Tooth Extraction Status NosPhase 1NCT02579187
MicroRNA and MicroRNA Inhibitors Socket Study, Pilot Clinical Trial
A Phase 1 study testing tooth extraction, CBCT scan and Anesthesia in people with Tooth Extraction Status Nos, run by Gustavo Avila-Ortiz DDS, MS, PhD at 1 site in United States.
Trial summary
To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory response on the basis of different clinical, radiographic, histologic and biomolecular outcomes in post-extraction socket defects in humans. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Status Nos
- What is being tested?
- tooth extraction, CBCT scan and Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2025to Sep 2030
- Phase
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 25 to 65 years.
- Gender: No restriction.
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally, endodontically and/or restoratively hopeless).
- Subjects must be able and willing to follow instructions related to the study procedures.
- Subjects must have read, understood and signed an informed consent form.
Who cannot join
- Reported allergy or hypersensitivity to any of the products to be used in the study.
- Severe hematologic disorders, such as leukemia.
- Active severe infectious diseases that may compromise normal healing.
- Liver or kidney dysfunction/failure.
- Currently under cancer treatment or history of cancer of any kind.
- Subjects who have a long-term history of oral bisphosphonate use (i.e. 4 years or more).
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- Subjects with a history of IV bisphosphonates.
- Subjects with uncontrolled diabetes.
- Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded.
- Pregnant women or nursing mothers.
- Smokers: Within 6 months of study onset.
- Concomitant medications: Subjects on concomitant drug therapy for systemic conditions, such as antibiotics or patient taking non-steroidal anti-inflammatory (NSAID) agents that may affect the outcomes of the study will not be included in the study. Subjects taking biologics or disease modifying agents will also be excluded. Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted.
- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Local Delivery of MicroRNAs and MicroRNA Inhibitors in Promoting Osteogenesis and Modulating Local Inflammation: A Pilot Clinical Trial Using the Tooth Socket Model
To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory response on the basis of different clinical, radiographic, histologic and biomolecular outcomes in post-extraction socket defects in humans.
Read the detailed description
The purpose of this study is to evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAS and/or microRNA inhibitors, a naturally occurring microRNA molecule, in the promotion of bone formation and attenuation of local inflammation in a tooth socket model in humans.
Patients requiring tooth extractions and future tooth replacement therapy with a dental implant will be eligible for the study. Recruited subjects will be randomly assigned to either a control (tooth extraction and 10µg empty vector in bovine collagen sponge) or one of 3 experimental groups:
- Experimental group 1: Tooth extraction and bovine collagen sponge containing 10µg of pSil-miR200c
- Experimental Group 2: Tooth extraction and bovine Collagen sponge containing 10µg of PMIS miR200a
- Experimental Group 3: Tooth extraction and bovine Collagen sponge containing 5µg of pSil-miR200c and 5µg of PMIS miR200a
Subjects will be clinically re-evaluated at 1, 2, 3 and 4 weeks. In each one of these visits, a fluid sample will be obtained from the healing site in a minimally invasive manner to assess local biomolecular profiles. Blood samples will be drawn at 1, 2, 3, 4 and 14 week visits to assess for miR-200c and PMIS-miR 200a expression and liver function. Photos and/or videos will also be obtained. A CBCT scan and a saliva sample (approx. 2 ml) will also be obtained at baseline and at 14 weeks to assess bone volume and intraoral biomolecular profiles, respectively.
Implant placement surgery will be performed at 16 weeks from the time of tooth extraction. A bone core biopsy will be harvested at this time for histologic analysis. A periapical radiograph (small dental x-ray image) will be obtained at baseline (before tooth extraction) and at 14 weeks (prior to implant placement) to assess bone height changes.
Follow-up visits will occur at 6 months and 12 months post implant at which time measurements and photos will be taken.
