Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
- Conditions
- Pulp Necrosis
- Interventions
- Registration Number
- NCT00881491
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C Mineral Trioxide Aggregate Group C - Mineral trioxide aggregate: used as an apical barrier Group A Double Antibiotic Paste Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole Group B Triple Antibiotic Paste Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline
- Primary Outcome Measures
Name Time Method The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. 3 measurements over 6 months 1. st radiograph taken at 1 month post-procedure completion
2. nd radiograph taken at 3 month post-procedure completion
3. rd radiograph taken at 6 month post-procedure completion
- Secondary Outcome Measures
Name Time Method The secondary outcomes will be lack of clinical symptoms and crown staining. assessed over the 6 month study period 1. st clinical assessment done at 1 month post-procedure completion
2. nd clinical assessment done at 3 month post-procedure completion
3. rd clinical assessment done at 6 month post-procedure completion
Trial Locations
- Locations (1)
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States