Pulp Necrosis
Conditions
Keywords
Regeneration (revascularization) of dental pulp, Immature permanent tooth with a diagnosis of
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.
Interventions
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
DRUGMineral Trioxide Aggregate
standard material providing an apical barrier
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed