Clinical trial NCT00881491: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pulp Necrosis
Keywords: Regeneration (revascularization) of dental pulp
Immature permanent tooth with a diagnosis of
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2009-04-15
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.
timeFrame: 3 measurements over 6 months
Secondary outcomes:
measure: The secondary outcomes will be lack of clinical symptoms and crown staining.
timeFrame: assessed over the 6 month study period
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Kenneth M Hargreaves, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: