Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal

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.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Drug: Protegera™ toothpaste (NaF); Drug: Crest™ Cavity Protection toothpaste (NaF)

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Have been males and females aged 18 to 69, in good general health.
2. Have read and signed an Informed Consent Form.
3. Have been in good health based on medical history review by the Principal Investigator.
4. 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.
5. (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).
6. 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.
7. 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.
8. 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.
9. 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.
10. Have agreed to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Had any known allergies or sensitivities to marketed dentifrice or oral hygiene products.
2. Had any physical limitations or restrictions which might preclude normal tooth brushing.
3. 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.
4. Self-reported as pregnant or nursing female.
5. Required antibiotic therapy within 30-days prior to study treatment.
6. Had a history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
7. 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.
8. Had severe periodontal disease or being actively treated for periodontal disease.
9. Had fixed or removable orthodontic appliances, bridges, peri/oral piercings, or removable partial dentures.
10. Had significant oral soft tissue pathology based on a visual examination baseline.
11. Had evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
12. Had received a dental prophylaxis within 30-days prior to Visit 1.
13. Had participated in another dental research study within 30-days prior to Visit 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Protegera™ toothpaste (NaF), brushing twice daily for one minute	Drug: Protegera™ toothpaste (NaF); Plaque Reduction
Active Comparator: Control; Crest™ Cavity Protection toothpaste (NaF), brushing twice daily for one minute	Drug: Crest™ Cavity Protection toothpaste (NaF); Plaque Reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 1 and Day 7

Collaborators and Investigators

• Sponsor: Protegera, Inc.
• Investigators: Principal Investigator: Jeffery L Milleman, DDS, MPA, Salus Research, Inc

Publications and helpful links

General Publications

• QUIGLEY 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.
• Turesky 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: Protegera-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No