Pulp Necrosis
Conditions
Keywords
Regeneration (revascularization) of dental pulp, Immature Permanent Tooth With a Diagnosis of Pulpal Necrosis
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.
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.
Interventions
ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth. | three year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed