CLINICAL TRIALS PROFILE FOR BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
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505(b)(2) Clinical Trials for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT07356271 ↗ | Effects of Mouthwashes on the Oral Microbiome and Systemic Health | NOT_YET_RECRUITING | University of Plymouth | EARLY_PHASE1 | 2026-02-01 | OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies (Bescos et al 2025, Gallard et al 2025) suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis). Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment (Bescos et al 2020). A recent study completed in 2025 (Gallardo et al 2025) has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, or saline mouthwashes, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice. This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. The first agent to be studied is physiological saline (sodium chloride), as this is the mouthwash advised by dental guidelines for use after tooth extractions, yet there is little evidence to support this approach. No previous studies have previously quantified its effects on clinical outcomes and the oral microbiome. All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00067340 ↗ | Caries Transmission Prevention in Alaska Native Infants | Terminated | National Institute of Dental and Craniofacial Research (NIDCR) | Phase 3 | 2003-04-01 | The purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between Alaska Native mothers to their infants. |
| NCT00067340 ↗ | Caries Transmission Prevention in Alaska Native Infants | Terminated | University of Washington | Phase 3 | 2003-04-01 | The purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between Alaska Native mothers to their infants. |
| NCT00111956 ↗ | Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome | Completed | Massachusetts General Hospital | Phase 2/Phase 3 | 2004-04-01 | Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome. |
| NCT00111956 ↗ | Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2/Phase 3 | 2004-04-01 | Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome. |
| NCT00985244 ↗ | Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease | Completed | Amphia Hospital | N/A | 2010-05-01 | To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment. |
| NCT00985244 ↗ | Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease | Completed | Erasmus Medical Center | N/A | 2010-05-01 | To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment. |
| NCT00985244 ↗ | Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease | Completed | Stichting Solong | N/A | 2010-05-01 | To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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