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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulp Necrosis

Intervention / Treatment
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* Drug: Double Antibiotic Paste
* Drug: Triple Antibiotic Paste
* Drug: Mineral Trioxide Aggregate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole | Drug: Double Antibiotic Paste<br>* ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.<br>|
| Experimental: Group B<br>Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline | Drug: Triple Antibiotic Paste<br>* ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.<br>|
| Active Comparator: Group C<br>Group C - Mineral trioxide aggregate: used as an apical barrier | Drug: Mineral Trioxide Aggregate<br>* standard material providing an apical barrier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. | 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 | 3 measurements over 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcomes will be lack of clinical symptoms and crown staining. | 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 | assessed over the 6 month study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regeneration (revascularization) of dental pulp, Immature permanent tooth with a diagnosis of