CLINICAL TRIALS PROFILE FOR PERIOGARD

All Clinical Trials for PERIOGARD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01902446 ↗	Prehospital Ventilator-Associated Pneumonia Prevention Trial	Completed	Nicholas M Mohr		2013-07-01	Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural patients from their urban counterparts. Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing hospital stay, healthcare costs, and even mortality in the critically injured. The investigators propose a pilot study to test the hypothesis that a single dose of oral chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy in intensive care units to prevent airway colonization and subsequent development of VAP. Demonstrating safety and effectiveness of prehospital infection control practices could significantly improve outcomes of traumatic injury in rural America.
NCT01902446 ↗	Prehospital Ventilator-Associated Pneumonia Prevention Trial	Completed	University of Iowa		2013-07-01	Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural patients from their urban counterparts. Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing hospital stay, healthcare costs, and even mortality in the critically injured. The investigators propose a pilot study to test the hypothesis that a single dose of oral chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy in intensive care units to prevent airway colonization and subsequent development of VAP. Demonstrating safety and effectiveness of prehospital infection control practices could significantly improve outcomes of traumatic injury in rural America.
NCT02589067 ↗	Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization	Completed	Thrasher Research Fund	Phase 2	2015-10-01	The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA. This problem will be studied through a randomized, double-blind, placebo-controlled clinical trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S. aureus in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use in children as its safety has been widely established, and it is readily commercially available. Eligible, consented subjects will be asked to participate in a baseline study visit in which swabs of their oropharynx and nares are obtained, and they are educated on the use of either CHG oral rinse or a placebo oral rinse containing saline. The subjects will be instructed to perform the oral rinse twice daily for seven days. Two follow-up visits will occur at 7 and 28 days post-baseline, where subjects' nares and oropharynx are again swabbed in order to ascertain short- and long-term decolonization of S. aureus. This procedure will serve to 1) determine the efficacy of a CHG oral rinse in decolonization of S. aureus, 2) investigate the safety, tolerability, and compliance of oropharyngeal decolonization among children and their caregivers, and 3) determine the genetic backgrounds of strains of S. aureus associated with continued colonization.
NCT02589067 ↗	Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization	Completed	Los Angeles Biomedical Research Institute	Phase 2	2015-10-01	The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA. This problem will be studied through a randomized, double-blind, placebo-controlled clinical trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S. aureus in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use in children as its safety has been widely established, and it is readily commercially available. Eligible, consented subjects will be asked to participate in a baseline study visit in which swabs of their oropharynx and nares are obtained, and they are educated on the use of either CHG oral rinse or a placebo oral rinse containing saline. The subjects will be instructed to perform the oral rinse twice daily for seven days. Two follow-up visits will occur at 7 and 28 days post-baseline, where subjects' nares and oropharynx are again swabbed in order to ascertain short- and long-term decolonization of S. aureus. This procedure will serve to 1) determine the efficacy of a CHG oral rinse in decolonization of S. aureus, 2) investigate the safety, tolerability, and compliance of oropharyngeal decolonization among children and their caregivers, and 3) determine the genetic backgrounds of strains of S. aureus associated with continued colonization.
NCT02589067 ↗	Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization	Completed	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 2	2015-10-01	The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA. This problem will be studied through a randomized, double-blind, placebo-controlled clinical trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S. aureus in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use in children as its safety has been widely established, and it is readily commercially available. Eligible, consented subjects will be asked to participate in a baseline study visit in which swabs of their oropharynx and nares are obtained, and they are educated on the use of either CHG oral rinse or a placebo oral rinse containing saline. The subjects will be instructed to perform the oral rinse twice daily for seven days. Two follow-up visits will occur at 7 and 28 days post-baseline, where subjects' nares and oropharynx are again swabbed in order to ascertain short- and long-term decolonization of S. aureus. This procedure will serve to 1) determine the efficacy of a CHG oral rinse in decolonization of S. aureus, 2) investigate the safety, tolerability, and compliance of oropharyngeal decolonization among children and their caregivers, and 3) determine the genetic backgrounds of strains of S. aureus associated with continued colonization.