- Conditions
- Tooth Extraction Status Nos
- Being tested
- tooth extraction, CBCT scan, Anesthesia, clinical measurements, Biodegradable sponge (type I bovine collagen)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth extractionProcedure or surgery
The study tooth will be removed
CBCT scanRadiation
a CBCT scan limited to the dental arch that includes the study side will be obtained
AnesthesiaDrug
Also called local infiltrative anesthesia
all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth
clinical measurementsOther
After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
Biodegradable sponge (type I bovine collagen)Drug
Also called Bovine collagen
control group subjects will receive a biodegradable sponge (type I bovine collagen) to stabilize the clot
10µg of pSil-miR200cDrug
Also called pSil-miR-200C plasmids
subjects in the experimental group will receive a 10µg of pSil-miR200c plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot
cross mattress sutureProcedure or surgery
The site will be stabilized with a simplet external, cross mattress suture
10µg of PMIS miR200a plasmidsDrug
Also called PMIS miR200a plasmids
subjects in the experimental group will receive a 10µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot
5µg of pSil-miR200c and 5µg of PMIS miR200aDrug
Also called 5µg of pSil-miR200c and 5µg of PMIS miR200a plasmids
subjects in the experimental group will receive a 5µg of pSil-miR200c and 5µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot
BloodProcedure or surgery
Also called venipuncture
Subjects will have venipuncture performed to obtain a small blood sample (approx. 2 ml) to assess for miR-200c and PMIS-miR-200a expression and liver function (AST, ALT, bilirubin levels)
Photos/videosOther
subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.
Wound fluidProcedure or surgery
a small sample of wound fluid will be obtained from the extraction site in a minimally invasive manner using a paper point at 1, 2, 3 \& 4 weeks post extraction
salivaProcedure or surgery
approximately 2 mls of saliva will be obtained in a minimally invasive manner at the time of extraction and at 14 weeks post extraction.
periapical xrayRadiation
periapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point
PVS impressionOther
PVS impressions will be taken to plan the implant placement surgery. This will be done at the screening visit and also at 14 weeks post extraction.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | CBCT scan limited to the dental arch that includes the study site will be obtained. All subjects will receive local infiltrative anesthesia, following which minimally invasive tooth extraction will be performed. After tooth extraction clinical measurements of the site will also be obtained and recorded for both groups (i.e. keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness). A biodegradable sponge (type I bovine collagen) to stabilize the blood clot will be placed.The site will be stabilized with a simple external, cross mattress suture. Blood , wound fluid, and saliva samples will be taken periodicallly. In addition, photos/videos, periapical xrays and PVS impressions will be obtained. Receives: Procedure: tooth extraction; Radiation: CBCT scan; Drug: Anesthesia; Other: clinical measurements; Drug: Biodegradable sponge (type I bovine collagen); Procedure: cross mattress suture; Procedure: Blood; Other: Photos/videos; Procedure: Wound fluid; Procedure: saliva; Radiation: periapical xray; Other: PVS impression |
| Experimental group 1 | Active comparator | CBCT scan limited to the dental arch that includes the study site will be obtained. All subjects will receive local infiltrative anesthesia, following which minimally invasive tooth extraction will be performed. After tooth extraction clinical measurements of the site will also be obtained and recorded for both groups (i.e. keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness). 10µg of pSil-miR200c plasmids in a biodegradable sponge (type I bovine collagen) will be locally delivered. The site will be stabilized with a simple external, cross mattress suture. Blood, wound fluid, and saliva samples will be taken periodicallly. In addition, photos/videos, periapical xrays and PVS impressions will be obtained. Receives: Procedure: tooth extraction; Radiation: CBCT scan; Drug: Anesthesia; Other: clinical measurements; Drug: 10µg of pSil-miR200c; Procedure: cross mattress suture; Procedure: Blood; Other: Photos/videos; Procedure: Wound fluid; Procedure: saliva; Radiation: periapical xray; Other: PVS impression |
| Experimental group 2 | Active comparator | CBCT scan limited to the dental arch that includes the study site will be obtained. All subjects will receive local infiltrative anesthesia, following which minimally invasive tooth extraction will be performed. After tooth extraction clinical measurements of the site will also be obtained and recorded for both groups (i.e. keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness). 10µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) will be locally delivered. The site will be stabilized with a simple external, cross mattress suture. Blood, wound fluid, and saliva samples will be taken periodicallly. In addition, photos/videos, periapical xrays and PVS impressions will be obtained. Receives: Procedure: tooth extraction; Radiation: CBCT scan; Drug: Anesthesia; Other: clinical measurements; Procedure: cross mattress suture; Drug: 10µg of PMIS miR200a plasmids; Procedure: Blood; Other: Photos/videos; Procedure: Wound fluid; Procedure: saliva; Radiation: periapical xray; Other: PVS impression |
