Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

This study is currently recruiting participants.

Verified April 2013 by The University of Texas Health Science Center at San Antonio

Sponsor:

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT00881491

First received: April 13, 2009

Last updated: April 5, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 13, 2009

Last Updated Date

April 5, 2013

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. [ Time Frame: 3 measurements over 6 months ] [ Designated as safety issue: No ]

st radiograph taken at 1 month post-procedure completion
nd radiograph taken at 3 month post-procedure completion
rd radiograph taken at 6 month post-procedure completion

Original Primary Outcome Measures ^ICMJE

The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. [ Time Frame: one year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00881491 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The secondary outcomes will be lack of clinical symptoms and crown staining. [ Time Frame: assessed over the 6 month study period ] [ Designated as safety issue: No ]

st clinical assessment done at 1 month post-procedure completion
nd clinical assessment done at 3 month post-procedure completion
rd clinical assessment done at 6 month post-procedure completion

Original Secondary Outcome Measures ^ICMJE

The secondary outcomes will be lack of clinical symptoms and crown staining. [ Time Frame: one year ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

Official Title ^ICMJE

Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

Brief Summary

The purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide aggregate (MTA) apexification treatment.

Detailed Description

Recent case series have reported positive outcomes treating necrotic immature permanent teeth with a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline). However, this method can result in considerable staining due to minocycline. In this randomized clinical trial, we will compare clinical outcomes of a triple antibiotic paste versus a double antibiotic paste (ciprofloxacin, metronidazole) intracanal medicament as compared to a standard treatment (immediate apexification with MTA) in permanent teeth with necrotic pulps and immature root development. We hypothesize there will be no significant differences between radiographic measures of root development after treatment with either the double versus triple antibiotic paste, and that both methods will produce significantly greater increases in root length and width compared to standard treatment. The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness and the secondary outcomes will be lack of clinical symptoms and crown staining.

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pulp Necrosis

Intervention ^ICMJE

Drug: Double Antibiotic Paste
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.

Other Name: Double Antibiotic Paste
Drug: Triple Antibiotic Paste
ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.

Other Name: Triple Antibiotic Paste
Drug: Mineral Trioxide Aggregate
standard material providing an apical barrier

Other Name: Mineral Trioxide Aggregate

Study Arm (s)

Experimental: Group A
Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole

Intervention: Drug: Double Antibiotic Paste
Experimental: Group B
Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline

Intervention: Drug: Triple Antibiotic Paste
Active Comparator: Group C
Group C - Mineral trioxide aggregate: used as an apical barrier

Intervention: Drug: Mineral Trioxide Aggregate

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

diagnosis of pulpal necrosis with apical periodontitis
patients 7-60 years of age
maxillary or mandibular restorable single rooted immature permanent tooth with open apices
acceptance of treatment plan with revascularization procedure
healthy patient (ASA Class I or II physical status) with no systemic health problems

Exclusion Criteria:

non-restorable teeth
patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report to be a carrier of HIV, undergoing steroid therapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response.
child subjects unable to give assent

Gender

Both

Ages

7 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Erin Locke, RN

210-567-0895

locke@uthscsa.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00881491

Other Study ID Numbers ^ICMJE

HSC20090181H

Has Data Monitoring Committee

Yes

Responsible Party

Kenneth Hargreaves, 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:

Kenneth M Hargreaves, DDS, PhD

University of Texas Health Science Center at San Antonio

Information Provided By

The University of Texas Health Science Center at San Antonio

Verification Date

April 2013

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

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