Root Canal TherapyPhase 2NCT03613090
Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue
A Phase 2 study testing Collagen-hydroxyapatite scaffold (Syn-Oss) and Collagen Scaffold (Colla-Plug) in people with Root Canal Therapy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this investigation is to assess the use of a novel scaffold (an FDA-approved collagen-hydroxyapatite material called Syn-Oss) for regeneration of pulp tissues versus the use of a traditional scaffold (blood clot). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Canal Therapy
- What is being tested?
- Collagen-hydroxyapatite scaffold (Syn-Oss) and Collagen Scaffold (Colla-Plug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Apr 2019
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Single root canal space apparent on a standard dental periapical radiograph
- Immature tooth apex width at least 1.1mm in diameter as measured from the radiograph
- No history of antibiotic drug allergy
- Necrotic pulp as demonstrated by coronal discoloration.
- Periapical radiolucency
- Negative pulp sensibility tests
- Other standard clinical means of assessing pulp vitality status
Who cannot join
- 1. Any patients having an American Association of Anesthesiologists 4 health classification will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The purpose of this investigation is to assess the use of a novel scaffold (an FDA-approved collagen-hydroxyapatite material called Syn-Oss) for regeneration of pulp tissues versus the use of a traditional scaffold (blood clot).
Read the detailed description
Regeneration of pulp tissues in teeth with immature roots is a new concept based on historical limited success using calcium hydroxide dressings placed into debrided pulp spaces. Obtaining stem cells from the apical papilla (SCAP cells), which are present at the base of all teeth, but are most accessible in teeth with immature apices, greatly enhances clinical success. Current therapies lack ideal messenger chemicals and scaffolds to optimize results.
- Conditions
- Root Canal Therapy
- Being tested
- Collagen-hydroxyapatite scaffold (Syn-Oss), Collagen Scaffold (Colla-Plug)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen-hydroxyapatite scaffold (Syn-Oss)Drug
The aim of this study is to add to the existing body of regenerative endodontics research by providing human radiographic evidence for the healing process which occurs after the placement of a FDA-approved collagen-hydroxyapatite scaffold, in the use of a blood clot
Collagen Scaffold (Colla-Plug)Drug
Traditionally, endodontic therapy consisted of removing the infected dental pulp from the canal spaces and replacing it with an artificial substitute called gutta percha. Regenerative endodontic research efforts were originally concentrated upon treatment of the immature necrotic tooth whereby stem cells from the bone near the root end were stimulated to grow onto a blood clot scaffold created within the debrided and disinfected canal space. The hope is that the stem cells would differentiate into cells which could potentially replace the lost pulpal tissues, restoring what was lost due to infection.
| Study group | Role | What they receive |
|---|---|---|
| Collagen-hydroxyapatite Scaffold (Syn-Oss) | Experimental | Placement of a collagen-hydroxyapatite scaffold (Syn-Oss), placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material). Receives: Drug: Collagen-hydroxyapatite scaffold (Syn-Oss) |
| Collagen Scaffold (Colla-Plug) | Active comparator | Placement of a collagen scaffold (Colla-Plug) over a blood clot, placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material). The Colla-Plug material is placed adjacent to the blood clot that has formed inside the root canal space. It act as a matrix for the subsequent placement of the mineral trioxide aggregate material. It has been used as the standard of care in regenerative endodontics since 2004. Receives: Drug: Collagen Scaffold (Colla-Plug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation 1-Radiodensity at apex @ 1mm from root vertex
Grade 1 = no disruption of apical anatomy Grade 2 = Periodontal ligament (PDL) width double thickness, with intact lamina dura Grade 3 = break in lamina dura
Measured: Month 0-3, Institutional Review Board proposal and approval
Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study.
Grade 1 = dentin wall thickness increased by > 1mm Grade 2 = dentin wall thickness < 1mm
Measured: Months 3-6, patient recruitment and revascularization surgery in Department of Endodontics
Observation 3 - Increase in root length, in mm.
Grade 1 = root length increased > 1 mm Grade 2 = root length increased 0-1 mm Grade 3 = root length shorter than pre-op
Measured: Month 6-12, clinical and radiographic recall and assessment
Observation 4 - Periradicular status
Grade 1 = no periradicular radiolucency Grade 2 = periradicular radiolucency 0-1 mm in diameter Grade 3 = periradicular radiolucency > 1 mm in diameter
Measured: Month 13-15, data analysis and manuscript preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Why it stopped: Withdrawn-was not approved by IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TherapyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will screen routine root canal treatment-seeking patients who present normally to clinic as potential study participants. The patients selected will be those who will require root canal therapy as a part of their routine dental care. Participant will be randomly assigned to one or two groups:
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Collagen Matrix
- Responsible party
- Principal investigator, David Clanton DMD, University of Alabama at Birmingham
- Investigators
- David Clanton, DMD, Principal investigator, Univeristy of Alabama at BirminghamPaul D Eleazer, DDS, Principal investigator, Univeristy of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613090
- Sponsor's protocol ID
- IRB-161031003
- Status last verified
- May 2019
- First submitted
- 19 Jun 2018
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue
- ClinicalTrials.gov ID
- NCT03613090
- Acronym / sponsor ID
- IRB-161031003
- Conditions
- Root Canal Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn-was not approved by IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Collagen Matrix
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 2 Aug 2018 (actual)
- 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 this investigation is to assess the use of a novel scaffold (an FDA-approved collagen-hydroxyapatite material called Syn-Oss) for regeneration of pulp tissues versus the use of a traditional scaffold (blood clot).
