omar.alkadhi@riyadh.edu.sa

Locations
Layout table for location information
Saudi Arabia
Omar AlKadhi Recruiting
Riyadh, Saudi Arabia, 11372
Contact: Omar AlKadhi, BDS, MS    505154754    omar.alkadhi@riyadh.edu.sa   
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy

Layout table for additonal information
Responsible Party: Omar Alkadhi, Assistant professor, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT03789812     History of Changes
Other Study ID Numbers: REU/Proposal2018
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No