Clinical Research Study to Assess the Efficacy of Two Brushing Regimens

NCT06240481 | Completed Phase 3

• 1 other identifier: CRO-2024-02-PG-MRG-SP-BGS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this twelve-week clinical research study is to assess the efficacy of two brushing regimens: 1) toothpaste with mouthwash containing sodium fluoride/zinc and manual toothbrush as compared to 2) regular fluoride toothpaste and manual toothbrush in the reduction of dental plaque and aid of gum problems.

Conditions

Dental Plaque; Gingivitis

Keywords

plaque; gingivitis; Loe and Silness Gingival Index; Quigley and Hein Plaque Index

Outcome Measures

Primary Outcomes (2)

• Quigley and Hein Plaque Index

  reductions in dental plaque

  Baseline, 3 weeks, 6 week & 12 weeks

• Loe and Silness Gingival Index

  assessment of gum problems (gingival scores)

  Baseline, 3 weeks, 6 week & 12 weeks

Study Arms (2)

Group I

ACTIVE COMPARATOR

Meridol regimen comprises an amine base compound, zinc lactate and NaF (AZF) toothpaste and mouthwash, brush 2x day/2min and swish 15ml/30 secs after brushing

Drug: Test Regimen; Drug: Control Regimen

Group II

PLACEBO COMPARATOR

Regular fluoride toothpaste, Brush 2 x day 2 mins

Drug: Test Regimen; Drug: Control Regimen

Interventions

Test Regimen DRUG

toothpaste \& mouthwash

Group I; Group II

Control Regimen DRUG

toothpaste

Group I; Group II

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• Presence of orthodontic appliances.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Clinica Dental Dr. Sitges

Manresa, 08241, Spain

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

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

Study Officials

• Augusto R Elias-Boneta, DMD, MSD

  Clinica Dental Dr. Sitges Carretera de Cardona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: September 23, 2024
• Primary Completion: December 21, 2024
• Study Completion: December 21, 2024
• Last Updated: February 6, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)