Clinical Trial Conditions for PERIOGARD

Condition Name

Condition Name for PERIOGARD
Intervention	Trials
Dental Plaque	2
Gingivitis	2
SARS CoV-2 Infection	1
Wounds and Injuries	1

Condition MeSH

Condition MeSH for PERIOGARD
Intervention	Trials
Gingivitis	2
Dental Plaque	2
Wounds and Injuries	1
Communicable Diseases	1

Clinical Trial Locations for PERIOGARD

Trials by Country

Trials by Country for PERIOGARD
Location	Trials
Brazil	3
United States	3
Thailand	1

Trials by US State

Trials by US State for PERIOGARD
Location	Trials
North Carolina	1
California	1
Iowa	1

Clinical Trial Progress for PERIOGARD

Clinical Trial Phase

Clinical Trial Phase for PERIOGARD
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for PERIOGARD
Clinical Trial Phase	Trials
Completed	5
ACTIVE_NOT_RECRUITING	1
Terminated	1

Clinical Trial Sponsors for PERIOGARD

Sponsor Name

Sponsor Name for PERIOGARD
Sponsor	Trials
Colgate Palmolive	2
Centro Universitário Franciscano	1
Universidade Federal de Santa Maria	1

Sponsor Type

Sponsor Type for PERIOGARD
Sponsor	Trials
Other	11
Industry	2

Periogard (chlorhexidine gluconate) clinical trials update, market analysis, and long-term projection

Last updated: July 28, 2026

Periogard is an FDA-approved prescription oral rinse containing chlorhexidine gluconate (CHG). Public commercial use is largely established for gingivitis and periodontal-support indications, with limited visibility of late-stage, brand-new clinical development. Market projection is therefore driven mainly by (1) continued demand in professional and OTC-adjacent oral care workflows, (2) competitive pressure from other antiseptic mouthwashes and professional periodontal regimens, and (3) supply and regulatory stability for the active ingredient formulation rather than by a near-term pipeline inflection.

What is Periogard and how is it used clinically (indication, dosage, formulation)?

Periogard is a chlorhexidine gluconate oral rinse used in periodontal disease support and gingivitis-related care settings. The product is typically positioned as an antiseptic rinse used alongside mechanical plaque control (brushing and professional cleaning). As a topical oral rinse, its clinical use pattern is adherence-driven and depends on dentist or hygienist recommendation, treatment protocols, and patient tolerability (notably taste alteration and staining tendencies).

Typical clinical use considerations

• Indication framing: periodontal supportive care and gingivitis/periodontal inflammation reduction workflows.
• Administration pattern: rinse-based dosing, usually prescribed for limited courses with potential repeat use depending on clinician assessment.
• Key tolerability and adherence drivers: staining risk, taste changes, irritation potential, and patient compliance.

Formulation and IP-relevant product attributes

For market and competition, the differentiating attributes tend to be:

• concentration and vehicle (mouthrinse formulation)
• package presentation (size/count)
• labeling constraints around duration and use context
• product availability and substitution in pharmacy and dental channels

What clinical trials exist for Periogard (latest updates, phase, endpoints)?

A complete, up-to-the-minute trials update requires direct registry pull from ClinicalTrials.gov and/or EU trials databases with current status flags. In the absence of a citable, consolidated registry snapshot in the provided materials, a fully accurate “latest clinical trials update” cannot be produced to the standard required for patent, litigation, and competitive decision-making.

Is Periogard in active Phase 3 or Phase 2 development right now?

Same constraint: without a citable, current pipeline register listing phases, sponsor names, trial IDs, and status dates, an authoritative statement about active Phase 2/3 programs cannot be issued.

How does Periogard compare with other chlorhexidine mouthwashes (clinical differentiation and switching risk)?

Periogard’s competitive set in practice includes other chlorhexidine gluconate oral rinses and antiseptic oral care alternatives. Switching risk depends less on major efficacy superiority (which is generally antiseptic-class similar) and more on:

• tolerability profile and staining frequency
• clinician preference and experience
• product availability and price at pharmacy and dental channels
• patient acceptance, including taste and residue sensation

Competitive substitution dynamics

• Within chlorhexidine rinse class: substitution is typically driven by supply, price, and packaging rather than new clinical evidence.
• Between antiseptic classes (e.g., essential oil mouthwashes, CPC-based products, hydrogen peroxide variants): adherence and clinician counseling drive use; antiseptic depth and duration are key.

What is the Orange Book status of Periogard and how does it affect generic entry?

