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About
This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age. NV-101 or sham injection is administered at the completion of a dental procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental procedure(s) shall be performed in a single quadrant of the mouth and include cavity preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing), or crowns.
Sex
Ages
Volunteers
Inclusion criteria
Male or female, 4 to 11 years of age
Sufficiently healthy, as determined by the Investigator, to receive routine dental care
Requires a restorative procedure such as cavity preparation, or such as teeth cleaning (non-surgical scaling and/or root planing) in a single quadrant of the mouth
Requires local anesthesia with 2% lidocaine with 1:100,000 epinephrine administered by submucosal injection
Dental procedure(s) completed with 60 minutes of injection of local anesthetic
Can be trained to complete the Wong Baker Pain Rating Scale
For subjects 6 to 11 years of age who are trainable in standardized palpation procedure:
Negative urine pregnancy test at screening in female subjects who are past menarche
Subjects give written or verbal assent, as applicable, and parents(s) or legal guardian(s) give written informed consent
Exclusion criteria
Primary purpose
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Interventional model
Masking
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Data sourced from clinicaltrials.gov
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