Oral Hygiene in Patients With Orthodontic Fixed Appliances

NCT03789812 | Unknown

• 1 other identifier: REU/Proposal2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

Manual Toothbrush with Superfloss

ACTIVE COMPARATOR

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; Device: Superfloss

Electric Toothbrush with Superfloss

EXPERIMENTAL

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; Device: Superfloss

Manual Toothbrush with Water Flosser

EXPERIMENTAL

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; Device: Dental Water Jet

Electric Toothbrush with Water Flosser

EXPERIMENTAL

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; Device: Dental Water Jet

Interventions

Manual toothbrush DEVICE

Soft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces.

Manual Toothbrush with Superfloss; Manual Toothbrush with Water Flosser

Electric Toothbrush DEVICE

Electric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces.

Electric Toothbrush with Superfloss; Electric Toothbrush with Water Flosser

Superfloss DEVICE

Superfloss (Oral B) will be used to clean interproximal teeth surfaces.

Electric Toothbrush with Superfloss; Manual Toothbrush with Superfloss

Dental Water Jet DEVICE

Dental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces.

Electric Toothbrush with Water Flosser; Manual Toothbrush with Water Flosser

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• patients with mental retardation.
• patients with systematic diseases.

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Omar AlKadhi

Riyadh, 11372, Saudi Arabia

RECRUITING

Central Study Contacts

Omar H Alkadhi

CONTACT

966505154754; omar.alkadhi@riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 31, 2018
• Study Start: December 3, 2018
• Primary Completion: May 30, 2019
• Study Completion: July 15, 2019
• Last Updated: December 31, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)