NCT00855933

Brief Summary

This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in healthy adults with mild-to-moderate gingivitis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

February 8, 2013

Completed
Last Updated

February 8, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

March 3, 2009

Results QC Date

December 3, 2012

Last Update Submit

January 7, 2013

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale

    A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth \& sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation). For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.

    4 weeks

Study Arms (2)

Control - no flossing

NO INTERVENTION

Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily.

Experimental Floss

EXPERIMENTAL

Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily. Subjects flossed once daily with the experimental floss.

Device: Experimental Floss

Interventions

Experimental FlossDEVICE

Experimental Glide® floss with cetylpyridinium chloride (\~13% dry weight CPC)

Also known as: Glide®, floss, cetylpyridinium chloride, CPC
Experimental Floss

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age;
  • physically able to floss his/her teeth;
  • refrained from performing oral hygiene the morning of the Baseline visit;
  • have measurable gingivitis on at least 5 test sites;
  • in good general health.

You may not qualify if:

  • severe periodontal disease
  • atypical discoloration or pigmentation in the gingival tissue;
  • meaningful malocclusion of the anterior teeth;
  • fixed facial orthodontic appliances;
  • use of antibiotics within two weeks of the baseline visit and at any time during the study;
  • any diseases or conditions that could be expected to interfere with the subject safely completing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Geza Terézhalmy, DDS , MA

San Antonio, Texas, 78229, United States

Location

Luis R. Archila, DDS

Guatemala City, Guatemala

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Dental Devices, Home Care

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental EquipmentDentistryOral HygienePreventive DentistryEquipment and Supplies

Results Point of Contact

Title
Jon Witt
Organization
The Procter & Gamble Co.
witt.jj.2@pg.com
513-622-2963

Study Officials

  • Aaron Biesbrock, DMD, PhD

    Procter and Gamble

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 5, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 8, 2013

Results First Posted

February 8, 2013

Record last verified: 2013-01

Locations

GU(1)US(1)