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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

April 13, 2009
August 11, 2014
April 2009
June 2016   (final data collection date for primary outcome measure)
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
The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00881491 on ClinicalTrials.gov Archive Site
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
The secondary outcomes will be lack of clinical symptoms and crown staining. [ Time Frame: one year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulp Necrosis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
7 Years to 60 Years
Yes
Contact: Erin Locke, RN 210-567-0895 locke@uthscsa.edu
United States
 
NCT00881491
HSC20090181H
Yes
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
Not Provided
Principal Investigator: Kenneth M Hargreaves, DDS, PhD The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
August 2014

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