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Tissue Characterization in Teeth Treated With a Regeneration Protocol

Primary Purpose

Pulp Necrosis

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Triple Antibiotic Paste

About this trial

This is an interventional treatment trial for Pulp Necrosis focused on measuring Regeneration (revascularization) of dental pulp, Immature Permanent Tooth With a Diagnosis of Pulpal Necrosis

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

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.

Full Information

NCT ID

NCT00881907

First Posted

April 14, 2009

Last Updated

February 4, 2016

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT00881907

Brief Title

Tissue Characterization in Teeth Treated With a Regeneration Protocol

Official Title

Tissue Characterization in Teeth Treated With a Regeneration Protocol

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulp Necrosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Arm Title

Group C

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Triple Antibiotic Paste

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Triple Antibiotic Paste

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Triple Antibiotic Paste

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth M Hargreaves, DDS,PhD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Science Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

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Tissue Characterization in Teeth Treated With a Regeneration Protocol

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