Assessing two brushing methods for reducing dental plaque and gingivitis

Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Dental Plaque and Aid of Gum Problems

This study is testing whether using a special toothpaste with mouthwash can help people reduce dental plaque and gum problems better than regular toothpaste over three months.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Colgate Palmolive (industry)
• Locations: 1 site (Manresa)
• Trial ID: NCT06240481 on ClinicalTrials.gov

What this trial studies

This clinical research study aims to evaluate the effectiveness of two different brushing regimens over a twelve-week period. Participants will use either a toothpaste with mouthwash containing sodium fluoride and zinc or regular fluoride toothpaste, both in conjunction with a manual toothbrush. The study will measure the reduction of dental plaque and improvement in gum health using established indices. The goal is to determine which regimen is more effective in managing dental plaque and gingivitis.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18-70 with at least 20 natural teeth and initial signs of gingivitis and plaque.

Not a fit: Patients with orthodontic appliances, removable dentures, or advanced periodontal disease are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved oral health practices that significantly reduce dental plaque and gingivitis.

How similar studies have performed: Previous studies have shown varying success with different oral hygiene regimens, but this specific comparison is less commonly tested.

Eligibility criteria

Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the twelve-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Minimum of 20 permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification)

Exclusion Criteria:

* Presence of orthodontic appliances.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period 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.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients. -On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
* History of alcohol and/or drug abuse.
* Self-reported pregnancy and/or lactating subjects.

Where this trial is running

Manresa

• Clinica Dental Dr. Sitges — Manresa, Spain (RECRUITING)

Study contacts

• Principal investigator: Augusto R Elias-Boneta, DMD, MSD — Clinica Dental Dr. Sitges Carretera de Cardona
• Study coordinator: Augusto R Elias-Boneta, DMD, MSD

Conditions: Dental Plaque, Gingivitis, plaque, gingivitis, Loe and Silness Gingival Index, Quigley and Hein Plaque Index