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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Pulp Necrosis

Treatments: Drug: Mineral Trioxide Aggregate; Drug: Double Antibiotic Paste; Drug: Triple Antibiotic Paste

Study type: Interventional

Funder types: Other

Identifiers

NCT00881491

HSC20090181H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 7 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: Double Antibiotic Paste

Group B

Experimental group

Description:

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

Treatment:

Drug: Triple Antibiotic Paste

Group C

Active Comparator group

Description:

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

Treatment:

Drug: Mineral Trioxide Aggregate