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

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ClinicalTrials.gov Identifier: NCT01976065
Recruitment Status : Active, not recruiting
First Posted : November 5, 2013
Last Update Posted : October 3, 2018
Sponsor:
Collaborators:
University of Maryland
Loma Linda University
University of North Carolina
American Association of Endodontists
Information provided by (Responsible Party):
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease Intervention/treatment Phase
Pulp Necrosis Regeneration Drug: Triple Antibiotic Paste Other: Standard Treatment Phase 1

Detailed Description:
This is a multi-center randomized clinical trial designed to test whether a regenerative endodontic procedure using tissue engineering principles (REGENDO), or a revascularization (REVASC) endodontic procedure, when compared to the standard apexification treatment using mineral trioxide aggregate barrier-MTA apexification (APEX), produces a significantly better composite clinical outcome for the treatment of immature permanent teeth with pulpal necrosis. This study will use an antibiotic mixture called Triple Antibiotic Paste (TAP), consisting of ciprofloxacin, metronidazole and minocycline, in the tooth for disinfection of the root canal in study arms REGENDO and REVASC. The FDA has issued an Investigational New Drug (IND) number allowing use of the triple antibiotic mixture in this trial. Other dental materials used in this study have already been FDA approved for use in humans to provide a matrix for the promotion of tissue growth in the root canal space. The study will also attempt to identify the type of bacteria within the root canal space and surrounding tissues by analyzing a small sample collected on a cotton-tip applicator. This clinical trial hopes to determine which of the three treatment methods helps the tooth to grow stronger and survive for at least two years after treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
Actual Study Start Date : September 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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).
Other: Standard Treatment
Standard Treatment no use of study drug
Other Name: No use of study drug

Experimental: 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.
Drug: 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
Other Name: Ciprofloxacin, Metronidazole, & Minocycline

Experimental: 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.
Drug: 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
Other Name: Ciprofloxacin, Metronidazole, & Minocycline




Primary Outcome Measures :
  1. Tooth Survival [ Time Frame: 2 years ]
    1) the growth in hard tissue deposition in the radiographic root area is increased by at least 20%, and 2) the tooth survives to this time point and 3) there is no pain.


Secondary Outcome Measures :
  1. Positive pulpal response [ Time Frame: 2 years ]
    Comparison of treatment effects on positive pulpal responses, crown staining, preoperative factors (age, sex, history of trauma), or antimicrobial efficacy and residual intracanal microbial load would influence the primary outcome measure of tooth survival.



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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976065


Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92350
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Kenneth Hargreaves
University of Maryland
Loma Linda University
University of North Carolina
American Association of Endodontists
Investigators
Study Chair: Kenneth Hargreaves, DDS, PhD University of Texas

Responsible Party: Kenneth Hargreaves, Chair, Dept. of Endodontics, UTHSCSA, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01976065     History of Changes
Other Study ID Numbers: HSC20130467H
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data at this time.

Keywords provided by Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio:
Necrotic tooth pulp
Immature permanent teeth
Regeneration

Additional relevant MeSH terms:
Necrosis
Dental Pulp Necrosis
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Ciprofloxacin
Bacitracin
Neomycin
Polymyxin B
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Local
Protein Synthesis Inhibitors