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.

Study Overview

• Status: Completed
• Conditions: Pulp Necrosis
• Intervention / Treatment: Drug: Double Antibiotic Paste; Drug: Triple Antibiotic Paste; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.
Active Comparator: Group C; Group C - Mineral trioxide aggregate: used as an apical barrier	Drug: Mineral Trioxide Aggregate; standard material providing an apical barrier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 measurements over 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	assessed over the 6 month study period

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 13, 2009
• First Submitted That Met QC Criteria: April 14, 2009
• First Posted (Estimate): April 15, 2009

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Regeneration (revascularization) of dental pulp; Immature permanent tooth with a diagnosis of
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Necrosis; Dental Pulp Necrosis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: HSC20090181H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No data to be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No