Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal

NCT06082869 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Protegera-2023-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

Protegera™ toothpaste (NaF), brushing twice daily for one minute

Drug: Protegera™ toothpaste (NaF)

Control

ACTIVE COMPARATOR

Crest™ Cavity Protection toothpaste (NaF), brushing twice daily for one minute

Drug: Crest™ Cavity Protection toothpaste (NaF)

Interventions

Protegera™ toothpaste (NaF) DRUG

Plaque Reduction

Experimental

Crest™ Cavity Protection toothpaste (NaF) DRUG

Plaque Reduction

Control

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Protegera, Inc.: lead

Study Sites (1)

Salus Research, Inc

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (3)

• 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.

  PMID: 6980082 RESULT

• 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.

  PMID: 5264376 RESULT

• 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.

  PMID: 14489483 RESULT

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jeffery L Milleman, DDS, MPA

  Salus Research, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators performing plaque scoring, study coordinators entering plaque scores and handling data, and the statistician performing the data analysis were all blinded to the treatment regimen
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single-center, examiner-blinded, parallel design clinical trial.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 13, 2023
• Study Start: January 30, 2023
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)