Dental PlaqueEarly Phase 1NCT06082869
Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal
A Early Phase 1 study testing Protegera™ toothpaste (NaF) and Crest™ Cavity Protection toothpaste (NaF) in people with Dental Plaque, run by Protegera, Inc. at 1 site in United States.
Trial summary
To evaluate and compare plaque removal efficacy and safety of a novel dentifrice formulation immediately after the first supervised use and following one week of twice, daily use at home. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Protegera™ toothpaste (NaF) and Crest™ Cavity Protection toothpaste (NaF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 23 Feb 2023
- Phase
- Early Phase 1
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have been males and females aged 18 to 69, in good general health.
- Have read and signed an Informed Consent Form.
- Have been in good health based on medical history review by the Principal Investigator.
- Have had a minimum of 18 natural teeth with scorable facial and lingual surfaces. Teeth that were grossly carious, orthodontically banded, restorations such as crowns, veneers or implants, exhibit general cervical abrasion and/or enamel abrasion, or third molars were not included in the tooth count.
- (If female of child bearing age) have been using an established method of birth control (systemic contraceptives such as birth control pills, injectable contraceptive or patch contraceptives, partner with vasectomy, condom with additional spermicide, IUD or abstinence).
- Have had a mean full-mouth pre-brushing plaque score (Soparkar Modification1 of the Turesky Modification2 of the plaque index of Quigley and Hein.3) of ≥ 2.00 at the baseline visit.
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- Have agreed not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the 7-day study.
- Have been willing to refrain from all oral hygiene procedures (including chewing gum) for 24 hrs. and refrained from eating, drinking and smoking for approximately 2 hours prior to Visits 1 \& 2.
- Have agreed to refrain from use of all oral hygiene products (i.e., floss, mouthwash, etc.), other than the toothbrush and toothpaste supplied, for the duration of the 7-day study.
- Have agreed to comply with the conditions and schedule of the study.
Who cannot join
- Had any known allergies or sensitivities to marketed dentifrice or oral hygiene products.
- Had any physical limitations or restrictions which might preclude normal tooth brushing.
- Had existing serious medical condition or transmittable disease as determined after review of the medical history form. These will include but not be limited to: active hepatitis, tuberculosis, AIDS, asthma, bleeding disorder, diabetes, cirrhosis, leukemia, renal disease, sarcoidosis, vascular disease, thrush, or leukoplakia.
- Self-reported as pregnant or nursing female.
- Required antibiotic therapy within 30-days prior to study treatment.
- Had a history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
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- Had received therapy with any medications, currently or within the last 30 days, which might interfere with the outcome of the study by affecting tissue condition, or salivation, particularly chronic therapy or long-term use, as determined by the investigator.
- Had severe periodontal disease or being actively treated for periodontal disease.
- Had fixed or removable orthodontic appliances, bridges, peri/oral piercings, or removable partial dentures.
- Had significant oral soft tissue pathology based on a visual examination baseline.
- Had evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
- Had received a dental prophylaxis within 30-days prior to Visit 1.
- Had participated in another dental research study within 30-days prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate and compare plaque removal efficacy and safety of a novel dentifrice formulation immediately after the first supervised use and following one week of twice, daily use at home.
Read the detailed description
Study participants brushed their teeth for one minute, two times daily, for seven days.
Participants who met study entry criteria were randomized to either the test (Protegera™) or control (Crest™ Cavity Protection) toothpaste, and each were given the same straight, soft bristled toothbrush to use throughout the study.
On Day 1, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
On Day 7, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
- Conditions
- Dental Plaque
- Being tested
- Protegera™ toothpaste (NaF), Crest™ Cavity Protection toothpaste (NaF)
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protegera™ toothpaste (NaF)Drug
Plaque Reduction
Crest™ Cavity Protection toothpaste (NaF)Drug
Plaque Reduction
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Protegera™ toothpaste (NaF), brushing twice daily for one minute Receives: Drug: Protegera™ toothpaste (NaF) |
| Control | Active comparator | Crest™ Cavity Protection toothpaste (NaF), brushing twice daily for one minute Receives: Drug: Crest™ Cavity Protection toothpaste (NaF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Dental Plaque
Plaque measured on a scale of 0 to 5; 0 = No plaque; 5 = 2/3rd or more of tooth covered with plaque
Measured: Day 1 and Day 7 of manual brushing
Changes in oral soft or hard tissues
Examination of the oral cavity to determine any changes in color, soft tissue abrasion, texture or other irregularities
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start30 Jan 2023
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-center, examiner-blinded, parallel design clinical trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protegera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery L Milleman, DDS, MPA, Principal investigator, Salus Research, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082869
- Sponsor's protocol ID
- Protegera-2023-01
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lobene RR, Soparkar PM, Newman MB. Use of dental floss. Effect on plaque and gingivitis. Clin Prev Dent. 1982 Jan-Feb;4(1):5-8. No abstract available.
