Tooth Extraction Status Nos Clinical Trial
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.
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.
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