Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots (NCT01976065) | Clinical Trial Compass
CompletedPhase 1
Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
United States125 participantsStarted 2014-09
Plain-language summary
This multi-center exploratory clinical trial is a randomized trial designed to test whether a regenerative endodontic procedure using tissue engineering principles (REGENDO), or a revascularization (REVASC) endodontic procedure, in comparison to standard apexification treatment using a mineral trioxide aggregate barrier (apexification; APEX), produces a significantly better composite clinical outcome for the treatment of immature permanent teeth with pulpal necrosis.
Who can participate
Age range6 Years – 20 Years
SexALL
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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.
* …