NCT00223379

Brief Summary

This protocol is for a clinical trial evaluating the clinical success of root canal therapy performed on teeth with chronic apical periodontitis of pulpal origin with either large or small apical root canal preparation techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

5 years

First QC Date

September 13, 2005

Last Update Submit

March 6, 2012

Conditions

Chronic Apical Periodontitis of Pulpal Origin

Keywords

Apical Periodontitis, Root Canal Therapy, Apical Preparation

Outcome Measures

Primary Outcomes (1)

  • Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin.

    2 year

Secondary Outcomes (1)

  • Pain

    2 years

Interventions

Endodontic procedure with varied apical preparation sizePROCEDURE

Comparison of two commonly used techniques for performing root canal treatment: 1) Lightspeed method 2)Buchannan method

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be at least 18 years of age.
  • Clinical indication for Non-Surgical Root Canal Therapy (NSRCT).
  • st or 2nd maxillary or mandibular molar.
  • Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms.
  • Intact, mature apices.
  • ASA I or II.

You may not qualify if:

  • Failure to meet any of the above
  • Previous NSRCT
  • Previous pulpotomy or pulpectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Endodontics

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Karl Keiser, DDS, MS

    The University of Texas Health Science Center at San Antonio, Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Dept. of Endodontics

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

December 1, 2002

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(1)