Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
NCT ID: NCT01976065
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
125 participants
INTERVENTIONAL
2014-09-30
2018-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Mineral Trioxide Aggregate (MTA)
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).
Standard Treatment
Standard Treatment no use of study drug
Revascularization Treatment (REVASC)
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.
Triple Antibiotic Paste
USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency
Regeneration Treatment (REGENDO)
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.
Triple Antibiotic Paste
USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency
Interventions
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Triple Antibiotic Paste
USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency
Standard Treatment
Standard Treatment no use of study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
20 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Loma Linda University
OTHER
University of North Carolina
OTHER
American Association of Endodontists
OTHER
Kenneth Hargreaves
OTHER
Responsible Party
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Kenneth Hargreaves
Chair, Dept. of Endodontics, UTHSCSA
Principal Investigators
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Kenneth Hargreaves, DDS, PhD
Role: STUDY_CHAIR
University of Texas
Locations
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Loma Linda University
Loma Linda, California, United States
University of Maryland
Baltimore, Maryland, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Countries
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Other Identifiers
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HSC20130467H
Identifier Type: -
Identifier Source: org_study_id
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