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

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ClinicalTrials.gov Identifier: NCT00881491
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE April 13, 2009
First Posted Date  ICMJE April 15, 2009
Last Update Posted Date February 5, 2016
Study Start Date  ICMJE April 2009
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. [ Time Frame: 3 measurements over 6 months ]
  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
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
The secondary outcomes will be lack of clinical symptoms and crown staining. [ Time Frame: assessed over the 6 month study period ]
  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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
The secondary outcomes will be lack of clinical symptoms and crown staining. [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
  • Drug: Triple Antibiotic Paste
    ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
  • Drug: Mineral Trioxide Aggregate
    standard material providing an apical barrier
Study Arms  ICMJE
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2015)
10
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2009)
60
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00881491
Other Study ID Numbers  ICMJE HSC20090181H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No data to be shared
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 The University of Texas Health Science Center at San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date February 2016

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