Clinical Research Study to Assess the Efficacy of Two Brushing Regimens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dental Plaque Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group I

Meridol ToothPaste Brush 2 x day / 2 mins Meridol Mouthwash (AmCl+Zn +NaF) Swish 15 mL / 30 secs after brushing

Group Type ACTIVE_COMPARATOR

Test Regimen

Intervention Type DRUG

toothpaste \& mouthwash

Control Regimen

Intervention Type DRUG

toothpaste

Group II

regular fluoride ToothPaste, Brush 2 x day 2 mins

Group Type PLACEBO_COMPARATOR

Test Regimen

Intervention Type DRUG

toothpaste \& mouthwash

Control Regimen

Intervention Type DRUG

toothpaste

Interventions

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Test Regimen

toothpaste \& mouthwash

Intervention Type DRUG

Control Regimen

toothpaste

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes