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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00223327
Other study ID # 023-1904-101
Secondary ID
Status Completed
Phase Phase 0
First received September 13, 2005
Last updated March 7, 2012
Start date March 2005
Est. completion date June 2008

Study information

Verified date March 2012
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years to 60 Years
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States University of Texas Health Science Center at San Antonio San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

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