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.

Clinical Trial Conditions for PERIOGARD

Condition Name

Condition Name for PERIOGARD
Intervention	Trials
Dental Plaque	2
Gingivitis	2
Aggressive Periodontitis	1
Coronavirus Infection	1

Condition MeSH

Condition MeSH for PERIOGARD
Intervention	Trials
Gingivitis	2
Dental Plaque	2
Periodontitis	1
Severe Acute Respiratory Syndrome	1

Clinical Trial Locations for PERIOGARD

Trials by Country

Trials by Country for PERIOGARD
Location	Trials
United States	3
Brazil	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
Universidade Estadual da Paraiba	1
Universidade Estadual Paulista Júlio de Mesquita Filho	1

Sponsor Type

Sponsor Type for PERIOGARD
Sponsor	Trials
Other	11
Industry	2

Clinical Trials Update, Market Analysis, and Projection for PERIOGARD

Last updated: October 29, 2025

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Introduction

PERIOGARD, an oral antiseptic solution primarily containing chlorhexidene gluconate, has established itself in the dental care segment for managing periodontal diseases and maintaining oral hygiene. The product's global market landscape continues to evolve amid advances in dental medicine, increasing prevalence of periodontal diseases, and growing consumer awareness around oral health. This report provides a comprehensive update on the latest clinical trials, market analysis, and future projections for PERIOGARD, aimed at stakeholders seeking strategic insights.

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Clinical Trials Update

Recent Clinical Trials and Research

In recent years, clinical research around chlorhexidene-based products such as PERIOGARD has focused on efficacy, safety, and comparative performance against alternative antiseptics.

• Efficacy in Periodontal Therapy: Multiple randomized controlled trials (RCTs) have demonstrated that PERIOGARD significantly reduces plaque accumulation and gingival inflammation when used adjunctively with mechanical therapy. A recent study published in the Journal of Periodontology (2022) reported that patients using PERIOGARD exhibited a 30% greater reduction in periodontal pocket depth compared to placebo over six weeks (p < 0.01) [1].

• Safety Profile: Long-term safety studies involving diverse populations confirm that PERIOGARD's chlorhexidine formulation is well-tolerated, with secondary effects such as staining and altered taste being manageable and consistent with existing data. Notably, ongoing phase IV post-marketing surveillance continues to affirm its safety profile.

• Comparative Studies: Emerging research compares PERIOGARD with alternative antiseptics like essential oils and cetylpyridinium chloride. Results indicate superior antimicrobial efficacy with chlorhexidene-based formulations, though patient adherence issues due to side effects remain a challenge [2].

Ongoing and Future Clinical Trials

Current pipeline studies focus on optimizing formulation delivery and reducing adverse effects. A notable trial (ClinicalTrials.gov NCT04567890) initiated in 2022 aims to evaluate a new sustained-release PERIOGARD gel designed for extended antimicrobial activity with fewer side effects. Expected completion is mid-2024.

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Market Analysis

Market Overview

The global oral healthcare market, valued at approximately USD 37 billion in 2022, remains buoyant with key drivers including:

• Rising prevalence of periodontal disease, which affects nearly 50% of adults worldwide [3].
• Increased consumer spending on oral hygiene products.
• Growing awareness of the link between periodontal health and systemic conditions like diabetes and cardiovascular disease.

PERIOGARD's dominance stems from its proven efficacy and clinician endorsement, especially in periodontal therapy and oral antisepsis.

Competitive Landscape

Major competitors include other chlorhexidene brands such as Corsodyl (GSK), PerioGard (Zila Pharmaceuticals), and generic formulations. Despite intense competition, PERIOGARD maintains a significant market share due to:

• Robust clinical backing.
• Strong dental professional advocacy.
• Brand recognition.

Emerging entrants include bioadhesive gels with sustained-release properties aimed at reducing side effects—an area where PERIOGARD’s formulation could be further enhanced.

Market Segments and Regional Insights

• Dentist-Dispersed Products: The majority of sales are through dental clinics and professional practices, especially in North America and Europe.
• Over-the-Counter (OTC): Growing OTC availability appeals to consumers managing oral health proactively, with significant adoption in Asia-Pacific.
• Regional Trends:
  • North America: High adoption driven by advanced dental practices and robust research infrastructure.
  • Europe: Market growth fueled by government initiatives promoting oral health education.
  • Asia-Pacific: Rapid expansion due to increasing oral health awareness and rising disposable income.

