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Effect of Toothpaste on the Reduction of Plaque and Inflammation

Primary Purpose

Gingivitis, Dental Plaque

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Amine fluoride

Placebo

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring clinical trial, phase III, plaque index, gingivitis index, fluoride, toothpaste

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Technische Universität Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Control group

Arm Description

Amine fluoride toothpaste

Placebo Sodium monofluorophosphate toothpaste

Outcomes

Primary Outcome Measures

Plaque index (Silness and Loe 1964)

Difference of plaque index, compared between test group and control group.

Secondary Outcome Measures

Plaque index (Silness and Loe 1964)

Difference of plaque index, compared between test group and control group.

Plaque index (Silness and Loe 1964)

Difference of plaque index, compared between test group and control group.

Gingival Index (Loe 1967)

Difference of gingival index, compared between test group and control group.

Gingival Index (Loe 1967)

Difference of gingival index, compared between test group and control group.

Gingival Index (Loe 1967)

Difference of gingival index, compared between test group and control group.

Modified Sulcus Bleeding Index (Muhlemann and Son 1971):

Difference of bleeding index, compared between test group and control group.

Modified Sulcus Bleeding Index (Muhlemann and Son 1971):

Difference of bleeding index, compared between test group and control group.

Modified Sulcus Bleeding Index (Muhlemann and Son 1971):

Difference of bleeding index, compared between test group and control group.

Adverse events

List all

Full Information

NCT ID

NCT02552589

First Posted

September 3, 2015

Last Updated

February 5, 2016

Sponsor

Technische Universität Dresden

Collaborators

Colgate Palmolive

1. Study Identification

Unique Protocol Identification Number

NCT02552589

Brief Title

Effect of Toothpaste on the Reduction of Plaque and Inflammation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Technische Universität Dresden

Collaborators

Colgate Palmolive

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis, Dental Plaque

Keywords

clinical trial, phase III, plaque index, gingivitis index, fluoride, toothpaste

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

Amine fluoride toothpaste

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Placebo Sodium monofluorophosphate toothpaste

Intervention Type

Other

Intervention Name(s)

Amine fluoride

Intervention Description

toothpaste

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sodium monofluorophosphate

Intervention Description

toothpaste

Primary Outcome Measure Information:

Title

Plaque index (Silness and Loe 1964)

Description

Difference of plaque index, compared between test group and control group.

Time Frame

Change in plaque index from baseline at 12 weeks

Secondary Outcome Measure Information:

Title

Plaque index (Silness and Loe 1964)

Description

Difference of plaque index, compared between test group and control group.

Time Frame

Change in plaque index from baseline at 3 weeks

Title

Plaque index (Silness and Loe 1964)

Description

Difference of plaque index, compared between test group and control group.

Time Frame

Change in plaque index from week 3 at 12 weeks

Title

Gingival Index (Loe 1967)

Description

Difference of gingival index, compared between test group and control group.

Time Frame

Change in gingival index from baseline at 3 weeks

Title

Gingival Index (Loe 1967)

Description

Difference of gingival index, compared between test group and control group.

Time Frame

Change in gingival index from baseline at 12 weeks

Title

Gingival Index (Loe 1967)

Description

Difference of gingival index, compared between test group and control group.

Time Frame

Change in gingival index from 3 weeks at week 12

Title

Modified Sulcus Bleeding Index (Muhlemann and Son 1971):

Description

Difference of bleeding index, compared between test group and control group.

Time Frame

Change in bleeding index from baseline at 12 weeks

Title

Modified Sulcus Bleeding Index (Muhlemann and Son 1971):

Description

Difference of bleeding index, compared between test group and control group.

Time Frame

Change in bleeding index from baseline at week 3

Title

Modified Sulcus Bleeding Index (Muhlemann and Son 1971):

Description

Difference of bleeding index, compared between test group and control group.

Time Frame

Change in bleeding index from week 3 at week 12

Title

Adverse events

Description

List all

Time Frame

up to 12 weeks from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Technische Universität Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

12. IPD Sharing Statement

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Effect of Toothpaste on the Reduction of Plaque and Inflammation

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