NCT01332760

Brief Summary

Dentists and dental hygienists experience elevated rates of musculoskeletal disorders, such as carpal tunnel syndrome and tendonitis, primarily due to the high pinch force required for dental scaling. There is evidence that a lighter and larger diameter tool can significantly reduce the pinch force. This randomized controlled study will determine if dentists or dental hygienists who use such a tool report less hand and arm pain compared to those who continue to use the conventional tool design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration 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

April 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

1.9 years

First QC Date

April 6, 2011

Last Update Submit

February 21, 2012

Conditions

Keywords

ergonomicsworkplaceoccupationaltooldentaldentist

Outcome Measures

Primary Outcomes (3)

  • change from baseline in right shoulder pain score at 4 months

    peak pain assessed on 0-10 scale using end of week questionnaire

    4 months after intervention

  • Change from baseline in right elbow pain at 4 months

    peak pain assessed on 0-10 scale using end of week questionnaire

    4 months after intervention

  • change from baseline in right wrist pain at 4 months

    peak pain assessed on 0-10 scale using end of week questionnaire

    4 months after intervention

Secondary Outcomes (2)

  • change in pain medication usage

    pre-intervention compared to post intervention

  • change in nights per week waken from sleep due to finger numbness

    pre-intervention compared to post intervention

Study Arms (2)

narrow diameter heavy dental tool

ACTIVE COMPARATOR

periodontal tools for dental scaling and cleaning provided that have a narrow diameter (8mm) made of heavy material (steel).

Other: narrow diameter heavy dental tool

light large diameter dental tool

EXPERIMENTAL

periodontal tools for scaling and tooth cleaning provided with large diameter (11mm) handle made of light weight material

Other: large diameter light weight tool

Interventions

8mm diameter, heavy periodontal tool made from steel

Also known as: traditional tool
narrow diameter heavy dental tool

Periodontal tools (4-8) provided to dental practitioners to use for all dental scaling or cleaning. This tool handle diameter is 11 mm diameter and it is made from lightweight Delrin.

Also known as: intervention tool
light large diameter dental tool

Eligibility Criteria

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

You may qualify if:

  • dentists and dental hygienists from the San Francisco Bay Area
  • dental practitioners who perform more than 10 hours of dental hygiene work per week
  • dental practitioners who have been performing dental hygiene work for more than 1 year

You may not qualify if:

  • not currently under a physician's care for treatment of an upper extremity disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Ergonomics Program

Richmond, California, 94804, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Rempel, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 11, 2011

Study Start

April 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations