Plaque, DentalPhase 3NCT06366568
Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas
A Phase 3 study testing fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product and fluoride toothpaste containing 1450 ppm of MFP in a PCC base in people with Plaque, Dental, run by Colgate Palmolive at 1 site in Germany.
Trial summary
The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental
- What is being tested?
- fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product and fluoride toothpaste containing 1450 ppm of MFP in a PCC base
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- 19 Feb 2024to 6 Mar 2024
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- You must provide consent to participate by signing this informed consent form.
- Available for the two(2) week study duration.
- You must be at least eighteen(18) years old and not older than seventy(70) years of age.
- You must not smoke.
- You must be in good general health for participation in the study, based on the opinion of the study investigator.
- You must have at least 20 natural permanent teeth.
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- Your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner.
- You must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire.
- You must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
Who cannot join
- Medical condition which requires premedication prior to dental visits/procedures.
- Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations.
- Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months.
- Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care.
- Abnormalities/diseases of the soft or hard oral tissues.
- Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
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- Current smokers and/or tobacco users and/or a history of alcohol or drug abuse.
- Use of drugs that can affect salivary flow.
- Use of antibiotics one (1) month prior to study entry and/or during participation in this study.
- Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion.
- Self-reported pregnancy and/or breastfeeding.
- Current Participation in another clinical study or during the month prior to this clinical study entry.
- Known allergies and/or reactions to common dentifrice ingredients.
- Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits.
- Immunocompromised conditions (AIDS, immunosuppressive drug therapy).
- Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras
Dresden, 01307
About this study
Official title: Clinical Investigation to Assess the Efficacy of a Eugenol-based Product in Improving the Quality of Toothbrushing Measured by Plaque Assessment and Patient Perception Questionnaire and Relieving Gum Discomfort Areas
The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial.
- Conditions
- Plaque, Dental
- Being tested
- fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product, fluoride toothpaste containing 1450 ppm of MFP in a PCC base
- Keywords
- plaque gingivitis
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum productDrug
PARTICIPANTS WILL USE A EUGENOL BASED product PRIOR TO TOOTHBRUSHING
fluoride toothpaste containing 1450 ppm of MFP in a PCC baseDrug
toothbrushing 2x a day for 2 minutes each time
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | toothpaste and gum product, brushing 2x a day for 2 minutes followed by gum product application Receives: Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product |
| Group 2 | Placebo comparator | toothpaste , brushing 2x a day for 2 minutes Receives: Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turesky Modification of the Quigley & Hein Plaque Index
Reduction in plaque measurement is served as primary efficacy variable are served. The scoring scheme for the Turesky Modification of the Quigley-Hein dental plaque index is as follows: 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.
Measured: baseline and six months
Secondary outcomes (1)
questionnaire
self-reported questionnaires are served as secondary efficacy variable.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start19 Feb 2024
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, DentalStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366568
- Sponsor's protocol ID
- CRO-2022-10-PG-MER-MW-JG
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Assess the Efficacy of a Eugenol-based Product in Improving the Quality of Toothbrushing Measured by Plaque Assessment and Patient Perception Questionnaire and Relieving Gum Discomfort Areas
- ClinicalTrials.gov ID
- NCT06366568
- Acronym / sponsor ID
- CRO-2022-10-PG-MER-MW-JG
- Conditions
- Plaque, Dental
- Keywords
- plaque gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- 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 objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial.
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 |
|---|---|---|
| Group 1 | Experimental | Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum producttoothpaste and gum product, brushing 2x a day for 2 minutes followed by gum product application |
| Group 2 | Placebo comparator | Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC basetoothpaste , brushing 2x a day for 2 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- You must provide consent to participate by signing this informed consent form.
- Available for the two(2) week study duration.
- You must be at least eighteen(18) years old and not older than seventy(70) years of age.
- You must not smoke.
- You must be in good general health for participation in the study, based on the opinion of the study investigator.
Key exclusion criteria (16 listed)
- Medical condition which requires premedication prior to dental visits/procedures.
- Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations.
- Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months.
- Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care.
- Abnormalities/diseases of the soft or hard oral tissues.
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 |
|---|---|---|
| fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum productPARTICIPANTS WILL USE A EUGENOL BASED product PRIOR TO TOOTHBRUSHING | Drug | Group 1 |
| fluoride toothpaste containing 1450 ppm of MFP in a PCC basetoothbrushing 2x a day for 2 minutes each time | Drug | Group 2 |
Primary outcome
Turesky Modification of the Quigley & Hein Plaque Index
Time frame: baseline and six months
Reduction in plaque measurement is served as primary efficacy variable are served. The scoring scheme for the Turesky Modification of the Quigley-Hein dental plaque index is as follows: 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.
1 secondary outcome
questionnaire
Time frame: six months
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 16 Apr 2024.
- Individual participant dataSharing planned: No
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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 Phase 3 study testing fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product and fluoride toothpaste containing 1450 ppm of MFP in a PCC base in people with Plaque, Dental, run by Colgate Palmolive 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 9 inclusion and 16 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 16 Apr 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Turesky Modification of the Quigley & Hein Plaque Index (time frame: baseline and six months). 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 16 Apr 2024.