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The purpose of the investigators study is to characterize the composition of the hard and soft tissues present in root canals of teeth previously diagnosed with necrotic pulps and incomplete root formation and treated with a triple antibiotic regeneration protocol. The investigators hypothesis is that treatment of teeth with necrotic pulps and immature apices with triple antibiotic paste will stimulate continued root formation by the deposition of dentin at the root apices. The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth.
'Regeneration' as referred to in this protocol refers to the stimulation of continued root formation by the deposition of apical tissues subsequent to disinfection of a necrotic root canal and its contents and creation of a scaffold upon which cells can proliferate. While the proposed treatment protocol is currently being used in clinical practice and has been shown to be successful in case reports and case series, the nature of the proliferating apical tissues remains unknown. Thus, this study is uniquely positioned to address a critical gap in knowledge in the regeneration of a functional pulp-dentin complex. Moreover, results obtained from pediatric cases may well provide the essential foundation of knowledge for endodontists to apply this knowledge to the more difficult situation of regenerating the pulp-dentin complex of the full mature permanent tooth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A subjects will be asked to attend a recall visit 2 months following completion of the treatment visits. |
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| Group B | Experimental | Group B subjects will be asked to attend a recall visit at 4 months following completion of the treatment visits. |
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| Group C | Experimental | Group C subjects will be asked to attend a recall visit at 6 months following completion of the treatment visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple Antibiotic Paste | Drug | ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation. |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth. | three year |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome measure will be conducted by measuring markers of stem cells prior to and after the formation of the blood clot. | three year |
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Inclusion Criteria:
Patient Inclusion Criteria:
Tooth inclusion criteria:
Exclusion Criteria:
Patient Exclusion Criteria:
Tooth Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth M Hargreaves, DDS,PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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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 and cell proliferation. |
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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 and cell proliferation. |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |