NCT04254770

Brief Summary

The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. This study, therefore, will specifically include and document that a subject exhibits periodontitis upon study entry, and measure the ensuing response following professional treatment of scaling and root planing, followed by home use of the assigned study products (powered or manual toothbrushing).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

January 29, 2020

Last Update Submit

January 24, 2022

Conditions

PeriodontitisDental Plaque

Outcome Measures

Primary Outcomes (1)

  • Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.

    6 months

Secondary Outcomes (3)

  • Change in supragingival plaque, as measured by Modified Plaque Index

    6 months

  • Change in clinical attachment level

    6 months

  • Change in periodontitis, as measured by probing pocket depth

    6 months

Study Arms (2)

ADA (American Dental Association) approved Manual Toothbrush

ACTIVE COMPARATOR
Device: ADA approved Manual Toothbrush

Marketed Power Toothbrush

EXPERIMENTAL
Device: Marketed Power Toothbrush

Interventions

ADA approved Manual ToothbrushDEVICE

ADA approved Manual Toothbrush

ADA (American Dental Association) approved Manual Toothbrush
Marketed Power ToothbrushDEVICE

Marketed Power Toothbrush

Marketed Power Toothbrush

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18-75 years
  • Exhibiting Stage I or II periodontitis
  • Minimum of 20 'scorable' teeth (excluding 3rd molars)
  • Regular manual toothbrush user
  • Have a minimum average plaque score of \> 1.8 per Modified Plaque Index scoring with 3-6 hours plaque accumulation
  • Agree to desist use of interproximal cleaning aids and other prohibited devices or medicaments during the study period
  • Be a non-smoker (\> 10 years), or never smoker

You may not qualify if:

  • Have a cardiac pacemaker or implanted cardiac defibrillator
  • Have uncontrolled Insulin-Dependent Diabetes Have current use of antibiotic medications or use within 4 weeks of enrollment
  • Have current use of prescription-dose anti-inflammatory medications or anticoagulants Have excessive gingival recession, per Investigator/Examiner discretion
  • Have heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
  • Have had a professional prophylaxis within 4 weeks of the study
  • Prior chemotherapy, immunotherapy or radiation therapy within last 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salus Research, Inc

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (1)

  • Jenkins W, Starke EM, Nelson M, Milleman K, Milleman J, Ward M. The effects of scaling and root planing plus home oral hygiene maintenance in Stage I/II periodontitis population: A 24-week randomized clinical trial. Int J Dent Hyg. 2024 Aug;22(3):727-735. doi: 10.1111/idh.12783. Epub 2024 Jan 30.

    PMID: 38289823DERIVED

MeSH Terms

Conditions

PeriodontitisDental Plaque

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Design

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

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 5, 2020

Study Start

January 6, 2020

Primary Completion

August 10, 2020

Study Completion

August 10, 2020

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)