Tooth LossNCT03943849
The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation
A study testing Particulate bone graft, Autogenous dental pulp tissue and Resorbable collagen membrane in people with Tooth Loss, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to examine and compare the effects of autogenous dental pulp tissue on bone formation in the extraction sockets as compared to commonly used particulate bone graft. The effects on bone formation will be examined using a wide variety of assays. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Particulate bone graft, Autogenous dental pulp tissue and Resorbable collagen membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 Sep 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status Classification System ASA 1 (A normal healthy patient) or ASA 2 (A patient with mild systemic disease)
- never smoker
- patients with planned tooth extraction
- intact extraction sockets
- no medication or antibiotics intake for at least 6 months prior to the procedure
- patients who gave their consent to participate in the study.
Who cannot join
- vulnerable subjects (children, pregnant and lactating women, patients with learning disabilities, and prisoners)
- inability to obtain pulp tissue (for example, due to previous endodontic therapy, obliterated pulp canals)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to examine and compare the effects of autogenous dental pulp tissue on bone formation in the extraction sockets as compared to commonly used particulate bone graft. The effects on bone formation will be examined using a wide variety of assays.
- Conditions
- Tooth Loss
- Being tested
- Particulate bone graft, Autogenous dental pulp tissue, Resorbable collagen membrane, Suture
- Keywords
- Bone graft, Tooth extraction, Dental pulp
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Particulate bone graftOther
Also called creos allo.gain, allogenic bone particulates
Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
Autogenous dental pulp tissueOther
Dental pulp will be isolated from teeth extracted for non-periodontal reasons chairside, mixed with hydrated particulate bone graft, and then placed in the extraction socket.
Resorbable collagen membraneOther
After placement of particulate bone graft or particulate bone graft plus autogenous dental pulp tissue, socket will be covered by a resorbable collagen membrane and sutured.
SutureOther
Resorbable or non-resorbable suture material
| Study group | Role | What they receive |
|---|---|---|
| Particulate bone graft plus autogenous dental pulp tissue | Experimental | Dental pulp will be isolated from teeth extracted for non-periodontal reasons chairside. The isolated dental pulp will be mixed with hydrated particulate bone graft, and the mixture will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured. Receives: Other: Particulate bone graft; Other: Autogenous dental pulp tissue; Other: Resorbable collagen membrane; Other: Suture |
| Particulate bone graft | Active comparator | Hydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured. Receives: Other: Particulate bone graft; Other: Resorbable collagen membrane; Other: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fill as assessed by radiograph
Measured: immediately after placement of bone graft
Bone fill as assessed by radiograph
Measured: 2 months after placement of bone graft
Bone fill as assessed by radiograph
Measured: 4 months after placement of bone graft
Secondary outcomes (10)
Extent of mineralization as assessed by von Kossa staining
Measured: 4 months after placement of bone graft
Extent of mineralization as assessed by Xylenol Orange staining
Measured: 4 months after placement of bone graft
Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR)
Measured: 4 months after placement of bone graft
Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody
Measured: 4 months after placement of bone graft
Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR)
Measured: 4 months after placement of bone graft
Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody
Measured: 4 months after placement of bone graft
Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR)
Measured: 4 months after placement of bone graft
Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody
Measured: 4 months after placement of bone graft
Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)
Measured: 4 months after placement of bone graft
Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)
Measured: 4 months after placement of bone graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 May 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karo Parsegian, The University of Texas Health Science Center, Houston
- Investigators
- Karo Parsegian, DMD, MDSc, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943849
- Sponsor's protocol ID
- HSC-DB-18-0873
- Status last verified
- Jan 2022
- First submitted
- 7 May 2019
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation
- ClinicalTrials.gov ID
- NCT03943849
- Acronym / sponsor ID
- HSC-DB-18-0873
- Conditions
- Tooth Loss
- Keywords
- Bone graft, Tooth extraction, Dental pulp
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 May 2019 (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 study is to examine and compare the effects of autogenous dental pulp tissue on bone formation in the extraction sockets as compared to commonly used particulate bone graft. The effects on bone formation will be examined using a wide variety of assays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Particulate bone graft plus autogenous dental pulp tissue | Experimental | Other: Particulate bone graft, Other: Autogenous dental pulp tissue, Other: Resorbable collagen membrane, Other: SutureDental pulp will be isolated from teeth extracted for non-periodontal reasons chairside. The isolated dental pulp will be mixed with hydrated particulate bone graft, and the mixture will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured. |
| Particulate bone graft | Active comparator | Other: Particulate bone graft, Other: Resorbable collagen membrane, Other: SutureHydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- American Society of Anesthesiologists (ASA) Physical Status Classification System ASA 1 (A normal healthy patient) or ASA 2 (A patient with mild systemic disease)
- never smoker
- patients with planned tooth extraction
- intact extraction sockets
- no medication or antibiotics intake for at least 6 months prior to the procedure
Key exclusion criteria (2 listed)
- vulnerable subjects (children, pregnant and lactating women, patients with learning disabilities, and prisoners)
- inability to obtain pulp tissue (for example, due to previous endodontic therapy, obliterated pulp canals)
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 |
|---|---|---|
| Particulate bone graftAlso: creos allo.gain, allogenic bone particulatesCreos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket. | Other | Particulate bone graft, Particulate bone graft plus autogenous dental pulp tissue |
| Autogenous dental pulp tissueDental pulp will be isolated from teeth extracted for non-periodontal reasons chairside, mixed with hydrated particulate bone graft, and then placed in the extraction socket. | Other | Particulate bone graft plus autogenous dental pulp tissue |
| Resorbable collagen membraneAfter placement of particulate bone graft or particulate bone graft plus autogenous dental pulp tissue, socket will be covered by a resorbable collagen membrane and sutured. | Other | Particulate bone graft, Particulate bone graft plus autogenous dental pulp tissue |
| SutureResorbable or non-resorbable suture material | Other | Particulate bone graft, Particulate bone graft plus autogenous dental pulp tissue |
Primary outcome
Bone fill as assessed by radiograph
Time frame: immediately after placement of bone graft
Bone fill as assessed by radiograph
Time frame: 2 months after placement of bone graft
Bone fill as assessed by radiograph
Time frame: 4 months after placement of bone graft
10 secondary outcomes
Extent of mineralization as assessed by von Kossa staining
Time frame: 4 months after placement of bone graft
Extent of mineralization as assessed by Xylenol Orange staining
Time frame: 4 months after placement of bone graft
Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR)
Time frame: 4 months after placement of bone graft
Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody
Time frame: 4 months after placement of bone graft
Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR)
Time frame: 4 months after placement of bone graft
Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody
Time frame: 4 months after placement of bone graft
Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR)
Time frame: 4 months after placement of bone graft
Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody
Time frame: 4 months after placement of bone graft
Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)
Time frame: 4 months after placement of bone graft
Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)
Time frame: 4 months after placement of bone graft
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 3 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Tooth Loss
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
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.
Karo Parsegian, DMD, MDSc, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Particulate bone graft, Autogenous dental pulp tissue and Resorbable collagen membrane in people with Tooth Loss, run by The University of Texas Health Science Center, Houston 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 6 inclusion and 2 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 3 Feb 2022. 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.
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?
Bone fill as assessed by radiograph (time frame: immediately after placement of bone graft). The study lists 3 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 3 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.