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Measurement of Bite Force in Humans

This study has been completed.

Sponsored by: The University of Texas Health Science Center at San Antonio
Information provided by: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223327
  Purpose

This protocol is for a clinical trial to evaluate the reliability of the bite fork as a diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.


Condition Phase
Dental Pulp Necrosis
Periapical Periodontitis
Phase 0

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Measurement of Bite Force in Humans

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   89
Study Start Date:   March 2005
Study Completion Date:   June 2008
Primary Completion Date:   June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This clinical trial consists of two parts. We will first use the bite fork in normal volunteers to evaluate its test-retest and inter-rater reliability. We will then use the bite fork in subjects with differing endodontic diagnoses and compare these results with the standard clinical diagnostic test (percussion).

  Eligibility
Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample

Study Population

Normal subjects and patients with orofacial pain presenting in the dental clinic.


Criteria

Inclusion Criteria:

  1. Patient must be at least 16 years of age.
  2. Clinical indication for non-surgical root canal therapy (NSRCT).
  3. 1st or 2nd maxillary or mandibular molar or premolar
  4. Diagnosis must be chronic apical periodontitis (CAP) with or without symptoms.
  5. Intact, mature apices.
  6. American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria:

  1. Failure to meet any of the above
  2. Previous NSRCT
  3. Previous pulpotomy or pulpectomy
  4. Suppurative apical periodontitis
  5. Patients taking medications which can affect their pain rating or medications which affect their immune system (such as glucocorticoids)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223327

Locations
United States, Texas
University of Texas Health Science Center at San Antonio    
      San Antonio, Texas, United States, 78229-3900

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio

Investigators
Principal Investigator:     Asma A Khan     University of Texas Health Science Center at San Antonio, Texas    
  More Information


Responsible Party:   University of Texas Health Science Center San Antonio ( Asma Khan, DDS, PhD )
Study ID Numbers:   023-1904-101
First Received:   September 13, 2005
Last Updated:   July 18, 2008
ClinicalTrials.gov Identifier:   NCT00223327
Health Authority:   United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
pain  
Normal pulp and normal periodontal status  
Chronic apical periodontitis of pulpal origin  

Study placed in the following topic categories:
Mouth Diseases
Tooth Diseases
Periodontal Diseases
Necrosis
Dental Pulp Necrosis
Dental Pulp Diseases
Periodontitis
Periapical Diseases
Pain
Stomatognathic Diseases
Periapical Periodontitis

Additional relevant MeSH terms:
Pathologic Processes
Jaw Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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