Tissue Characterization in Teeth Treated With a Regeneration Protocol

Completed · Early Phase 1

Conditions studied: Pulp Necrosis

In brief

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.

Key facts

Study ID

NCT00881907

Run by

The University of Texas Health Science Center at San Antonio

People needed

1

Starts

2010-03-01

Expected to finish

2014-03-01

Last updated by the study team

2016-02-05

Who can join

Age: 10 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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