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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pulp Necrosis
Drug: Double Antibiotic Paste
Drug: Triple Antibiotic Paste
Drug: Mineral Trioxide Aggregate
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]
    1. st radiograph taken at 1 month post-procedure completion
    2. nd radiograph taken at 3 month post-procedure completion
    3. rd radiograph taken at 6 month post-procedure completion


Secondary Outcome Measures:
  • 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 ]
    1. st clinical assessment done at 1 month post-procedure completion
    2. nd clinical assessment done at 3 month post-procedure completion
    3. rd clinical assessment done at 6 month post-procedure completion


Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole
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
Experimental: Group B
Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline
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
Active Comparator: Group C
Group C - Mineral trioxide aggregate: used as an apical barrier
Drug: Mineral Trioxide Aggregate
standard material providing an apical barrier
Other Name: Mineral Trioxide Aggregate

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.

  Eligibility

Ages Eligible for Study:   7 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881491

Contacts
Contact: Erin Locke, RN 210-567-0895 locke@uthscsa.edu

Locations
United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Lola Miranda    210-567-0873    MirandaM4@uthscsa.edu   
Principal Investigator: Kenneth M Hargreaves, DDS, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Kenneth M Hargreaves, DDS, PhD The University of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: Kenneth Hargreaves, Chair, Department of Endodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00881491     History of Changes
Other Study ID Numbers: HSC20090181H
Study First Received: April 13, 2009
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
Regeneration (revascularization) of dental pulp
Immature permanent tooth with a diagnosis of

Additional relevant MeSH terms:
Dental Pulp Necrosis
Dental Pulp Diseases
Necrosis
Tooth Diseases
Stomatognathic Diseases
Pathologic Processes
Anti-Bacterial Agents
Ciprofloxacin
Bacitracin
Neomycin
Polymyxin B
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Anti-Infective Agents, Local
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014