Dental Plaque, Gingivitis
Conditions
Keywords
plaque, gingivitis, Loe and Silness Gingival Index, Quigley and Hein Plaque Index
Brief summary
The objective of this twelve-week clinical research study is to assess the efficacy of two brushing regimens: 1) toothpaste with mouthwash containing sodium fluoride/zinc and manual toothbrush as compared to 2) regular fluoride toothpaste and manual toothbrush in the reduction of dental plaque and aid of gum problems.
Interventions
DRUGTest Regimen
toothpaste \& mouthwash
DRUGControl Regimen
toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed Informed Consent Form. * Male and female subjects aged 18-70 years, inclusive. * Availability for the twelve-week duration of the clinical research study. * Good general health based on the opinion of the study investigator * Minimum of 20 permanent natural teeth (excluding third molars). * Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. * Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification)
Exclusion criteria
* Presence of orthodontic appliances. * Presence of partial removable dentures. * Tumor(s) of the soft or hard tissues of the oral cavity. * Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study. * Five or more carious lesions requiring immediate restorative treatment. * Antibiotic use any time during the one-month period prior to entry into the study. -Participation in any other clinical study or test panel within the one month prior to entry into the study. * Dental prophylaxis during the past two weeks prior to baseline examinations. * History of allergies to oral care/personal care consumer products or their ingredients. -On any prescription medicines that might interfere with the study outcome. * An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours. * History of alcohol and/or drug abuse. * Self-reported pregnancy and/or lactating subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quigley and Hein Plaque Index | Baseline, 3 weeks, 6 week & 12 weeks | reductions in dental plaque |
| Loe and Silness Gingival Index | Baseline, 3 weeks, 6 week & 12 weeks | assessment of gum problems (gingival scores) |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORAugusto R Elias-Boneta, DMD, MSD
Clinica Dental Dr. Sitges Carretera de Cardona
Outcome results
None listed