MicroRNA and MicroRNA Inhibitors Socket Study, Pilot Clinical 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.

Conditions

• Tooth Extraction Status Nos

Interventions

PROCEDURE

tooth extraction

The study tooth will be removed

RADIATION

CBCT scan

a CBCT scan limited to the dental arch that includes the study side will be obtained

DRUG

Anesthesia

all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth

OTHER

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

DRUG

Biodegradable sponge (type I bovine collagen)

control group subjects will receive a biodegradable sponge (type I bovine collagen) to stabilize the clot

DRUG

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

PROCEDURE

cross mattress suture

The site will be stabilized with a simplet external, cross mattress suture

DRUG

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

DRUG

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

PROCEDURE

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)

OTHER

Photos/videos

subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.

PROCEDURE

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

PROCEDURE

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.

RADIATION

periapical xray

periapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point

OTHER

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.

Sponsors & Collaborators

• Gustavo Avila-Ortiz DDS, MS, PhD

  lead OTHER

Principal Investigators

• Brad Amendt, MS · UIowa College of Dentistry

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-31

Primary Completion

2030-09-30

Completion

2030-09-30

FDA Drug

Yes

Countries

• United States

Study Locations