Last updated: 11/04/2018 12:46:53

To investigate the clinical efficacy of an experimental toothpaste

GSK study ID
T3450803
Clinicaltrials.gov ID
NCT01079910
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical efficacy of an experimental toothpaste
Trial description: The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline Modified Gingival Index at 24 weeks

Timeframe: baseline to 24 weeks

Change from baseline Bleeding Index at 24 weeks

Timeframe: baseline to 24 weeks

Secondary outcomes:

Change from baseline Modified Gingival Index at weeks 6 & 12

Timeframe: baseline to week 12

Change from baseline Bleeding Index at weeks 6 & 12

Timeframe: baseline to week 12

Change from baseline Plaque Index at weeks 6, 12 & 24

Timeframe: baseline to week 24

Change from baseline plaque bacteria at weeks 12 & 24

Timeframe: baseline to week 24

Interventions:
Drug: isopropylmethylphenol and Fluoride
Drug: Fluoride and Silica
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2009-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gingivitis
Product
sodium fluoride
Collaborators
Not applicable
Study date(s)
December 2009 to December 2009
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
  • Inclusion Criteria:
  • Healthy subjects aged 18 years and older
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion Criteria:
  • Healthy subjects aged 18 years and older
  • A minimum of 20 permanent gradable teeth
  • For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.

Trial location(s)

Location
Status
Contact us
Contact us
Location
University Park Research Center (UPRC)
Fort Wayne, IN, United States, 46825
Status
Terminated/Withdrawn
Contact us

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Withdrawn
Actual primary completion date
2009-31-12
Actual study completion date
2009-31-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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