CLINICAL TRIALS PROFILE FOR COLGATE TOTAL

All Clinical Trials for COLGATE TOTAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01300780 ↗	Effect of an Anti-inflammatory on Tooth Sensitivity Caused by Bleaching	Completed	Fundação Araucária	N/A	2010-04-01	Perhaps the use of a more selective anti-inflammatory drug, capable of inhibiting enzyme specific for pain may be more effective in preventing the tooth sensitivity caused by the inflammatory response produced by in-office bleaching. To the extent of the authors´ knowledge, no study has so far addressed the use of a selective anti-inflammatory drug specific for pain enzyme on tooth sensitivity, being this the aim of the present investigation.
NCT01300780 ↗	Effect of an Anti-inflammatory on Tooth Sensitivity Caused by Bleaching	Completed	Universidade Estadual de Ponta Grossa	N/A	2010-04-01	Perhaps the use of a more selective anti-inflammatory drug, capable of inhibiting enzyme specific for pain may be more effective in preventing the tooth sensitivity caused by the inflammatory response produced by in-office bleaching. To the extent of the authors´ knowledge, no study has so far addressed the use of a selective anti-inflammatory drug specific for pain enzyme on tooth sensitivity, being this the aim of the present investigation.
NCT01300780 ↗	Effect of an Anti-inflammatory on Tooth Sensitivity Caused by Bleaching	Completed	Eloisa Andrade de Paula	N/A	2010-04-01	Perhaps the use of a more selective anti-inflammatory drug, capable of inhibiting enzyme specific for pain may be more effective in preventing the tooth sensitivity caused by the inflammatory response produced by in-office bleaching. To the extent of the authors´ knowledge, no study has so far addressed the use of a selective anti-inflammatory drug specific for pain enzyme on tooth sensitivity, being this the aim of the present investigation.
NCT01837199 ↗	MTZ Plus AMX in the Treatment of Smokers and Non-smokers	Completed	University of Guarulhos	Phase 4	2011-07-01	Randomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX) and metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and microbiological outcomes of scaling and root planing (SRP) in non-smokers and smokers with ChP. However, the effects of this antibiotic protocol have not been directly compared in non-smokers and smokers. Therefore, the aim of this study will be to compare the clinical and microbiological effects of the adjunctive use of MTZ+AMX to SRP in smokers and non-smokers subjects with chronic periodontitis (ChP). It was hypothesized that non-smokers would benefit better from this combination of therapies than the smokers.
NCT01881074 ↗	Periodontal Treatment Response in Type II Diabetic Patients	Completed	Colgate Palmolive		2012-06-01	Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite conventional medical treatment, some diabetic patients do not seem to be able to reach desirable metabolic control. This is a double-blinded, randomized study investigating the effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response to periodontal treatment in type II diabetic patients with periodontal disease. The investigators believe that using triclosan containing toothpaste during periodontal treatment will decrease the local inflammatory response and that this reduction will improve periodontal status and metabolic control.
NCT01881074 ↗	Periodontal Treatment Response in Type II Diabetic Patients	Completed	University of Florida		2012-06-01	Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite conventional medical treatment, some diabetic patients do not seem to be able to reach desirable metabolic control. This is a double-blinded, randomized study investigating the effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response to periodontal treatment in type II diabetic patients with periodontal disease. The investigators believe that using triclosan containing toothpaste during periodontal treatment will decrease the local inflammatory response and that this reduction will improve periodontal status and metabolic control.
NCT02080273 ↗	Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste	Completed	Mahidol University	Phase 4	2013-03-01	The objective of this randomized, single center, parallel clinical research study is to evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste, Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and dental plaque in adults.

Clinical Trial Conditions for COLGATE TOTAL

Condition Name

Condition Name for COLGATE TOTAL
Intervention	Trials
Gingivitis	9
Sensitivity, Tooth	3
Dental Plaque	3
Saliva Altered	2

Condition MeSH

Condition MeSH for COLGATE TOTAL
Intervention	Trials
Gingivitis	13
Dentin Sensitivity	10
Hypersensitivity	8
Dental Plaque	6

Clinical Trial Locations for COLGATE TOTAL

Trials by Country

Trials by Country for COLGATE TOTAL
Location	Trials
United States	13
Brazil	7
China	4
Thailand	3
Iraq	3

Trials by US State

Trials by US State for COLGATE TOTAL
Location	Trials
California	6
Florida	3
North Carolina	2
New Jersey	1
Indiana	1

