In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

In Vivo Assessment of Silver Biomaterial Nano-Toxicity

NCT01243320

Healthy

COMPLETED PHASE1/PHASE2

Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use

NCT05950529

Oral Malodor

COMPLETED NA

Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste

NCT02992314

Medication Associated Metallic Taste , Dysgeusia

COMPLETED NA

Study to Evaluate the Efficacy of Bite's Natural Deodorant

NCT05503784

Sweat Underarm Odor

COMPLETED NA

An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness

NCT01369589

Xerostomia Sjogren's Syndrome

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

32ppm Oral Silver

14 Days Active Silver Solution

Group Type EXPERIMENTAL

32ppm Silver Particle

Intervention Type DRUG

Oral silver dose of 32ppm

Sterile Water

No Silver Nanoparticles

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sterile Water No Silver

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

32ppm Silver Particle

Oral silver dose of 32ppm

Intervention Type DRUG

Placebo

Sterile Water No Silver

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-80 years old without debilitating chronic disease or history of cardiovascular event.

Exclusion Criteria

* Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control;
* Any female who is nursing;
* History of heavy metal allergy;
* History of asthma or Chronic Obstructive Pulmonary Disease;
* History of renal impairment;
* Symptoms of active upper respiratory disease at time of consent;
* Smoking more than 5 cigarettes or equivalent and not able to stop for 48 hours;
* Ability to discontinue chronic medications or nutraceuticals for 20 days or 5 half-lives of the agent, whichever is longer.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes