Tissue Characterization in Teeth Treated With a Regeneration Protocol

NCT00881907 | Completed Early Phase 1 DMC

• 1 other identifier: HSC20090152H
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulp Necrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth.

  three year

Secondary Outcomes (1)

• The secondary outcome measure will be conducted by measuring markers of stem cells prior to and after the formation of the blood clot.

  three year

Study Arms (3)

Group A

EXPERIMENTAL

Group A subjects will be asked to attend a recall visit 2 months following completion of the treatment visits.

Drug: Triple Antibiotic Paste

Group B

EXPERIMENTAL

Group B subjects will be asked to attend a recall visit at 4 months following completion of the treatment visits.

Drug: Triple Antibiotic Paste

Group C

EXPERIMENTAL

Group C subjects will be asked to attend a recall visit at 6 months following completion of the treatment visits.

Drug: Triple Antibiotic Paste

Interventions

Triple Antibiotic Paste DRUG

ciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.

Group A

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenneth M Hargreaves, DDS,PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Endodontics

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: March 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

US (1)