Clinical trial NCT02670135: Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
Official title: Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Disease
Systemic Inflammatory Markers
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single center, double blinded, randomized, controlled trial. Qualified subjects will be enrolled and randomized to either one of the two study groups: a) using 0.3% triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice (copolymer/fluoride/no triclosan) twice daily.

Detailed description: The objective of this study is to comparatively evaluate the effects of Colgate Total® toothpaste with triclosan (commercially sold in Israel) and triclosan-free matching placebo toothpaste on markers of inflammation in the bloodstream and to correlate these findings with periodontal disease status in the oral cavity, as determined by the parameters assessed. Periodontal parameters (periodontal pocket dept (PPD), Clinical Attachment loss (CAL)) will be assessed at baseline and after 2, 6 and 12 months of product use. Peripheral blood samples will be drawn from the subjects at baseline and after 2, 6 and 12 months to evaluate the effects of tooth brushing on systemic inflammatory markers (CRP, PGE2, IL-1β, TNF-α).

Eligibility criteria: Inclusion Criteria:

1. Subject males or females 18 to 50 years old.
2. Availability for the 12 months duration of the clinical research study.
3. Subject able and willing to follow study procedures and instructions.
4. Subject read, understood and signed an informed consent form.
5. Subject present with at least 20 natural teeth in the functional dentition (excluding third molars).
6. Initial probing pocket depth of \>4mm in at least one tooth/quadrant.
7. Good general health.
8. Subjects willing to disclose information on medication.

Exclusion Criteria:

1. Subject with concomitant periodontal therapy 6 months prior to enrollment.
2. Subject with orthodontic appliances.
3. Subject chronically treated (i.e. two weeks or more) with any medication known to affect inflammation or periodontal status or within one month of the first examination\*.
4. Subject treated with antibiotics within 3 months prior to enrollment.
5. Subject necessitating antibiotic prophylaxis.
6. Subject with active infectious diseases (hepatitis, human immunodeficiency virus or Tuberculosis) or subject is immunocompromised as determined by the Investigator\*.
7. Subject with known allergy to oral care products or ingredients in oral care products.
8. Subject with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity (determined by the examiner).
9. Subject diagnosed with aggressive periodontitis or acute necrotizing ulcerative gingivitis.
10. Participation in any other clinical study or test panel within the one month prior to entry into the study.
11. Subject pregnant at point of enrollment.

Primary outcomes:
measure: Periodontal Pocket Depth (PPD)
timeFrame: baseline
measure: Periodontal Pocket Depth (PPD)
timeFrame: 2 months
measure: Periodontal Pocket Depth (PPD)
timeFrame: 6 months
measure: Periodontal Pocket Depth (PPD)
timeFrame: 12 months
measure: Clinical Attachment Loss (CAL)
timeFrame: baseline
measure: Clinical Attachment Loss (CAL)
timeFrame: 2 months
measure: Clinical Attachment Loss (CAL)
timeFrame: 6 months
measure: Clinical Attachment Loss (CAL)
timeFrame: 12 months
measure: C Reactive Protein (CRP)
timeFrame: baseline
measure: C Reactive Protein (CRP)
timeFrame: 2 months
measure: C Reactive Protein (CRP)
timeFrame: 6 months
measure: C Reactive Protein (CRP)
timeFrame: 12 months
measure: Interleukin-1 Beta ( IL-1β)
timeFrame: baseline
measure: Interleukin-1 Beta (IL-1β)
timeFrame: 2 months
measure: Interleukin-1 Beta (IL-1β)
timeFrame: 6 months
measure: Interleukin-1 Beta (IL- 1β)
timeFrame: 12 months
measure: Tumor necrosis factor - alfa (TNF-α)
timeFrame: baseline
measure: Tumor necrosis factor - alfa (TNF-α)
timeFrame: 2 months
measure: Tumor necrosis factor - alfa (TNF-α)
timeFrame: 6 months
measure: Tumor necrosis factor - alfa (TNF-α)
timeFrame: 12 months
measure: Prostaglandin E2 (PGE 2)
timeFrame: baseline
measure: Prostaglandin E2 (PGE 2)
timeFrame: 2 months
measure: Prostaglandin E2 (PGE 2)
timeFrame: 6 months
measure: Prostaglandin E2 (PGE 2)
timeFrame: 12 moths
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: