Clinical Research Study Efficacy of a Prototype Oral Rinse

NCT01021007 | Completed Phase 3 Results

• 1 other identifier: CRO-1007-GIN-02-RR
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (3)

• Gingival Index

  1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding

  6 weeks

• EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale

  0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 \& 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.

  6 weeks

• Plaque Index (Quigley-Hein Score)

  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)

  6 weeks

Study Arms (2)

A

PLACEBO COMPARATOR

control mouthrinse

Other: water

B

EXPERIMENTAL

new prototype mouthrinse

Drug: Iodine

Interventions

Iodine DRUG

Rinse 2 times per day for 6 weeks

Also known as: Iocide (proprietary company name)

B

water OTHER

Use 2 times per day for 6 weeks

Also known as: No actives present in control mouthrinse. (Flavored water)

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female volunteers 18-65 years of age
• Good general health
• Must sign informed consent form
• Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
• No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
• Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

You may not qualify if:

• Subjects unable or unwilling to sign the informed consent form.
• Medical condition which requires pre-medication prior to dental visits/procedures
• Moderate or advanced periodontal disease
• History of allergy to iodine
• History of thyroid disease
• History of diabetes
• or more decayed untreated dental sites at screening.
• Other disease of the hard or soft oral tissues.
• Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
• Use of medications that are currently affect salivary flow.
• Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
• Pregnant or nursing women.
• Participation in any other clinical study within 1 week prior to enrollment into this study.
• Use of tobacco products
• Subjects who must receive dental treatment during the study dates.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

New Institutional Service Company

Northfield, New Jersey, 08225, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Iodine; Water

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Halogens; Elements; Inorganic Chemicals; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: William DeVizio - DMD
• Organization: Colgate Palmolive

william_devizio@colpal.com

732-878-7901

Study Officials

• Matthew Cronin, DMD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: November 26, 2009
• Study Start: October 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: December 1, 2009
• Results First Posted: November 26, 2009

Record last verified: 2009-10

Locations

US (1)