- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02579187
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
Study Overview
Status
Conditions
Intervention / Treatment
- 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
- Drug: 10µg of pSil-miR200c
- Drug: 10µg of PMIS miR200a plasmids
- Drug: 5µg of pSil-miR200c and 5µg of PMIS miR200a
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 Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- UIowa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
- 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.
EXCLUSION CRITERIA
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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.
|
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
Other Names:
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
Other Names:
The site will be stabilized with a simplet external, cross mattress suture
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)
Other Names:
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.
|
Active Comparator: 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.
|
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
Other Names:
After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
The site will be stabilized with a simplet external, cross mattress suture
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)
Other Names:
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.
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
Other Names:
|
Active Comparator: 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.
|
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
Other Names:
After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
The site will be stabilized with a simplet external, cross mattress suture
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)
Other Names:
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.
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
Other Names:
|
Active Comparator: 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.
|
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
Other Names:
After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
The site will be stabilized with a simplet external, cross mattress suture
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)
Other Names:
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.
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of mineralized tissue upon histomorphometric analysis of bone core biopsies
Time Frame: at 16 weeks postoperatively
|
compared using exact Wilcoxon rank sum tests
|
at 16 weeks postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bucco-lingual width changes of the alveolar ridge (in mm)
Time Frame: up to 16 weeks postoperatively
|
Fisher's exact tests will be used to compare the treatment groups
|
up to 16 weeks postoperatively
|
Mid-buccal height changes of the alveolar ridge (in mm)
Time Frame: up to 16 weeks postoperatively
|
compared using exact Wilcoxon rank sum tests
|
up to 16 weeks postoperatively
|
Mid-lingual height changes of the alveolar ridge (in mm)
Time Frame: up to 16 weeks postoperatively
|
compared using exact Wilcoxon rank sum tests
|
up to 16 weeks postoperatively
|
Volumetric reduction of the alveolar ridge (in cc) via CBCT scan analyses
Time Frame: at 16 weeks postoperatively
|
compared using exact Wilcoxon rank sum tests
|
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
|
compared using exact Wilcoxon rank sum tests
|
up to 4 weeks postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Brad Amendt, MS, UIowa College of Dentistry
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201607780
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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