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OpenTrials
Completed

NCT Number: NCT00881491

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.

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Key information

Age range

7 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double Antibiotic Paste

Drug

ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.

Triple Antibiotic paste

Drug

ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.

Mineral Trioxide Aggregate

Drug

standard material providing an apical barrier

Primary outcomes

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

    Time frame: 3 measurements over 6 months

    • 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 outcomes

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

    Time frame: assessed over the 6 month study period

    • 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2009
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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