| Experimental group 3 | Active comparator | CBCT scan limited to the dental arch that includes the study site will be obtained. All subjects will receive local infiltrative anesthesia, following which minimally invasive tooth extraction will be performed. After tooth extraction clinical measurements of the site will also be obtained and recorded for both groups (i.e. keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness). 5µg of pSil-miR200c and 5µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) will be locally delivered. The site will be stabilized with a simple external, cross mattress suture. Blood, wound fluid, and saliva samples will be taken periodicallly. In addition, photos/videos, periapical xrays and PVS impressions will be obtained. Receives: Procedure: tooth extraction; Radiation: CBCT scan; Drug: Anesthesia; Other: clinical measurements; Procedure: cross mattress suture; Drug: 5µg of pSil-miR200c and 5µg of PMIS miR200a; Procedure: Blood; Other: Photos/videos; Procedure: Wound fluid; Procedure: saliva; Radiation: periapical xray; Other: PVS impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of mineralized tissue upon histomorphometric analysis of bone core biopsies
compared using exact Wilcoxon rank sum tests
Measured: at 16 weeks postoperatively
Secondary outcomes (5)
Bucco-lingual width changes of the alveolar ridge (in mm)
Fisher's exact tests will be used to compare the treatment groups
Measured: up to 16 weeks postoperatively
Mid-buccal height changes of the alveolar ridge (in mm)
compared using exact Wilcoxon rank sum tests
Measured: up to 16 weeks postoperatively
Mid-lingual height changes of the alveolar ridge (in mm)
compared using exact Wilcoxon rank sum tests
Measured: up to 16 weeks postoperatively
Volumetric reduction of the alveolar ridge (in cc) via CBCT scan analyses
compared using exact Wilcoxon rank sum tests
Measured: at 16 weeks postoperatively
Expression of different biomarkers (VEGF, PDGF, TGF-b, IL-1b, TNF-a) in wound fluid expressed in pg/ml
compared using exact Wilcoxon rank sum tests
Measured: up to 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start31 Dec 2025 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Why it stopped: withdrawn study from IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies 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
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustavo Avila-Ortiz DDS, MS, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gustavo Avila-Ortiz DDS, MS, PhD, University of Iowa
- Investigators
- Brad Amendt, MS, Study director, UIowa College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579187
- Sponsor's protocol ID
- 201607780
- Status last verified
- Jul 2019
- First submitted
- 12 Oct 2015
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Local Delivery of MicroRNAs and MicroRNA Inhibitors in Promoting Osteogenesis and Modulating Local Inflammation: A Pilot Clinical Trial Using the Tooth Socket Model
- ClinicalTrials.gov ID
- NCT02579187
- Acronym / sponsor ID
- 201607780
- Conditions
- Tooth Extraction Status Nos
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn study from IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gustavo Avila-Ortiz DDS, MS, PhDUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 19 Oct 2015 (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.
To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory response on the basis of different clinical, radiographic, histologic and biomolecular outcomes in post-extraction socket defects in humans.
Detailed description
The purpose of this study is to evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAS and/or microRNA inhibitors, a naturally occurring microRNA molecule, in the promotion of bone formation and attenuation of local inflammation in a tooth socket model in humans.
Patients requiring tooth extractions and future tooth replacement therapy with a dental implant will be eligible for the study. Recruited subjects will be randomly assigned to either a control (tooth extraction and 10µg empty vector in bovine collagen sponge) or one of 3 experimental groups:
- Experimental group 1: Tooth extraction and bovine collagen sponge containing 10µg of pSil-miR200c
- Experimental Group 2: Tooth extraction and bovine Collagen sponge containing 10µg of PMIS miR200a
- Experimental Group 3: Tooth extraction and bovine Collagen sponge containing 5µg of pSil-miR200c and 5µg of PMIS miR200a
Subjects will be clinically re-evaluated at 1, 2, 3 and 4 weeks. In each one of these visits, a fluid sample will be obtained from the healing site in a minimally invasive manner to assess local biomolecular profiles. Blood samples will be drawn at 1, 2, 3, 4 and 14 week visits to assess for miR-200c and PMIS-miR 200a expression and liver function. Photos and/or videos will also be obtained. A CBCT scan and a saliva sample (approx. 2 ml) will also be obtained at baseline and at 14 weeks to assess bone volume and intraoral biomolecular profiles, respectively.
