Measurement of Bite Force in Humans

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT00223327

First received: September 13, 2005

Last updated: March 7, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

March 7, 2012

Start Date ^ICMJE

March 2005

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00223327 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Measurement of Bite Force in Humans

Official Title ^ICMJE

Measurement of Bite Force in Humans

Brief 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.

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).

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Dental Pulp Necrosis
Periapical Periodontitis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Failure to meet any of the above
Previous NSRCT
Previous pulpotomy or pulpectomy
Suppurative apical periodontitis
Patients taking medications which can affect their pain rating or medications which affect their immune system (such as glucocorticoids)

Gender

Both

Ages

16 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00223327

Other Study ID Numbers ^ICMJE

023-1904-101

Has Data Monitoring Committee

Responsible Party

The University of Texas Health Science Center at San Antonio

Study Sponsor ^ICMJE

The University of Texas Health Science Center at San Antonio

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Asma A Khan

University of Texas Health Science Center at San Antonio, Texas

Information Provided By

The University of Texas Health Science Center at San Antonio

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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