Oral Hygiene in Patients With Orthodontic Fixed Appliances

Oral Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789812
• Other study ID #: REU/Proposal2018
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: December 2018
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: Omar H Alkadhi
• Phone: 966505154754
• Email: omar.alkadhi[@]riyadh.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 15, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Hygiene

Intervention

Device:
• Manual toothbrush
Soft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces.
• Electric Toothbrush
Electric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces.
• Superfloss
Superfloss (Oral B) will be used to clean interproximal teeth surfaces.
• Dental Water Jet
Dental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces.

Locations

Country	Name	City	State
Saudi Arabia	Omar AlKadhi	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plaque index	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
Primary	Change in gingival index	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