Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a pre-procedure to a professional dental cleaning.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.

NCT07149376

Sensitivity, Tooth

COMPLETED PHASE3

Oothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste in Reducing Dentinal Hypersensitivity

NCT07257042

Hypersensitivity

COMPLETED PHASE3

Dentinal Hypersensitivity Reduction Efficacy Study

NCT06960148

Sensitivity, Tooth

RECRUITING PHASE3

Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction

NCT01040169

Hypersensitivity

COMPLETED NA

Arginine Plaque Metabolism Pilot Clinical Study

NCT06954779

Plaque, Dental

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypersensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ProClude Prophylaxis paste-A

Arginine Bicarbonate prophylaxis paste

Group Type ACTIVE_COMPARATOR

Arginine/Calcium Carbonate

Intervention Type DEVICE

One time treatment

Nupro-M Prophylaxis paste -B

Control prophylaxis paste (Fluoride free - placebo)

Group Type PLACEBO_COMPARATOR

Nupro - Fluoride Free

Intervention Type DEVICE

Brush twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arginine/Calcium Carbonate

One time treatment

Intervention Type DEVICE

Nupro - Fluoride Free

Brush twice daily

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects, ages 18-70, inclusive.
* Availability for the three (3) week duration of the study.
* Two (2) sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
* Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50gms. of force.
* Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
* Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
* Good general health with no known allergies to products being tested.
* Use of a non-desensitizing dentifrice for three months prior to entry into the study.
* Signed Informed Consent Form.

Exclusion Criteria

* Gross oral pathology, chronic disease, or history of allergy to test products.
* Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
* Scheduled dental prophylaxis within three weeks prior to the Baseline Hypersensitivity Examination.
* Sensitive teeth with mobility greater than one.
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
* Subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study.
* Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
* Current participation in any other clinical study.
* Pregnant or lactating subjects.
* Allergies to oral care products, personal care consumer products, or their ingredients.
* Medical condition which prohibits not eating/drinking for 4 hours.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes