MicroRNA and MicroRNA Inhibitors Socket Study, Pilot Clinical Trial
NCT ID: NCT02579187
Last Updated: 2019-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2025-12-31
2030-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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control group
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.
tooth extraction
The study tooth will be removed
CBCT scan
a CBCT scan limited to the dental arch that includes the study side will be obtained
Anesthesia
all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth
clinical measurements
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)
control group subjects will receive a biodegradable sponge (type I bovine collagen) to stabilize the clot
cross mattress suture
The site will be stabilized with a simplet external, cross mattress suture
Blood
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/videos
subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.
Wound fluid
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
saliva
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 xray
periapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point
PVS impression
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.
Experimental group 1
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.
tooth extraction
The study tooth will be removed
CBCT scan
a CBCT scan limited to the dental arch that includes the study side will be obtained
Anesthesia
all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth
clinical measurements
After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
10µg of pSil-miR200c
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 suture
The site will be stabilized with a simplet external, cross mattress suture
Blood
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/videos
subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.
Wound fluid
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
saliva
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 xray
periapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point
PVS impression
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.
Experimental group 2
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.
tooth extraction
The study tooth will be removed
CBCT scan
a CBCT scan limited to the dental arch that includes the study side will be obtained
Anesthesia
all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth
clinical measurements
After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
cross mattress suture
The site will be stabilized with a simplet external, cross mattress suture
10µg of 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
Blood
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/videos
subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.
Wound fluid
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
saliva
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 xray
periapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point
PVS impression
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.
Experimental group 3
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.
tooth extraction
The study tooth will be removed
CBCT scan
a CBCT scan limited to the dental arch that includes the study side will be obtained
Anesthesia
all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth
clinical measurements
After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
cross mattress suture
The site will be stabilized with a simplet external, cross mattress suture
5µg of pSil-miR200c and 5µg of PMIS miR200a
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
Blood
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/videos
subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.
Wound fluid
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
saliva
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 xray
periapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point
PVS impression
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.
Interventions
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tooth extraction
The study tooth will be removed
CBCT scan
a CBCT scan limited to the dental arch that includes the study side will be obtained
Anesthesia
all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth
clinical measurements
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)
control group subjects will receive a biodegradable sponge (type I bovine collagen) to stabilize the clot
10µg of pSil-miR200c
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 suture
The site will be stabilized with a simplet external, cross mattress suture
10µg of 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 miR200a
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
Blood
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/videos
subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.
Wound fluid
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
saliva
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 xray
periapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point
PVS impression
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
25 Years
65 Years
ALL
Yes
Sponsors
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Gustavo Avila-Ortiz DDS, MS, PhD
OTHER
Responsible Party
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Gustavo Avila-Ortiz DDS, MS, PhD
DDS
Principal Investigators
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Brad Amendt, MS
Role: STUDY_DIRECTOR
UIowa College of Dentistry
Locations
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UIowa
Iowa City, Iowa, United States
Countries
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Other Identifiers
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201607780
Identifier Type: -
Identifier Source: org_study_id
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