NCT00010972

Brief Summary

This study is testing the safety and effectiveness of acupuncture in controlling pain related to the removal of partially impacted mandibular third molars. Acupuncture is the Chinese art of healing by inserting needles into the skin. Participants ages 18 - 40 are given an initial x-ray to determine if one lower molar is partially bony impacted. Eligible participants will then undergo standard oral surgery to remove the impacted molar. A local anesthetic will be used prior to surgery. Directly after surgery the participant will be assigned to one of three groups. Participants will not be able to select which group they are assigned. Participants will receive either real or sham (fake) acupuncture as a treatment for post-extraction pain. After the initial acupuncture treatment, participants are required to remain for six hours at the dental site to be monitored. If a participants discomfort is measured as moderate or higher then a second acupuncture treatment will be administered. All participants will be administered questionnaires during the day of surgery. Participants will also be required to complete two diaries during the seven days following surgery. On the seventh day, participants return to have stitches removed and hand in completed diaries.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2001

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

February 2, 2001

Last Update Submit

August 17, 2006

Conditions

Tooth, Impacted

Interventions

AcupuncturePROCEDURE

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • At least one lower mandibular molar with partial bony impaction
  • General good health
  • Minimum body weight of 99 lbs.
  • Able to read and write in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rivers Center Dental Associates

Columbia, Maryland, 21046, United States

Location

MeSH Terms

Conditions

Tooth, Impacted

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Sharon Nelson

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 5, 2001

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)