MicroRNA and MicroRNA Inhibitors Socket Study, Pilot Clinical Trial

Withdrawn before enrolling · Phase 1

Conditions studied: Tooth Extraction Status Nos

In brief

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.

Key facts

Study ID

NCT02579187

Run by

Gustavo Avila-Ortiz DDS, MS, PhD

People needed

0

Starts

2025-12-31

Expected to finish

2030-09-01

Last updated by the study team

2019-07-17

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• UIowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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