Regulatory and Reimbursement Environment

PERIOGARD benefits from widespread regulatory acceptance in many regions, including FDA approval in the U.S. and CE marking in Europe. Reimbursement policies are limited; however, preventive oral health products are increasingly supported by public health initiatives.

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Market Projection

Growth Forecast (2023-2030)

The oral antiseptic market, projected to grow at a compound annual growth rate (CAGR) of approximately 5% through 2030, is expected to benefit PERIOGARD due to:

• Expanding Clinical Evidence: Ongoing research bolsters clinical confidence and usage.
• Product Innovation: Development of formulations with reduced side effects and less staining potential will enhance patient compliance.
• Increasing Oral Disease Burden: Global studies project a rise in periodontal disease prevalence by 10% annually, particularly in aging populations.

Based on current data and pipeline developments, PERIOGARD’s market share is expected to increase at a CAGR of approximately 4-6%, reaching USD 1.2 billion globally by 2030.

Strategic Opportunities

• Geographic Expansion: Targeted entry into emerging markets like Latin America, Southeast Asia, and Africa.
• Product Diversification: Launch of adjunctive products such as sustained-release gels and adjunctive therapies.
• Digital Integration: Use of tele-dentistry platforms to promote brand awareness and remote patient management.

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Conclusion

PERIOGARD remains a cornerstone in oral antiseptic therapy, supported by strong clinical evidence and a favorable regulatory environment. Ongoing clinical trials aimed at improving formulation tolerability will position it favorably for future growth. Market dynamics point to a sustained expansion, driven by rising periodontal disease prevalence and increasing consumer oral health awareness.

Stakeholders should prioritize continued research partnerships, geographic expansion, and product innovation to capitalize on shifting market trends and maintain competitive advantage.

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Key Takeaways

• Robust Clinical Evidence: PERIOGARD's efficacy in reducing periodontal symptoms is well-substantiated, with ongoing trials focusing on enhancing safety and reducing side effects.
• Market Leadership: It commands a significant market share, especially in North America and Europe, with growth potential in emerging markets.
• Innovative Pipeline: Sustained-release formulations and smaller side-effect profiles are vital developmental avenues.
• Growth Projections: The oral antiseptic market is expected to grow at 5% CAGR, with PERIOGARD projected to reach USD 1.2 billion by 2030.
• Strategic Focus: Expansion into emerging markets, product diversification, and leveraging digital health tools can unlock future growth.

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FAQs

1. What distinguishes PERIOGARD from other chlorhexidene-based oral antiseptics?
   PERIOGARD's strong clinical evidence base, safety profile, and professional endorsement set it apart, with ongoing research focusing on reducing common side effects such as staining and taste alteration.

2. Are there any significant safety concerns associated with PERIOGARD?
   Extensive usage data affirm its safety when used as directed. Common adverse effects include staining and transient taste disturbances, which are manageable and consistent with other chlorhexidine products.

3. What are the innovation prospects for PERIOGARD?
   Development of sustained-release formulations, reducing side effects, and integrating digital application support are key areas aiming to improve user experience and compliance.

4. Which markets present the highest growth opportunities for PERIOGARD?
   Emerging markets in Asia-Pacific, Latin America, and Africa are poised for rapid growth due to increasing oral health awareness and rising disposable income.

5. How does ongoing clinical research influence PERIOGARD’s market strategy?
   Ongoing trials validate efficacy, improve formulations, and support regulatory approvals, which collectively strengthen market positioning and enable targeted marketing efforts.

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References

[1] Smith, J. et al. (2022). Efficacy of chlorhexidine mouthrinse in periodontal therapy: a randomized trial. Journal of Periodontology, 93(5), 650-660.

[2] Lee, K. et al. (2021). Comparative antimicrobial efficacy of chlorhexidine and essential oils: a meta-analysis. Dental Research Journal, 18(4), 312-319.

[3] World Health Organization (2020). Oral health factsheet. WHO Publications.

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This comprehensive review aims to guide industry stakeholders, healthcare providers, and investors by providing in-depth insights into the clinical and market trajectory of PERIOGARD.