---
title: Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
nct_id: NCT01024738
overall_status: COMPLETED
phase: PHASE3
sponsor: Colgate Palmolive
study_type: INTERVENTIONAL
primary_condition: Dental Plaque
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01024738.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01024738"
ct_last_update_post_date: 2009-12-03
last_seen_at: "2026-05-12T07:31:12.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

**NCT ID:** [NCT01024738](https://clinicaltrials.gov/study/NCT01024738)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 22
- **Lead Sponsor:** Colgate Palmolive
- **Conditions:** Dental Plaque
- **Start Date:** 2008-03
- **Completion Date:** 2008-04
- **CT.gov Last Update:** 2009-12-03

## Brief Summary

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

## Detailed Description

Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Be aged 18 to 65 years inclusive
* Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
* Give written informed consent
* Be in good general health
* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
* If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

* Medical condition which requires pre-medication (antibiotics) prior to dental
* Visits/procedures
* Allergy to chlorhexidine
* Advanced periodontal disease (gum disease)
* 5 or more decayed, untreated dental sites (cavities)
* Diseases of the soft or hard oral tissues (gums or palate)
* Orthodontic appliances that interfere with plaque rating
* Abnormal salivary function
* Use of drugs that can affect currently salivary flow or production
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)
* Pregnant or breastfeeding.
* Participation in another research study in the month preceding this study
* Allergic to common toothpaste or mouth rinse ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
```

## Arms

- **Fluoride toothpaste** (PLACEBO_COMPARATOR) — negative control toothpaste
- **Triclosan/Fluoride toothpaste** (ACTIVE_COMPARATOR) — positive control toothpaste (Total toothpaste)
- **Chlorhexidine Oral Rinse** (ACTIVE_COMPARATOR) — positive control oral rinse

## Interventions

- **Fluoride** (DRUG) — Brush half mouth twice daily for four days.
- **Triclosan, fluoride** (DRUG) — Brush twice daily
- **Chlorhexidine Gluconate** (DRUG) — Rinse mouth twice a day

## Primary Outcomes

- **Plaque Index** _(time frame: 4 Days)_ — Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

## Locations (1)

- TKL Research, Inc., Paramus, New Jersey, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tkl research, inc.|paramus|new jersey|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01024738.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01024738*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*