Study Stopped
withdrawn study from IRB
MicroRNA and MicroRNA Inhibitors Socket Study, Pilot Clinical Trial
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
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2025
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedStudy Start
First participant enrolled
December 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
July 17, 2019
July 1, 2019
4.7 years
October 12, 2015
July 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of mineralized tissue upon histomorphometric analysis of bone core biopsies
compared using exact Wilcoxon rank sum tests
at 16 weeks postoperatively
Secondary Outcomes (5)
Bucco-lingual width changes of the alveolar ridge (in mm)
up to 16 weeks postoperatively
Mid-buccal height changes of the alveolar ridge (in mm)
up to 16 weeks postoperatively
Mid-lingual height changes of the alveolar ridge (in mm)
up to 16 weeks postoperatively
Volumetric reduction of the alveolar ridge (in cc) via CBCT scan analyses
at 16 weeks postoperatively
Expression of different biomarkers (VEGF, PDGF, TGF-b, IL-1b, TNF-a) in wound fluid expressed in pg/ml
up to 4 weeks postoperatively
Study Arms (4)
control group
PLACEBO COMPARATORCBCT 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 COMPARATORCBCT 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 COMPARATORCBCT 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 COMPARATORCBCT 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.
Interventions
The study tooth will be removed
a CBCT scan limited to the dental arch that includes the study side will be obtained
all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth
After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
control group subjects will receive a biodegradable sponge (type I bovine collagen) to stabilize the clot
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
The site will be stabilized with a simplet external, cross mattress suture
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
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
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)
subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.
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
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 xrays will be obtained at screening, 16 weeks and at 12 month followup time point
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UIowa
Iowa City, Iowa, 52242, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brad Amendt, MS
UIowa College of Dentistry
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- DDS
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 19, 2015
Study Start
December 31, 2025
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
September 1, 2030
Last Updated
July 17, 2019
Record last verified: 2019-07