Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
Pulp Necrosis, Regeneration
About this trial
This is an interventional treatment trial for Pulp Necrosis focused on measuring Necrotic tooth pulp, Immature permanent teeth, Regeneration
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Loma Linda University
- University of Maryland
- University of North Carolina
- University of Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Experimental
Experimental
Mineral Trioxide Aggregate (MTA)
Revascularization Treatment (REVASC)
Regeneration Treatment (REGENDO)
Standard Treatment group consisting of placement of Mineral Trioxide Aggregate (MTA), an FDA approved dental material at the end of an immature root followed by a composite restoration (crown).
Consists of standard treatment procedure PLUS disinfection of the canal space with Triple Antibiotic Paste study medication followed by placement of Collaplug, an FDA approved material to help promote clotting. A composite restoration in then placed.
Consists of standard treatment procedure PLUS Triple Antibiotic Paste study medication PLUS use of Emdogain, an FDA approved medication used in an FDA approved manner, that is a growth factor to help surrounding tissues to grow together and heal.