Investigation of Dental Plaque and Gingival Index

Dental Plaque Clinical Trial

Official title:

Investigation of Dental Plaque and Gingival Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759031
• Other study ID #: CRO-2007-PLA-23-RR
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: April 11, 2012
• Start date: February 2008
• Est. completion date: March 2008

Study information

• Verified date: April 2012
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

• Must discontinue oral hygiene for 24-hrs.after initial appointment.

• 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 drugs that can currently affect salivary flow

• 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 clinical study in the month preceding this study

• Allergic to common dentifrice ingredients.

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Sodium Monofluorophosphate
Brush teeth and evaluate plaque score after one use of the study toothpaste
• Triclosan/Fluoride/Copolymer
Brush teeth and evaluate plaque score after one use of the study toothpaste

Locations

Country	Name	City	State
United States	Boston University School of Dental Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival Margin Plaque Index	Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.	1 day	No