Oral Hygiene in Patients With Orthodontic Fixed Appliances

NCT ID: NCT03789812

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Hygiene

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Manual toothbrush

Intervention Type DEVICE

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

Superfloss

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Electric Toothbrush

Intervention Type DEVICE

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

Superfloss

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Manual toothbrush

Intervention Type DEVICE

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

Dental Water Jet

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Electric Toothbrush

Intervention Type DEVICE

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

Dental Water Jet

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manual toothbrush

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

Intervention Type DEVICE

Electric Toothbrush

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

Intervention Type DEVICE

Superfloss

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

Intervention Type DEVICE

Dental Water Jet

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Omar Alkadhi

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Omar AlKadhi

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Omar H Alkadhi

Role: CONTACT

Phone: 966505154754

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Omar AlKadhi, BDS, MS

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REU/Proposal2018

Identifier Type: -

Identifier Source: org_study_id