Tissue Characterization in Teeth Treated With a Regeneration Protocol - Full Text View

Purpose

The purpose of the investigators study is to characterize the composition of the hard and soft tissues present in root canals of teeth previously diagnosed with necrotic pulps and incomplete root formation and treated with a triple antibiotic regeneration protocol. The investigators hypothesis is that treatment of teeth with necrotic pulps and immature apices with triple antibiotic paste will stimulate continued root formation by the deposition of dentin at the root apices. The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth.

Condition	Intervention	Phase
Pulp Necrosis	Drug: Triple Antibiotic Paste	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Tissue Characterization in Teeth Treated With a Regeneration Protocol

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Neocidin Statrol

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth. [ Time Frame: three year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcome measure will be conducted by measuring markers of stem cells prior to and after the formation of the blood clot. [ Time Frame: three year ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	December 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Group A subjects will be asked to attend a recall visit 2 months following completion of the treatment visits.	Drug: Triple Antibiotic Paste ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation. Other Name: Triple Antibiotic Paste
Experimental: Group B Group B subjects will be asked to attend a recall visit at 4 months following completion of the treatment visits.	Drug: Triple Antibiotic Paste ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation. Other Name: Triple Antibiotic Paste
Experimental: Group C Group C subjects will be asked to attend a recall visit at 6 months following completion of the treatment visits.	Drug: Triple Antibiotic Paste ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation. Other Name: Triple Antibiotic Paste

Detailed Description:

'Regeneration' as referred to in this protocol refers to the stimulation of continued root formation by the deposition of apical tissues subsequent to disinfection of a necrotic root canal and its contents and creation of a scaffold upon which cells can proliferate. While the proposed treatment protocol is currently being used in clinical practice and has been shown to be successful in case reports and case series, the nature of the proliferating apical tissues remains unknown. Thus, this study is uniquely positioned to address a critical gap in knowledge in the regeneration of a functional pulp-dentin complex. Moreover, results obtained from pediatric cases may well provide the essential foundation of knowledge for endodontists to apply this knowledge to the more difficult situation of regenerating the pulp-dentin complex of the full mature permanent tooth.

Eligibility

Ages Eligible for Study:	10 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patient Inclusion Criteria:
- Healthy volunteers ages 10-60 with a non-restorable (as determined by referring dentist), permanent tooth with a necrotic pulp and incomplete root development.
- Persons who seem to be cooperative with dental treatment and able to indicate willingness to obtain treatment and participate in the study and who are capable of verbally expressing dissent.
- Parents who express understanding of study treatments and consent to treatment for their child of the regenerative procedure.
- Healthy patients (ASA Class I or II physical status) with no systemic health problems that may interfere with healing and cell growth.
Tooth inclusion criteria:
- Permanent tooth with necrotic pulp and immature root development, scheduled for extraction due to non-restorability.
- Clinically confirmed necrotic pulp that will be confirmed with common endodontic pulp vitality tests (No response to cold or electric pulp test).
- Clinically confirmed immature root development that will be assessed radiographically to confirm the non-restorability as diagnosed by the referring dentist.

Exclusion Criteria:

Patient Exclusion Criteria:
- Parents and patients unable to give consent or express dissent.
- Patients who are unwilling to undergo the dental treatment.
- Patients affected by temporomandibular joint disorders.
- Patients affected by known orofacial pain disorders.
- Patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report that they are an HIV carrier, undergoing steroid therapy or chemotherapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response).
Tooth Exclusion Criteria:
- Teeth with vertical cracks that extend below the cemento-enamel junction.
- Teeth that cannot be isolated using a rubber dam.
- Teeth with non-odontogenic pathology.
- Teeth whose apices are fully developed, as determined radiographically and correlated with dental age of patient.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881907

Contacts

Contact: Kenneth M Hargreaves, DDS,PhD	210-567-3381	hargreaves@uthscsa.edu
Contact: Lola Miranda	210-567-0873	MirandaM4@uthscsa.edu

Locations

United States, Texas
University of Texas Health Science Center	Recruiting
San Antonio, Texas, United States, 78229
Contact: Erin Locke, RN 210-567-0895 locke@uthscsa.edu
Principal Investigator: Kenneth M Hargreavaes, DDS,PhD

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator:

Kenneth M Hargreaves, DDS,PhD

University of Texas

More Information

No publications provided

Responsible Party:	Kenneth Hargreaves, Chair, Department of Endodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00881907 History of Changes
Other Study ID Numbers:	HSC20090152H
Study First Received:	April 14, 2009
Last Updated:	March 19, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:

Regeneration (revascularization) of dental pulp
Immature Permanent Tooth With a Diagnosis of Pulpal Necrosis

Additional relevant MeSH terms:

Anti-Bacterial Agents
Dental Pulp Necrosis
Necrosis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Pathologic Processes
Bacitracin
Neomycin

Polymyxin B
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013