Detailed description
Regeneration of pulp tissues in teeth with immature roots is a new concept based on historical limited success using calcium hydroxide dressings placed into debrided pulp spaces. Obtaining stem cells from the apical papilla (SCAP cells), which are present at the base of all teeth, but are most accessible in teeth with immature apices, greatly enhances clinical success. Current therapies lack ideal messenger chemicals and scaffolds to optimize results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigators will screen routine root canal treatment-seeking patients who present normally to clinic as potential study participants. The patients selected will be those who will require root canal therapy as a part of their routine dental care. Participant will be randomly assigned to one or two groups:
| Arm | Type | Receives |
|---|---|---|
| Collagen-hydroxyapatite Scaffold (Syn-Oss) | Experimental | Drug: Collagen-hydroxyapatite scaffold (Syn-Oss)Placement of a collagen-hydroxyapatite scaffold (Syn-Oss), placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material). |
| Collagen Scaffold (Colla-Plug) | Active comparator | Drug: Collagen Scaffold (Colla-Plug)Placement of a collagen scaffold (Colla-Plug) over a blood clot, placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material). The Colla-Plug material is placed adjacent to the blood clot that has formed inside the root canal space. It act as a matrix for the subsequent placement of the mineral trioxide aggregate material. It has been used as the standard of care in regenerative endodontics since 2004. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Single root canal space apparent on a standard dental periapical radiograph
- Immature tooth apex width at least 1.1mm in diameter as measured from the radiograph
- No history of antibiotic drug allergy
- Necrotic pulp as demonstrated by coronal discoloration.
- Periapical radiolucency
Key exclusion criteria (1 listed)
- 1. Any patients having an American Association of Anesthesiologists 4 health classification will be excluded.
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 |
|---|---|---|
| Collagen-hydroxyapatite scaffold (Syn-Oss)The aim of this study is to add to the existing body of regenerative endodontics research by providing human radiographic evidence for the healing process which occurs after the placement of a FDA-approved collagen-hydroxyapatite scaffold, in the use of a blood clot | Drug | Collagen-hydroxyapatite Scaffold (Syn-Oss) |
| Collagen Scaffold (Colla-Plug)Traditionally, endodontic therapy consisted of removing the infected dental pulp from the canal spaces and replacing it with an artificial substitute called gutta percha. Regenerative endodontic research efforts were originally concentrated upon treatment of the immature necrotic tooth whereby stem cells from the bone near the root end were stimulated to grow onto a blood clot scaffold created within the debrided and disinfected canal space. The hope is that the stem cells would differentiate into cells which could potentially replace the lost pulpal tissues, restoring what was lost due to infection. | Drug | Collagen Scaffold (Colla-Plug) |
Primary outcome
Observation 1-Radiodensity at apex @ 1mm from root vertex
Time frame: Month 0-3, Institutional Review Board proposal and approval
Grade 1 = no disruption of apical anatomy Grade 2 = Periodontal ligament (PDL) width double thickness, with intact lamina dura Grade 3 = break in lamina dura
Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study.
Time frame: Months 3-6, patient recruitment and revascularization surgery in Department of Endodontics
Grade 1 = dentin wall thickness increased by > 1mm Grade 2 = dentin wall thickness < 1mm
Observation 3 - Increase in root length, in mm.
Time frame: Month 6-12, clinical and radiographic recall and assessment
Grade 1 = root length increased > 1 mm Grade 2 = root length increased 0-1 mm Grade 3 = root length shorter than pre-op
Observation 4 - Periradicular status
Time frame: Month 13-15, data analysis and manuscript preparation
Grade 1 = no periradicular radiolucency Grade 2 = periradicular radiolucency 0-1 mm in diameter Grade 3 = periradicular radiolucency > 1 mm in diameter
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
Related trials for Root Canal Therapy
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
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.
David Clanton, DMD principal investigator
Univeristy of Alabama at Birmingham
Paul D Eleazer, DDS principal investigator
Univeristy of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Collagen-hydroxyapatite scaffold (Syn-Oss) and Collagen Scaffold (Colla-Plug) in people with Root Canal Therapy, run by University of Alabama at Birmingham 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 7 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 May 2019. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Observation 1-Radiodensity at apex @ 1mm from root vertex (time frame: Month 0-3, Institutional Review Board proposal and approval). The study lists 4 primary outcomes in all. 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 23 May 2019.