Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems

NCT07842991 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CRO-2026-07-PGN-GAD-ITA-YPZ
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Qualified subjects will be enrolled and randomized to either one of the three study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months and six months of product use. All subjects will be followed for adverse events throughout the study.

Conditions

Plaque; Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (3)

• Lobene Modified Gingivitis Assessment

  Modified Gingivitis Index score from 0 to 4 will be assigned by the examining dentist to all tooth surfaces using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored

  Baseline, 3 month, 6 month

• Saxton Gingival Bleeding Assessment

  Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding, a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing

  Baseline, 3 month, 6 month

• Modified Quigley-Hein Plaque Index

  First using a red dye solution to disclose the plaque, a Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.

  Baseline, 3 month, 6 month

Study Arms (3)

Test 1 toothpaste

EXPERIMENTAL

Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time

Drug: 0.45% SnF HW with NaF (1450 F)

Positive Control

ACTIVE COMPARATOR

Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time

Drug: 67% Bicarbonate with NaF (1400 F)

Negative Control

ACTIVE COMPARATOR

Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time

Drug: Colgate Cavity Protection Toothpaste

Interventions

0.45% SnF HW with NaF (1450 F) DRUG

toothpaste

Test 1 toothpaste

67% Bicarbonate with NaF (1400 F) DRUG

toothpaste

Positive Control

Colgate Cavity Protection Toothpaste DRUG

Toothpaste with MFP/NaF (1450 F)

Negative Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, ages 18-70, inclusive.
• Availability for the six-month duration of the study.
• Good general health.
• Initial gingivitis index of at least 1.5 as determined by the use of the Modified Gingivitis Index.
• Initial plaque index of at least 1.5 as determined by the use of the Modified Quigley-Hein Plaque Index.
• Signed Informed Consent Form

You may not qualify if:

• Orthodontic bands.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• Advanced periodontal disease (purulent exudate, tooth mobility), and/or
• Extensive loss of periodontal attachment or alveolar bone.
• Five or more carious lesions requiring immediate restorative treatment
• Use of antibiotics any time during the one month prior to entry into the study.
• Participation in any other clinical study or test panel within the one month prior to entry into the study.
• Received a dental prophylaxis in the two weeks prior to your initial examination.
• History of allergies to oral care/personal care consumer products or their ingredients.
• Having taken any prescription medicines that might interfere with the study outcome.
• If you with an existing medical condition which prohibits you from not eating or drinking for periods of up to 4 hours.
• Self-reported pregnant or breast feeding an infant.
• History of drug abuse

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Clinica Odontoiatrica Montesani

Roma, Rome, 00187, Italy

RECRUITING

MeSH Terms

Conditions

Plaque, Amyloid; Dental Plaque; Gingivitis

Interventions

Bicarbonates

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Anions; Ions; Electrolytes

Study Officials

• Luigi Montensani, DDS

  Clinica Odontoiatrica Montesani

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Montensani, DDS

CONTACT

+39-338-6187383;; luigi@montensani.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomized
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)