Phase 3 N=39 Randomized Single-blind Treatment

Collection of Gingival Crevicular Fluid From Periodontitis Patients

Gingival Diseases

Bottom Line

View on ClinicalTrials.gov: NCT00763048 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcome: Primary: Metabolite Associated With Inflammation (Cadaverine) — 1.119186; 0.92077 ion count — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fluoride (Drug); Fluoride, triclosan (Drug)
Age: Adult, Older Adult · 26+ yrs
Sex: All
Sponsor: Colgate Palmolive
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Metabolite Associated With Inflammation (Cadaverine)	1.119186; 0.92077	<0.05 sig
PRIMARY Metabolite Associated With Inflammation (Choline)	1.2264; 1.169513	<0.05 sig
PRIMARY Metabolite Associated With Inflammation (Hypoxanthine)	0.76984; 0.701628	<0.05 sig
PRIMARY Metabolite Associated With Inflammation (Inosine)	1.11183; 0.84462	0.05
PRIMARY Metabolite Associated With Inflammation (Isoleucine)	1.20033; 1.048449	0.05
PRIMARY Metabolite Associated With Inflammation (Leucine)	1.10064; 1.018989	0.05
PRIMARY Metabolite Associated With Inflammation (Lysine)	1.063873; 1.09704	0.05
PRIMARY Metabolite Associated With Inflammation (Phenylalanine)	1.16994; 1.057373	0.05
PRIMARY Metabolite Associated With Inflammation (Putrescine)	1.050398; 0.74134	0.05
PRIMARY Metabolite Associated With Inflammation (Xanthine)	1.05189; 1.011732	—

Summary

To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.

Eligibility Criteria

Inclusion Criteria

Be aged 18 to 65 years inclusive
Have a minimum of 20 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

Exclusion Criteria

Medical condition which requires pre-medication prior to dental visits/procedures
Advanced periodontal disease
5 or more decayed, untreated dental sites
Diseases of the soft or hard oral tissues
Orthodontic appliances
Abnormal salivary function
Use of prescription drugs.
Use of antibiotics one (1) month prior to or during this study
Use of any over the counter medications other than analgesics
Erratic use of vitamin supplements
Pregnant or breastfeeding.
Participation in another clinical study in the month preceding this study
Allergic to common dentifrice ingredients
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00763048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.