Clinical Trial Qualifications: Regeneration of Pulp Dentin Development
Participant has a permanent tooth with a necrotic pulp (as defined by lack of responsiveness to both electrical pulp tests and cold [EndoIce] tests). If the tooth was traumatized, then pulpal necrosis is defined as either: 1) no response to both electrical pulp test and cold [EndoIce] test by three months after trauma, or 2) presence of a periapical lesion, or 3) radiographic evidence of root resorption, or 4) discoloration of the crown.
Tooth in question is restorable (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown.
Incomplete (i.e., immature) root development defined by apical foramen ≥1.0mm (each foramina >1.0mm for multi-rooted teeth).
At least 5 mm of root development (CEJ to radiographic apex).
Willing and able to provide informed assent/consent.
Legal guardian willing and able to provide informed consent.
No access to telephone for study contacts.
Unable to comprehend study materials in English or Spanish.
Subject not available for follow up at 12 or 24 months.
Previous allergic response to ciprofloxacin, metronidazole or minocycline or any materials used in the study.
History of systemic diseases with altered immune function including diabetes, immunodeficiency, leukemia, Addison's or Cushing's disease.
History of taking immunosuppressants or chemotherapeutic agents including glucocorticoids in the past 3 months.
Clinical or radiographic evidence of root fracture or alveolar fracture.
Tooth in question received prior endodontic obturation.
Tooth in question has class III mobility or dens invaginatus.
Tooth in question has a history of avulsion with extra-oral dry time longer than 1 hour.
Clinical judgement (with documentation of the reason)
Radiographic or clinical identification of ankylosis (replacement resorption) or inflammatory (infection-related) root resorption.
Call UT Dentistry’s Advanced Endodontic Clinic at 210-567-3355.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01976065.