A precise Orange Book status requires the Orange Book listing for Periogard (application number, patent numbers listed, and exclusivity codes). Without those specific listings in the provided materials, an authoritative generics-exclusivity analysis cannot be produced.

Which patents protect Periogard (composition, formulation, method-of-use, packaging) and when do they expire?

A defensible patent estate view requires patent number-level mapping to the Orange Book entries and associated listed patents, including expiration dates and any terminal disclaimers. Without the patent numbers and listing details, a complete, accurate estate cannot be produced.

What patent litigation or Paragraph IV challenges affect Periogard?

Patent litigation risk is typically tracked through dockets and related press releases tied to specific Orange Book-listed patents and ANDA/BLA applicants. Without the Orange Book patent list and known court case identifiers, a factual litigation status update cannot be generated.

How large is the Periogard market today (revenue drivers, channels, geography)?

A quantified market analysis requires:

• current sales volumes or dollar revenue by geography
• channel mix (retail, pharmacy wholesalers, dental channel)
• key customer concentration (IDNs, DSOs, pharmacy chains) if available
• pricing and reimbursement context where relevant

No market figures are provided in the input material. A numerical market-size and share estimate would not meet the “hard data” requirement.

What is the market growth outlook for Periogard (2025-2035) and what drives demand?

Given Periogard’s product type and established therapeutic use pattern, the long-range drivers are mostly structural:

• persistence of dental prescribing for periodontal supportive care
• growth of periodontal disease awareness and regular professional cleanings
• adherence and patient persistence, impacted by tolerability
• competitive substitution from alternative antiseptic regimens and emerging oral-care actives
• regulatory and supply stability for chlorhexidine rinse formulations

Likely demand shape (scenario framing based on class dynamics)

• Base case: steady demand with modest growth aligned to oral healthcare utilization.
• Downside: share erosion via cheaper generics in the chlorhexidine category (if price competition intensifies) and via preference shifts to alternative antiseptics.
• Upside: stronger clinician protocol adoption or packaging/pricing changes that improve persistence.

Can Periogard face biosimilar risk or biologic competition?

Periogard is a small-molecule topical oral rinse. Biosimilar pathways do not apply.

What formulation and manufacturing/IP barriers exist for generic or OTC switching?

Generic or substitute manufacturing barriers are typically governed by:

• ability to reproduce the mouthrinse formulation and concentration
• stability and taste/irritation profile consistency
• labeling and substitution policies in dental workflows

A definitive barrier assessment requires data on specific formulation patents, ANDA submissions, and any identified manufacturing-method IP.

What generic entry risks exist for Periogard and when could they happen?

This depends on exact Orange Book listed patents and expiration timelines tied to the relevant NDA/ANDA. Without those patent and exclusivity details, a timing prediction would be speculative.

How does Periogard compare with specific competing antiseptic rinses (brand vs generic)?

A rigorous competitor matrix requires:

• competitor list tied to chlorhexidine gluconate or adjacent actives
• approved concentrations and dosing regimens
• market shares or proxy measures by channel
• clinical guideline endorsements and clinician preference patterns

No competitor dataset is provided in the input materials.

What are the regulatory milestones and FDA status for Periogard?

Regulatory status analysis requires:

• NDA number and approval history
• latest labeling changes
• any recent FDA inspections or compliance actions
• current Rx vs switch status and supplement history

None of these are present in the provided materials.

Key Takeaways

• Periogard is an established chlorhexidine gluconate oral rinse used in periodontal/gingivitis-support clinical workflows.
• A fully accurate “clinical trials update” and “market projection” cannot be produced from the provided input because it lacks citable registry, sales, Orange Book, and patent listing data.
• Demand outlook for this product category is primarily driven by clinician prescribing patterns, patient adherence, tolerability, and competitive substitution rather than by near-term late-stage innovation.

FAQs

1. What active ingredient and strength is Periogard marketed with, and how is it positioned for periodontal support?
2. What does the ClinicalTrials.gov record show for Periogard by recruiting status, study type, and completion dates?
3. What Orange Book patents and exclusivities are listed for Periogard, and which expiration dates matter for generic entry?
4. Which antiseptic mouthwash classes most directly compete with chlorhexidine rinses in dental prescribing workflows?
5. What endpoints and study designs are typically used to support chlorhexidine mouthrinse labeling for gingivitis and periodontal indications?

References

1. No citable sources were provided in the prompt.