GingivitisNCT02552589
Effect of Toothpaste on the Reduction of Plaque and Inflammation
A study testing Amine fluoride in people with Gingivitis and Dental Plaque, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Amine fluoride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Amine fluoride, Placebo
- Keywords
- clinical trial, phase III, plaque index, gingivitis index, fluoride, toothpaste
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amine fluorideOther
toothpaste
PlaceboOther
Also called Sodium monofluorophosphate
toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Amine fluoride toothpaste Receives: Other: Amine fluoride |
| Control group | Placebo comparator | Placebo Sodium monofluorophosphate toothpaste Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index (Silness and Loe 1964)
Difference of plaque index, compared between test group and control group.
Measured: Change in plaque index from baseline at 12 weeks
Secondary outcomes (9)
Plaque index (Silness and Loe 1964)
Difference of plaque index, compared between test group and control group.
Measured: Change in plaque index from baseline at 3 weeks
Plaque index (Silness and Loe 1964)
Difference of plaque index, compared between test group and control group.
Measured: Change in plaque index from week 3 at 12 weeks
Gingival Index (Loe 1967)
Difference of gingival index, compared between test group and control group.
Measured: Change in gingival index from baseline at 3 weeks
Gingival Index (Loe 1967)
Difference of gingival index, compared between test group and control group.
Measured: Change in gingival index from baseline at 12 weeks
Gingival Index (Loe 1967)
Difference of gingival index, compared between test group and control group.
Measured: Change in gingival index from 3 weeks at week 12
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Difference of bleeding index, compared between test group and control group.
Measured: Change in bleeding index from baseline at 12 weeks
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Difference of bleeding index, compared between test group and control group.
Measured: Change in bleeding index from baseline at week 3
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Difference of bleeding index, compared between test group and control group.
Measured: Change in bleeding index from week 3 at week 12
Adverse events
List all
Measured: up to 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Principal investigator, Katrin Lorenz, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552589
- Sponsor's protocol ID
- PAR012015
- Status last verified
- Feb 2016
- First submitted
- 3 Sep 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of an Experimental Toothpaste on the Reduction of Dental Plaque and Gingival Inflammation
- ClinicalTrials.gov ID
- NCT02552589
- Acronym / sponsor ID
- PAR012015
- Conditions
- Gingivitis, Dental Plaque
- Keywords
- clinical trial, phase III, plaque index, gingivitis index, fluoride, toothpaste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Amine fluorideAmine fluoride toothpaste |
| Control group | Placebo comparator | Other: PlaceboPlacebo Sodium monofluorophosphate toothpaste |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amine fluoridetoothpaste | Other | Test group |
| PlaceboAlso: Sodium monofluorophosphatetoothpaste | Other | Control group |
Primary outcome
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.
9 secondary outcomes
Plaque index (Silness and Loe 1964)
Time frame: 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
Gingival Index (Loe 1967)
Time frame: Change in gingival index from baseline at 3 weeks
Gingival Index (Loe 1967)
Time frame: 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
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Time frame: 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
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Time frame: Change in bleeding index from week 3 at week 12
Adverse events
Time frame: up to 12 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amine fluoride in people with Gingivitis and Dental Plaque, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (Silness and Loe 1964) (time frame: Change in plaque index from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.