Clinical Trial Qualifications: Regeneration of Pulp Dentin Development
- Age 6-20
- 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.