Implant placement surgery will be performed at 16 weeks from the time of tooth extraction. A bone core biopsy will be harvested at this time for histologic analysis. A periapical radiograph (small dental x-ray image) will be obtained at baseline (before tooth extraction) and at 14 weeks (prior to implant placement) to assess bone height changes.
Follow-up visits will occur at 6 months and 12 months post implant at which time measurements and photos will be taken.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Procedure: tooth extraction, Radiation: CBCT scan, Drug: Anesthesia, Other: clinical measurements, Drug: Biodegradable sponge (type I bovine collagen), Procedure: cross mattress suture, Procedure: Blood, Other: Photos/videos, Procedure: Wound fluid, Procedure: saliva, Radiation: periapical xray, Other: PVS impressionCBCT scan limited to the dental arch that includes the study site will be obtained. All subjects will receive local infiltrative anesthesia, following which minimally invasive tooth extraction will be performed. After tooth extraction clinical measurements of the site will also be obtained and recorded for both groups (i.e. keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness). A biodegradable sponge (type I bovine collagen) to stabilize the blood clot will be placed.The site will be stabilized with a simple external, cross mattress suture. Blood , wound fluid, and saliva samples will be taken periodicallly. In addition, photos/videos, periapical xrays and PVS impressions will be obtained. |
| Experimental group 1 | Active comparator | Procedure: tooth extraction, Radiation: CBCT scan, Drug: Anesthesia, Other: clinical measurements, Drug: 10µg of pSil-miR200c, Procedure: cross mattress suture, Procedure: Blood, Other: Photos/videos, Procedure: Wound fluid, Procedure: saliva, Radiation: periapical xray, Other: PVS impressionCBCT scan limited to the dental arch that includes the study site will be obtained. All subjects will receive local infiltrative anesthesia, following which minimally invasive tooth extraction will be performed. After tooth extraction clinical measurements of the site will also be obtained and recorded for both groups (i.e. keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness). 10µg of pSil-miR200c plasmids in a biodegradable sponge (type I bovine collagen) will be locally delivered. The site will be stabilized with a simple external, cross mattress suture. Blood, wound fluid, and saliva samples will be taken periodicallly. In addition, photos/videos, periapical xrays and PVS impressions will be obtained. |
| Experimental group 2 | Active comparator | Procedure: tooth extraction, Radiation: CBCT scan, Drug: Anesthesia, Other: clinical measurements, Procedure: cross mattress suture, Drug: 10µg of PMIS miR200a plasmids, Procedure: Blood, Other: Photos/videos, Procedure: Wound fluid, Procedure: saliva, Radiation: periapical xray, Other: PVS impressionCBCT scan limited to the dental arch that includes the study site will be obtained. All subjects will receive local infiltrative anesthesia, following which minimally invasive tooth extraction will be performed. After tooth extraction clinical measurements of the site will also be obtained and recorded for both groups (i.e. keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness). 10µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) will be locally delivered. The site will be stabilized with a simple external, cross mattress suture. Blood, wound fluid, and saliva samples will be taken periodicallly. In addition, photos/videos, periapical xrays and PVS impressions will be obtained. |
| Experimental group 3 | Active comparator | Procedure: tooth extraction, Radiation: CBCT scan, Drug: Anesthesia, Other: clinical measurements, Procedure: cross mattress suture, Drug: 5µg of pSil-miR200c and 5µg of PMIS miR200a, Procedure: Blood, Other: Photos/videos, Procedure: Wound fluid, Procedure: saliva, Radiation: periapical xray, Other: PVS impressionCBCT scan limited to the dental arch that includes the study site will be obtained. All subjects will receive local infiltrative anesthesia, following which minimally invasive tooth extraction will be performed. After tooth extraction clinical measurements of the site will also be obtained and recorded for both groups (i.e. keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness). 5µg of pSil-miR200c and 5µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) will be locally delivered. The site will be stabilized with a simple external, cross mattress suture. Blood, wound fluid, and saliva samples will be taken periodicallly. In addition, photos/videos, periapical xrays and PVS impressions will be obtained. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 25 to 65 years.
