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

Primary Purpose

Pulp Necrosis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Double Antibiotic Paste
Triple Antibiotic Paste
Mineral Trioxide Aggregate
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necrosis focused on measuring Regeneration (revascularization) of dental pulp, Immature permanent tooth with a diagnosis of

Eligibility Criteria

7 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

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

Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline

Group C - Mineral trioxide aggregate: used as an apical barrier

Outcomes

Primary Outcome Measures

The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.
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

Secondary Outcome Measures

The secondary outcomes will be lack of clinical symptoms and crown staining.
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

Full Information

First Posted
April 13, 2009
Last Updated
February 4, 2016
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT00881491
Brief Title
Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
Official Title
Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necrosis
Keywords
Regeneration (revascularization) of dental pulp, Immature permanent tooth with a diagnosis of

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Group C - Mineral trioxide aggregate: used as an apical barrier
Intervention Type
Drug
Intervention Name(s)
Double Antibiotic Paste
Intervention Description
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
Intervention Type
Drug
Intervention Name(s)
Triple Antibiotic Paste
Intervention Description
ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
Intervention Type
Drug
Intervention Name(s)
Mineral Trioxide Aggregate
Intervention Description
standard material providing an apical barrier
Primary Outcome Measure Information:
Title
The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.
Description
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
Time Frame
3 measurements over 6 months
Secondary Outcome Measure Information:
Title
The secondary outcomes will be lack of clinical symptoms and crown staining.
Description
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
Time Frame
assessed over the 6 month study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Hargreaves, DDS, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data to be shared

Learn more about this trial

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

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