To Investigate the Clinical Efficacy of an Experimental Toothpaste

July 12, 2018 updated by: GlaxoSmithKline

Clinical Efficacy of an Experimental Toothpaste

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental toothpaste
0.1% isopropylmethylphenol and 1150ppm fluoride
Drug: isopropylmethylphenol and Fluoride
0.1% isopropylmethylphenol and 1150ppm fluoride
Other: Marketed toothpaste
NaF/Silica toothpaste containing 1150ppm fluoride
Drug: Fluoride and Silica
NaF/Silica toothpaste containing 1150ppm fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Modified Gingival Index at 24 weeks
Time Frame: baseline to 24 weeks
baseline to 24 weeks
Change from baseline Bleeding Index at 24 weeks
Time Frame: baseline to 24 weeks
baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Modified Gingival Index at weeks 6 & 12
Time Frame: baseline to week 12
baseline to week 12
Change from baseline Bleeding Index at weeks 6 & 12
Time Frame: baseline to week 12
baseline to week 12
Change from baseline Plaque Index at weeks 6, 12 & 24
Time Frame: baseline to week 24
baseline to week 24
Change from baseline plaque bacteria at weeks 12 & 24
Time Frame: baseline to week 24
baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 9, 2009

Primary Completion (Anticipated)

December 10, 2009

Study Completion (Anticipated)

December 10, 2009

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T3450803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingivitis

Clinical Trials on isopropylmethylphenol and Fluoride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe