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

Primary Purpose

Pulp Necrosis, Regeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Triple Antibiotic Paste
Standard Treatment
Sponsored by
Kenneth Hargreaves
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necrosis focused on measuring Necrotic tooth pulp, Immature permanent teeth, Regeneration

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Other

Experimental

Experimental

Arm Label

Mineral Trioxide Aggregate (MTA)

Revascularization Treatment (REVASC)

Regeneration Treatment (REGENDO)

Arm Description

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.

Outcomes

Primary Outcome Measures

Tooth Survival
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

Positive pulpal response
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.

Full Information

First Posted
October 29, 2013
Last Updated
September 6, 2023
Sponsor
Kenneth Hargreaves
Collaborators
University of Maryland, Baltimore, Loma Linda University, University of North Carolina, American Association of Endodontists
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1. Study Identification

Unique Protocol Identification Number
NCT01976065
Brief Title
Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
Official Title
Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 24, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Hargreaves
Collaborators
University of Maryland, Baltimore, Loma Linda University, University of North Carolina, American Association of Endodontists

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necrosis, Regeneration
Keywords
Necrotic tooth pulp, Immature permanent teeth, Regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mineral Trioxide Aggregate (MTA)
Arm Type
Other
Arm Description
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).
Arm Title
Revascularization Treatment (REVASC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Regeneration Treatment (REGENDO)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Triple Antibiotic Paste
Other Intervention Name(s)
Ciprofloxacin, Metronidazole, & Minocycline
Intervention Description
USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency
Intervention Type
Other
Intervention Name(s)
Standard Treatment
Other Intervention Name(s)
No use of study drug
Intervention Description
Standard Treatment no use of study drug
Primary Outcome Measure Information:
Title
Tooth Survival
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Positive pulpal response
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Hargreaves, DDS, PhD
Organizational Affiliation
University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data at this time.

Learn more about this trial

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

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