Pulp NecrosisEarly Phase 1NCT00881907
Tissue Characterization in Teeth Treated With a Regeneration Protocol
A Early Phase 1 study testing Triple Antibiotic Paste in people with Pulp Necrosis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- Triple Antibiotic Paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Pulp Necrosis
- Being tested
- Triple Antibiotic Paste
- Keywords
- Regeneration (revascularization) of dental pulp, Immature Permanent Tooth With a Diagnosis of Pulpal Necrosis
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple Antibiotic PasteDrug
ciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.
Triple Antibiotic PasteDrug
ciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.
Triple Antibiotic PasteDrug
ciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A subjects will be asked to attend a recall visit 2 months following completion of the treatment visits. Receives: 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. Receives: 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. Receives: Drug: Triple Antibiotic Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth.
Measured: 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.
Measured: three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startMar 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
- Investigators
- Kenneth M Hargreaves, DDS,PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881907
- Sponsor's protocol ID
- HSC20090152H
- Status last verified
- Feb 2016
- First submitted
- 14 Apr 2009
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Characterization in Teeth Treated With a Regeneration Protocol
- ClinicalTrials.gov ID
- NCT00881907
- Acronym / sponsor ID
- HSC20090152H
- Conditions
- Pulp Necrosis
- Keywords
- Regeneration (revascularization) of dental pulp, Immature Permanent Tooth With a Diagnosis of Pulpal Necrosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Triple Antibiotic PasteGroup A subjects will be asked to attend a recall visit 2 months following completion of the treatment visits. |
| Group B | Experimental | Drug: Triple Antibiotic PasteGroup B subjects will be asked to attend a recall visit at 4 months following completion of the treatment visits. |
| Group C | Experimental | Drug: Triple Antibiotic PasteGroup C subjects will be asked to attend a recall visit at 6 months following completion of the treatment visits. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patient Inclusion Criteria:
- Tooth inclusion criteria:
Key exclusion criteria (11 listed)
- Patient Exclusion Criteria:
- Tooth Exclusion Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple Antibiotic Pasteciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation. | Drug | Group A |
| Triple Antibiotic Pasteciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation. | Drug | Group B |
| Triple Antibiotic Pasteciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation. | Drug | Group C |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Hargreaves, DDS,PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Triple Antibiotic Paste in people with Pulp Necrosis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.