Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health.

NCT04003298 | Completed FDA Device

• 1 other identifier: 26ORWF2019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally plaque removal will be evaluated after a single use and over 4 weeks.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (2)

• Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.

  Bleeding on Probing

  4 weeks

• Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks

  Modified Gingival Index

  4 weeks

Secondary Outcomes (1)

• Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks.

  pre & post, 4 weeks

Study Arms (2)

Electric toothbrush and power interdental device

EXPERIMENTAL

Electric toothbrush and power interdental device

Device: Electric toothbrush

Electric toothbrush

ACTIVE COMPARATOR

Electric toothbrush

Device: Control

Interventions

Electric toothbrush DEVICE

Electric toothbrush and power interdental device

Electric toothbrush and power interdental device

Control DEVICE

Oscillating-rotating

Electric toothbrush

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 20 and 70 years of age
• Be able to provide written informed consent prior to participation
• Agree to not participate in any other oral/dental products clinical study for the study duration
• Be in good general health and be a non-smoker
• Have 50% bleeding on probing sites (moderate gingivitis)
• Have no probing depths greater than 4 mm
• Have a minimum of 20 teeth (not including 3rd molars)
• No partial dentures, orthodontic brackets, wires or other appliances
• Agree to refrain from the use of any non-study dental device or oral care product for the study duration
• Agree to return for the scheduled visits and follow study procedures
• Agree to delay dental prophylaxis until study completion
• Have a minimum pre-brushing plaque score of 0.6
• Have a minimum of 1.75 gingivitis score

You may not qualify if:

• Have probing depth greater than 4 mm
• Have a systemic disease (ex. Diabetes, autoimmune disease)
• Have advanced periodontitis
• Taking medication that can influence gingival health (ex. Dilantin, Procardia (calcium channel blockers), Cyclosporine, anticoagulants)
• Have orthodontic appliances or removable partial dentures
• Pregnant at time of study
• Use of antibiotics within 6 months of study

Sponsors & Collaborators

• Water Pik, Inc.: lead
• All Sum Research Center Ltd.: collaborator

Study Sites (1)

All Sum Research Center Ltd.

Mississauga, Ontario, L5N 6J2, Canada

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jimmy Qaqish

  All Sum Research Center Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 1, 2019
• Study Start: June 26, 2019
• Primary Completion: July 26, 2019
• Study Completion: August 23, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)