PubMed 6980082Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
PubMed 5264376QUIGLEY GA, HEIN JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc. 1962 Jul;65:26-9. doi: 10.14219/jada.archive.1962.0184. No abstract available.
PubMed 14489483
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal
- ClinicalTrials.gov ID
- NCT06082869
- Acronym / sponsor ID
- Protegera-2023-01
- Conditions
- Dental Plaque
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Protegera, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 13 Oct 2023 (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.
To evaluate and compare plaque removal efficacy and safety of a novel dentifrice formulation immediately after the first supervised use and following one week of twice, daily use at home.
Detailed description
Study participants brushed their teeth for one minute, two times daily, for seven days.
Participants who met study entry criteria were randomized to either the test (Protegera™) or control (Crest™ Cavity Protection) toothpaste, and each were given the same straight, soft bristled toothbrush to use throughout the study.
On Day 1, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
On Day 7, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-center, examiner-blinded, parallel design clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Protegera™ toothpaste (NaF)Protegera™ toothpaste (NaF), brushing twice daily for one minute |
| Control | Active comparator | Drug: Crest™ Cavity Protection toothpaste (NaF)Crest™ Cavity Protection toothpaste (NaF), brushing twice daily for one minute |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have been males and females aged 18 to 69, in good general health.
- Have read and signed an Informed Consent Form.
- Have been in good health based on medical history review by the Principal Investigator.
- Have had a minimum of 18 natural teeth with scorable facial and lingual surfaces. Teeth that were grossly carious, orthodontically banded, restorations such as crowns, veneers or implants, exhibit general cervical abrasion and/or enamel abrasion, or third molars were not included in the tooth count.
- (If female of child bearing age) have been using an established method of birth control (systemic contraceptives such as birth control pills, injectable contraceptive or patch contraceptives, partner with vasectomy, condom with additional spermicide, IUD or abstinence).
Key exclusion criteria (13 listed)
- Had any known allergies or sensitivities to marketed dentifrice or oral hygiene products.
- Had any physical limitations or restrictions which might preclude normal tooth brushing.
- Had existing serious medical condition or transmittable disease as determined after review of the medical history form. These will include but not be limited to: active hepatitis, tuberculosis, AIDS, asthma, bleeding disorder, diabetes, cirrhosis, leukemia, renal disease, sarcoidosis, vascular disease, thrush, or leukoplakia.
- Self-reported as pregnant or nursing female.
- Required antibiotic therapy within 30-days prior to study treatment.
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 |
|---|---|---|
| Protegera™ toothpaste (NaF)Plaque Reduction | Drug | Experimental |
| Crest™ Cavity Protection toothpaste (NaF)Plaque Reduction | Drug | Control |
Primary outcome
Change In Dental Plaque
Time frame: Day 1 and Day 7 of manual brushing
Plaque measured on a scale of 0 to 5; 0 = No plaque; 5 = 2/3rd or more of tooth covered with plaque
Changes in oral soft or hard tissues
Time frame: Day 1 and Day 7
Examination of the oral cavity to determine any changes in color, soft tissue abrasion, texture or other irregularities
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 13 Oct 2023.
- Results publication: PubMed 6980082Lobene RR, Soparkar PM, Newman MB. Use of dental floss. Effect on plaque and gingivitis. Clin Prev Dent. 1982 Jan-Feb;4(1):5-8. No abstract available.
- Results publication: PubMed 5264376Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
- Results publication: PubMed 14489483QUIGLEY GA, HEIN JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc. 1962 Jul;65:26-9. doi: 10.14219/jada.archive.1962.0184. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Dental Plaque
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Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
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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.
Jeffery L Milleman, DDS, MPA principal investigator
Salus Research, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Protegera™ toothpaste (NaF) and Crest™ Cavity Protection toothpaste (NaF) in people with Dental Plaque, run by Protegera, Inc. at 1 site in United States.
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 10 inclusion and 13 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 13 Oct 2023. 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 United States. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change In Dental Plaque (time frame: Day 1 and Day 7 of manual brushing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06082869, which also lists 3 linked publications.
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 13 Oct 2023.