Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kenneth Hargreaves
• Collaborators: American Association of Endodontists; Loma Linda University; University of Maryland; University of Maryland, College Park; University of North Carolina
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Bacitracin; Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination; Ciprofloxacin; Metronidazole; Minocycline; Neomycin; Polymyxin B

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.