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Use of Acupuncture for Dental Pain: Testing a Model

Primary Purpose

Tooth, Impacted

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Impacted

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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

Sites / Locations

  • Rivers Center Dental Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00010972
Brief Title
Use of Acupuncture for Dental Pain: Testing a Model
Official Title
Use of Acupuncture for Dental Pain: Testing a Model
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Nelson
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rivers Center Dental Associates
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21046
Country
United States

12. IPD Sharing Statement

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Use of Acupuncture for Dental Pain: Testing a Model

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