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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole |
|
| Group B | Experimental | Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline |
|
| Group C | Active Comparator | Group C - Mineral trioxide aggregate: used as an apical barrier |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Antibiotic Paste | Drug | ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. |
| 3 measurements over 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcomes will be lack of clinical symptoms and crown staining. |
| assessed over the 6 month study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth M Hargreaves, DDS, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
No data to be shared
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| 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 |
|
| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C086631 | mineral trioxide aggregate |
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