NCT02951065

Brief Summary

This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush. Subjects are recruited from patients attending the Western University of Health Sciences Dental Center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. The exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

October 27, 2016

Last Update Submit

May 8, 2017

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)

    Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.

    About 1 year

Secondary Outcomes (3)

  • Plaque level

    About 1 year

  • Gingival bleeding on probing

    About 1 year

  • Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)

    About 1 year

Study Arms (2)

Bristle-less brush

EXPERIMENTAL

Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily

Other: Tooth brush without nylon bristles

Soft bristle brush

ACTIVE COMPARATOR

Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily

Other: Tooth brush with soft nylon bristles

Interventions

Tooth brush without nylon bristlesOTHER

Subjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months

Also known as: PeriClean Toothbrush
Bristle-less brush
Tooth brush with soft nylon bristlesOTHER

Subjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months

Also known as: Oral B soft brush
Soft bristle brush

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • receive regular periodontal treatment at the Western University of Health Sciences Dental Center
  • have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths

You may not qualify if:

  • unable to provide consent
  • had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3
  • acute pain or infection
  • caries near the gingival margin
  • restorations covering the gingival recession defect
  • presence of Miller Class III or IV defects
  • severe or aggressive periodontitis
  • missing more than one anterior tooth
  • severe malocclusion
  • presence of occlusal trauma requiring more than limited adjustment
  • Tobacco use
  • ongoing or planned orthodontic therapy
  • oral piercings
  • history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits
  • preferred use of an electric tooth brush over a manual brush

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival Recession

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 1, 2016

Study Start

March 1, 2015

Primary Completion

February 15, 2017

Study Completion

April 10, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share