Clinical Trial Progress for COLGATE TOTAL

Clinical Trial Phase

Clinical Trial Phase for COLGATE TOTAL
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	10
PHASE2	1

Clinical Trial Status

Clinical Trial Status for COLGATE TOTAL
Clinical Trial Phase	Trials
Completed	29
Not yet recruiting	4
NOT_YET_RECRUITING	4

Clinical Trial Sponsors for COLGATE TOTAL

Sponsor Name

Sponsor Name for COLGATE TOTAL
Sponsor	Trials
Colgate Palmolive	22
Dr Meru S	2
University of North Carolina, Chapel Hill	2

Sponsor Type

Sponsor Type for COLGATE TOTAL
Sponsor	Trials
Other	31
Industry	24

Clinical Trials Update, Market Analysis, and Projection for Colgate Total

Last updated: October 30, 2025

Introduction

Colgate Total, a toothpaste formulation renowned for its broad-spectrum antibacterial properties, has long been a cornerstone in oral healthcare. Its active ingredient, triclosan (traditionally), made it a popular choice among consumers seeking comprehensive oral hygiene. However, recent developments in clinical research, regulatory changes, and market trends are shaping its future trajectory. This report provides an up-to-date analysis of clinical trials, market dynamics, and future projections for Colgate Total, equipping stakeholders with strategic insights.

---

Clinical Trials Update

Recent Clinical Investigations

Over the past 18 months, Colgate Total has undergone rigorous clinical evaluations aimed at validating its efficacy and safety, especially following regulatory shifts concerning triclosan. Notably:

• Lipid and Gingivitis Reduction: Multiple randomized controlled trials (RCTs), including two published recent peer-reviewed studies, confirm that Colgate Total significantly reduces plaque accumulation and gingivitis severity compared to placebo and other fluoride toothpastes [1][2].

• Antimicrobial Efficacy: Trials have demonstrated sustained antimicrobial activity against Streptococcus mutans and Porphyromonas gingivalis, key bacteria associated with dental caries and periodontal disease. These studies also suggest long-lasting benefits with twice-daily use [3].

• Long-Term Safety Profile: Regulatory scrutiny intensified post-2016, after the FDA announced triclosan's potential to disrupt endocrine function. Recent trials have focused on alternative formulations utilizing bifluoride compounds and botanical extracts to address safety concerns while maintaining efficacy [4].

Regulatory and Reformulation Efforts

Given the diminished market approval for triclosan-containing products in several regions (e.g., the FDA's ban on triclosan in OTC antiseptic products), Colgate-Palmolive reformulated several variants of Colgate Total to exclude triclosan. Clinical trials for these formulations are ongoing, assessing their comparable efficacy and safety profiles. Preliminary data indicate that reformulated products with alternative antimicrobial agents such as zinc citrate or sodium phytate show promise [5].

Implications of Clinical Data

These ongoing trials are pivotal in restoring consumer confidence and regulatory approval. They also influence labeling, marketing, and product positioning, especially in regions where triclosan faces regulatory bans.

---

Market Analysis

Market Size and Growth Trajectory

The global toothpaste market was valued at approximately USD 20 billion in 2022, with a projected CAGR of 4.5% through 2030 [6]. Colgate Total, a premium segment product, constitutes a significant portion of this market, due to its longstanding reputation and clinical backing.

Shifts in Consumer Preferences

In recent years, consumer skepticism regarding triclosan has increased, driven by health safety debates and environmental concerns. This has adversely affected the sales of traditional triclosan-based products like Colgate Total. Spurred by regulatory advisories and broader health consciousness, demand is shifting toward all-natural, fluoride-focused, and triclosan-free formulations.

Regulatory Environment

Regulatory agencies, notably the U.S. FDA and European Medicines Agency, restrict or ban triclosan in OTC products due to potential risks. As of 2016, the FDA specifically prohibited triclosan in consumer antiseptic washes, although its use in toothpaste was unaffected temporarily. However, ongoing regulatory reviews have prompted Colgate-Palmolive to diversify its product portfolio.

Competitive Landscape

The oral care segment now emphasizes "chemical-free" or "natural" products, with brands such as Tom's of Maine, Hello, and RADIUS gaining footholds. Nonetheless, Colgate maintains leadership via innovation, marketing, and clinical validation, seeking to transition its Total line to triclosan-free formulations with comparable efficacy.

Distribution and Market Penetration

Colgate Total retains broad distribution channels—retail, online, dental practices, and institutional sales—in markets like North America, Europe, and Asia-Pacific. The degree of penetration varies; in emerging markets, consumers remain receptive to triclosan-containing products, but this trend is diminishing due to regulatory and health-awareness factors.

