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Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal

Primary Purpose

Dental Plaque

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Protegera™ toothpaste (NaF)
Crest™ Cavity Protection toothpaste (NaF)
Sponsored by
Protegera, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Salus Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
October 4, 2023
Last Updated
October 9, 2023
Sponsor
Protegera, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06082869
Brief Title
Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal
Official Title
Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protegera, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single-center, examiner-blinded, parallel design clinical trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Protegera™ toothpaste (NaF), brushing twice daily for one minute
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Crest™ Cavity Protection toothpaste (NaF), brushing twice daily for one minute
Intervention Type
Drug
Intervention Name(s)
Protegera™ toothpaste (NaF)
Intervention Description
Plaque Reduction
Intervention Type
Drug
Intervention Name(s)
Crest™ Cavity Protection toothpaste (NaF)
Intervention Description
Plaque Reduction
Primary Outcome Measure Information:
Title
Change In Dental Plaque
Description
Plaque measured on a scale of 0 to 5; 0 = No plaque; 5 = 2/3rd or more of tooth covered with plaque
Time Frame
Day 1 and Day 7 of manual brushing
Title
Changes in oral soft or hard tissues
Description
Examination of the oral cavity to determine any changes in color, soft tissue abrasion, texture or other irregularities
Time Frame
Day 1 and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery L Milleman, DDS, MPA
Organizational Affiliation
Salus Research, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus Research, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6980082
Citation
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.
Results Reference
result
PubMed Identifier
5264376
Citation
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.
Results Reference
result
PubMed Identifier
14489483
Citation
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.
Results Reference
result

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Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal

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