Tissue Characterization in Teeth Treated With a Regeneration Protocol
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ClinicalTrials.gov Identifier: NCT00881907 |
Recruitment Status :
Completed
First Posted : April 15, 2009
Last Update Posted : February 5, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulp Necrosis | Drug: Triple Antibiotic Paste | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Tissue Characterization in Teeth Treated With a Regeneration Protocol |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Group A
Group A subjects will be asked to attend a recall visit 2 months following completion of the treatment visits.
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Drug: Triple Antibiotic Paste
ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation. |
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. |
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. |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 10 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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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.
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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:
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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).
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881907
United States, Texas | |
University of Texas Health Science Center | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Kenneth M Hargreaves, DDS,PhD | University of Texas |
Responsible Party: | Kenneth Hargreaves, Chair, Department of Endodontics, The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT00881907 |
Other Study ID Numbers: |
HSC20090152H |
First Posted: | April 15, 2009 Key Record Dates |
Last Update Posted: | February 5, 2016 |
Last Verified: | February 2016 |
Regeneration (revascularization) of dental pulp Immature Permanent Tooth With a Diagnosis of Pulpal Necrosis |
Dental Pulp Necrosis Necrosis Pathologic Processes Dental Pulp Diseases Tooth Diseases Stomatognathic Diseases Anti-Bacterial Agents Bacitracin Neomycin |
Polymyxin B Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents Anti-Infective Agents, Local Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |