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

NCT01976065 | Completed Phase 1 DMC

• 1 other identifier: HSC20130467H
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 4

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.

Conditions

Pulp Necrosis; Regeneration

Keywords

Necrotic tooth pulp; Immature permanent teeth; Regeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Positive pulpal response

  2 years

Study Arms (3)

Mineral Trioxide Aggregate (MTA)

OTHER

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

Revascularization Treatment (REVASC)

EXPERIMENTAL

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

Regeneration Treatment (REGENDO)

EXPERIMENTAL

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

Interventions

Triple Antibiotic Paste DRUG

USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency

Also known as: Ciprofloxacin, Metronidazole, & Minocycline

Regeneration Treatment (REGENDO); Revascularization Treatment (REVASC)

Standard Treatment OTHER

Standard Treatment no use of study drug

Also known as: No use of study drug

Mineral Trioxide Aggregate (MTA)

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kenneth Hargreaves: lead
• University of Maryland, Baltimore: collaborator
• Loma Linda University: collaborator
• University of North Carolina: collaborator
• American Association of Endodontists: collaborator

Study Sites (4)

Loma Linda University

Loma Linda, California, 92350, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Ciprofloxacin; Metronidazole; Minocycline

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Kenneth Hargreaves, DDS, PhD

  University of Texas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Dept. of Endodontics, UTHSCSA

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 5, 2013
• Study Start: September 1, 2014
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)