NCT02709785

Brief Summary

The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste perception, malodor and calculus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 4, 2018

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

March 9, 2016

Results QC Date

June 26, 2018

Last Update Submit

November 14, 2018

Conditions

GingivitisPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • Gingival Index

    Gingival Index scores gingival inflammation from 0 (healthy) to 3 (severe inflammation). The higher the score, the greater the gingival inflammation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.

    6 weeks

Secondary Outcomes (4)

  • Calculus Index

    6 weeks

  • Tooth Stain Index

    6 weeks

  • Plaque Index

    6 weeks

  • Bleeding Score

    6 weeks

Study Arms (3)

Group 1 SmartMouth

EXPERIMENTAL

24 subjects with plaque and gingival inflammation

Drug: SmartMouth Clinical DDS mouthrinse

Group 2 Chlorhexidine

EXPERIMENTAL

28 subjects with plaque and gingival inflammation

Drug: 0.12% chlorhexidine rinse

Group 3 Placebo

PLACEBO COMPARATOR

28 subjects with plaque and gingival inflammation

Drug: Placebo rinse

Interventions

SmartMouth Clinical DDS mouthrinseDRUG

Subjects use SmartMouth Clinical DDS mouth rinse for six weeks.

Group 1 SmartMouth
0.12% chlorhexidine rinseDRUG

Subjects use chlorhexidine mouth rinse for six weeks.

Group 2 Chlorhexidine
Placebo rinseDRUG

Subjects use placebo mouth rinse for six weeks. The placebo rinse is the same as SmartMouth Clinical DDS, but without the active ingredients.

Group 3 Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects between the ages of 18 to 80
  • Subjects with a diagnosis of gingivitis or chronic periodontitis
  • Entry levels of gingival inflammation and plaque accumulation will be present (mean Gingival Index ≥ 0.4 and Plaque Index ≥ 1.0)
  • Subjects that are in good medical health at time of the study
  • At least 20 permanent natural teeth

You may not qualify if:

  • Use of local or systemic antibiotics during the course of the study
  • Subjects that are pregnant or nursing mothers
  • Subjects undergoing orthodontic therapy
  • Subjects wearing removable prostheses
  • Subjects taking medication which is altering the gingiva or causing inflammation
  • Gingival overgrowth
  • History of sensitivity or suspected allergies following the use of oral hygiene products
  • Subjects taking anti-inflammatory or anticoagulant medications that would alter the gingiva and promote bleeding
  • Subjects that require antibiotic prophylaxis prior to dental treatment
  • Subjects that have acute dental problems requiring immediate treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Southern Illinois University School of Dental Medicine

Alton, Illinois, 62002, United States

Location

Saint Louis University Center for Advanced Dental Education

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

GingivitisPeriodontitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Results Point of Contact

Title
D. Douglas Miley
Organization
Saint Louis University
ddouglas.miley@health.slu.edu
314-977-8381

Study Officials

  • David D Miley, DMD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 16, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

December 4, 2018

Results First Posted

December 4, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)