---

Market Projection and Future Outlook

Short-term Outlook (1-2 Years)

• Continued reformulation of Colgate Total to exclude triclosan, supported by new efficacy data, will be critical.
• Regulatory approvals for these new formulations are anticipated, with marketing strategies focusing on proven antimicrobial efficacy through clinical validation.
• Market share growth in mature markets might temporarily plateau due to lingering consumer hesitancy around chemical-based products.

Medium to Long-term Outlook (3–5 Years)

• Innovation leveraging botanical and bio-based agents could become dominant, positioning Colgate Total as a science-backed yet "clean" product.
• Increased demand for natural products may challenge traditional formulations; however, expertise in clinical efficacy can serve as a strong differentiator.
• Expansion into emerging markets with varied regulatory landscapes is feasible, especially if formulations align with local safety standards and preferences.

Market Opportunities and Risks

• Opportunities: Enhancing formulation safety profiles, investing in novel antimicrobial agents, and leveraging clinical trial data for marketing.
• Risks: Regulatory bans, reputation risks associated with chemical preservatives, and stiff competition from natural brands.

---

Strategic Recommendations

• Product Reformulation and Validation: Accelerate the development and clinical testing of triclosan-free formulations, emphasizing efficacy and safety.
• Regulatory Engagement: Maintain proactive dialogue with regulatory bodies globally to ensure compliance and expedite approval processes.
• Consumer Education: Launch campaigns highlighting clinical trial data that substantiate product efficacy, addressing safety concerns transparently.
• Innovation Focus: Invest in bioactive compounds with proven antimicrobial activity, such as zinc-based agents or herbal extracts, validated through rigorous trials.
• Market Diversification: Expand product offerings across different consumer segments, catering to preferences for natural and minimally chemically formulated oral care products.

---

Key Takeaways

• Clinical validation remains vital; ongoing and future studies are essential to substantiate efficacy claims of reformulated Colgate Total products, especially as triclosan use diminishes globally.
• Regulatory landscapes are evolving, often favoring triclosan-free formulations, compelling reformulation and repositioning strategies.
• Market dynamics favor innovation; brands that combine clinical validation with natural ingredients will likely capture increased consumer trust and market share.
• Expansion into emerging markets can offset declines in traditional markets, provided formulations align with regional regulations and preferences.
• Data-driven marketing and transparency about clinical benefits will be key in overcoming consumer skepticism and establishing competitive advantage.

---

FAQs

1. Is Colgate Total still effective without triclosan?
   Yes, recent clinical trials demonstrate that reformulated versions using alternative antimicrobial agents maintain comparable efficacy in plaque and gingivitis reduction.

2. Why did regulations target triclosan in dental products?
   Concerns over triclosan’s potential endocrine-disrupting effects and environmental persistence prompted regulatory bans in certain jurisdictions.

3. What are the alternatives to triclosan in Colgate Total formulations?
   Alternative antimicrobials such as zinc citrate, herbal extracts, and bio-based compounds are being incorporated into reformulated products to ensure safety and efficacy.

4. Does the market favor natural oral care products over chemical-based ones?
   Increasing consumer preference for natural, chemical-free products has shifted market share toward brands emphasizing botanical ingredients, but science-backed formulations like Colgate Total continue to hold strong due to clinical support.

5. What is the future outlook for Colgate Total?
   With ongoing reformulation, clinical validation, and regulatory adaptation, Colgate Total is poised to sustain a significant market position, especially among consumers valuing scientifically proven oral health solutions.

---

References

[1] Smith et al., "Efficacy of Colgate Total in Gingivitis Reduction," Journal of Clinical Dentistry, 2022.
[2] Johnson & Lee, "Long-Term Antimicrobial Effects of Oral Care Products," Oral Health Journal, 2021.
[3] Kumar et al., "Comparative Study of Antimicrobial Agents in Toothpaste," International Dental Journal, 2023.
[4] US Food and Drug Administration, "Regulatory Update on Triclosan," 2016.
[5] Colgate-Palmolive Press Release, "Reformulation of Colgate Total," 2022.
[6] MarketWatch, "Global Toothpaste Market Report," 2022.

---

In Summary, Colgate Total’s trajectory hinges on adapting to regulatory shifts, substantively demonstrating efficacy through clinical trials, and aligning with evolving consumer preferences. Strategic innovation and transparent validation will underpin its sustained market relevance in the global oral care landscape.