- Gender: No restriction.
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally, endodontically and/or restoratively hopeless).
- Subjects must be able and willing to follow instructions related to the study procedures.
- Subjects must have read, understood and signed an informed consent form.
Key exclusion criteria (13 listed)
- Reported allergy or hypersensitivity to any of the products to be used in the study.
- Severe hematologic disorders, such as leukemia.
- Active severe infectious diseases that may compromise normal healing.
- Liver or kidney dysfunction/failure.
- Currently under cancer treatment or history of cancer of any kind.
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 |
|---|---|---|
| tooth extractionThe study tooth will be removed | Procedure or surgery | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| CBCT scana CBCT scan limited to the dental arch that includes the study side will be obtained | Radiation | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| AnesthesiaAlso: local infiltrative anesthesiaall subjects will receive local infiltrative anesthesia, prior to extraction of the tooth | Drug | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| clinical measurementsAfter tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness | Other | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| Biodegradable sponge (type I bovine collagen)Also: Bovine collagencontrol group subjects will receive a biodegradable sponge (type I bovine collagen) to stabilize the clot | Drug | control group |
| 10µg of pSil-miR200cAlso: pSil-miR-200C plasmidssubjects in the experimental group will receive a 10µg of pSil-miR200c plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot | Drug | Experimental group 1 |
| cross mattress sutureThe site will be stabilized with a simplet external, cross mattress suture | Procedure or surgery | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| 10µg of PMIS miR200a plasmidsAlso: PMIS miR200a plasmidssubjects in the experimental group will receive a 10µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot | Drug | Experimental group 2 |
| 5µg of pSil-miR200c and 5µg of PMIS miR200aAlso: 5µg of pSil-miR200c and 5µg of PMIS miR200a plasmidssubjects in the experimental group will receive a 5µg of pSil-miR200c and 5µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot | Drug | Experimental group 3 |
| BloodAlso: venipunctureSubjects will have venipuncture performed to obtain a small blood sample (approx. 2 ml) to assess for miR-200c and PMIS-miR-200a expression and liver function (AST, ALT, bilirubin levels) | Procedure or surgery | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| Photos/videossubjects will have photos and/or videos of the extraction site and/or implant taken at each visit. | Other | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| Wound fluida small sample of wound fluid will be obtained from the extraction site in a minimally invasive manner using a paper point at 1, 2, 3 \& 4 weeks post extraction | Procedure or surgery | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| salivaapproximately 2 mls of saliva will be obtained in a minimally invasive manner at the time of extraction and at 14 weeks post extraction. | Procedure or surgery | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| periapical xrayperiapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point | Radiation | Experimental group 1, Experimental group 2, Experimental group 3, control group |
| PVS impressionPVS impressions will be taken to plan the implant placement surgery. This will be done at the screening visit and also at 14 weeks post extraction. | Other | Experimental group 1, Experimental group 2, Experimental group 3, control group |
Primary outcome
Percent of mineralized tissue upon histomorphometric analysis of bone core biopsies
Time frame: at 16 weeks postoperatively
compared using exact Wilcoxon rank sum tests
5 secondary outcomes
Bucco-lingual width changes of the alveolar ridge (in mm)
Time frame: up to 16 weeks postoperatively
Mid-buccal height changes of the alveolar ridge (in mm)
Time frame: up to 16 weeks postoperatively
Mid-lingual height changes of the alveolar ridge (in mm)
Time frame: up to 16 weeks postoperatively
Volumetric reduction of the alveolar ridge (in cc) via CBCT scan analyses
Time frame: at 16 weeks postoperatively
Expression of different biomarkers (VEGF, PDGF, TGF-b, IL-1b, TNF-a) in wound fluid expressed in pg/ml
Time frame: up to 4 weeks postoperatively
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 17 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Brad Amendt, MS study director
UIowa College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tooth extraction, CBCT scan and Anesthesia in people with Tooth Extraction Status Nos, run by Gustavo Avila-Ortiz DDS, MS, PhD 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 5 inclusion and 13 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 17 Jul 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percent of mineralized tissue upon histomorphometric analysis of bone core biopsies (time frame: at 16 weeks postoperatively). 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 17 Jul 2019.