Effect of Toothpaste on the Reduction of Plaque and Inflammation

February 5, 2016 updated by: Katrin Lorenz, Technische Universität Dresden

Clinical Evaluation of the Effect of an Experimental Toothpaste on the Reduction of Dental Plaque and Gingival Inflammation

The purpose of this double blind study is to prove whether a fluoride containing toothpaste is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before study start, investigators and study nurses will be trained on how to apply SOPs, parameters, and adverse event management. On-site monitoring will be done by the sponsor after recruitment, after visit 2 and after the final visit.

All source data will be entered in paper CRFs. For the statistical analysis these data will be entered into the data bank via double data entry. Programmed range checks, validity checks, consistency checks, and manual/visual data checks for medicinal plausibility will be done before the blind data review meeting. During blind data review meeting minor protocol violations will be recorded and assessed. No imputation of missing data will be done for ITT or PP analyses.

The sample size estimation was carried out by means of one-sided unpaired t-test with a one-sided significance level of α=0.05. For testing superiority of the test product over negative control, the investigators test the hypothesis, H0: μTest product - μNegative control ≤ 0 H1: μTest product - μNegative control > 0 by using a one-sided t-test with α=0.05. A relevant difference of Δ=0.14 and a standard deviation of σ=0.4 was assumed based on previous studies. When estimating a drop-out rate of about 20 % a total of 120 = 102 + 18 subjects per group will be assigned at study start. Drop-outs will not be replaced during the study.

The primary parameter is the difference of plaque index between baseline (V1) value and the value after 12 weeks +/- 5 days (V3) of product use. For primary statistical analysis, a t-tests (unpaired situation) will be performed at a one-sided significance level of α=0.05. The primary efficacy analysis will be performed on the ITT-analysis set.

Secondary variables will be assessed with t-tests and confidence intervals to compare differences between V2, V3, and baseline for test product group and negative control group. Descriptive statistics will be performed for oral examinations for each group (counts and percentages of scores for nominal and ordinal scaled data, for at least ordinal scaled data minimum, maximum, median, mean value and standard deviation).

A two-sided significance level of α=0.05 is chosen for all secondary analyses, no adjustment for multiplicity will be done. Safety assessments will be based mainly on the frequency of adverse events.

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Technische Universität Dresden

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female adults (aged 18 to 65 years),
  • Individuals with gingival inflammation, mean full-mouth GI ≥ 1.2 at inclusion,
  • Individuals with plaque, mean full-mouth PI ≥ 1.2 at inclusion,
  • Non-smokers or former smokers for at least 1 year or occasional smokers with a maximum of 5 cigarettes per week,
  • Individuals who have at least 20 own teeth excluding the wisdom teeth,
  • Subjects must have read, understood and signed the informed consent form
  • Willingness to abstain from use of interdental brushing devices that contain antibacterial agents, like amine fluoride, chlorhexidine, silver ions etc. during the full course of the study

Exclusion Criteria:

  • Individuals who have severe systemic diseases (tumors, infectious diseases) and diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics)
  • Individuals who have moderate and severe chronic or aggressive periodontitis (PSI > 2 in more than 2 sextants or PSI > 3),
  • Individuals who require antibiotic treatments for dental appointments (endocarditis prophylaxis), Individuals treated with antibiotics less than 8 weeks prior to the baseline examination and/or during the duration of the trial,
  • Individuals who have participated in another clinical study less than 4 weeks prior to the baseline examination,
  • Individuals who have mucosal diseases,
  • Individuals who have severe oro-pharyngeal infections,
  • Individuals who have significant dental disorders (e.g.: caries, suspected pulp pathology, abscess, pulpitis),
  • History of gingival surgery in the previous three month,
  • Ongoing dental treatment or any other medical treatment of the oral cavity,
  • Individuals who are pregnant or breast feeding,
  • Individuals with a history of chronic drug abuse or another illness which does not allow the person to assess the nature and/or possible consequences of the study,
  • Smokers with more than 5 cigarettes per week,
  • Individuals with known hypersensitivity or allergy to the test products and its ingredients,
  • Individuals who were treated with antibacterial mouthrinses (e. g. chlorhexidine) 4 weeks or less before recruitment,
  • Individuals unwilling to abstain from additional oral hygiene measures during the treatment phase with exception of their habitual mechanical cleaning procedures,
  • Non-Caucasians,
  • Subjects can be excluded at the principal investigators discretion.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
Amine fluoride toothpaste
Other: Amine fluoride
toothpaste
Placebo Comparator: Control group
Placebo Sodium monofluorophosphate toothpaste
Other: Placebo
toothpaste
Other Names:
  • Sodium monofluorophosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index (Silness and Loe 1964)
Time Frame: Change in plaque index from baseline at 12 weeks
Difference of plaque index, compared between test group and control group.
Change in plaque index from baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index (Silness and Loe 1964)
Time Frame: Change in plaque index from baseline at 3 weeks
Difference of plaque index, compared between test group and control group.
Change in plaque index from baseline at 3 weeks
Plaque index (Silness and Loe 1964)
Time Frame: Change in plaque index from week 3 at 12 weeks
Difference of plaque index, compared between test group and control group.
Change in plaque index from week 3 at 12 weeks
Gingival Index (Loe 1967)
Time Frame: Change in gingival index from baseline at 3 weeks
Difference of gingival index, compared between test group and control group.
Change in gingival index from baseline at 3 weeks
Gingival Index (Loe 1967)
Time Frame: Change in gingival index from baseline at 12 weeks
Difference of gingival index, compared between test group and control group.
Change in gingival index from baseline at 12 weeks
Gingival Index (Loe 1967)
Time Frame: Change in gingival index from 3 weeks at week 12
Difference of gingival index, compared between test group and control group.
Change in gingival index from 3 weeks at week 12
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Time Frame: Change in bleeding index from baseline at 12 weeks
Difference of bleeding index, compared between test group and control group.
Change in bleeding index from baseline at 12 weeks
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Time Frame: Change in bleeding index from baseline at week 3
Difference of bleeding index, compared between test group and control group.
Change in bleeding index from baseline at week 3
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Time Frame: Change in bleeding index from week 3 at week 12
Difference of bleeding index, compared between test group and control group.
Change in bleeding index from week 3 at week 12
Adverse events
Time Frame: up to 12 weeks from baseline
List all
up to 12 weeks from baseline

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Collaborators

Colgate Palmolive

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

September 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAR012015

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 Amine fluoride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe