A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

Study Overview
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Brief Summary
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This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.

Official Title
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A Controlled Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

Conditions
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Dental Plaque, Dental Gingivitis

Intervention / Treatment
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* Drug: China Crest® Pro-health 7 Complete Toothpaste
* Drug: China Crest® Cavity Protection Toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: give written informed consent prior to their participation; be 18 to 65 years of age at the time of enrollment; agree not to participate in any other oral/dental product studies; agree to delay any elective dentistry (including a dental prophylaxis); agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study; agree to return for the scheduled visits and follow study procedures; be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study; have more than 10 bleeding sites at visits 1-3 Consistency of bleeding site number at baseline may be considered; have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment. Exclusion Criteria: teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam medical conditions that the investigator considers significant and that may compromise the evaluation of study results currently participating in any other clinical trial participated in a clinical trial for plaque/gingivitis within the previous 30 days pregnant or lactating orthodontic appliances or removable partial dentures soft or hard tissue tumor of the oral cavity advanced periodontal disease history of hepatitis, diabetes, or other communicable diseases history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures history of significant adverse effects following the use of oral hygiene products such as toothpaste oral pathoses that could interfere with compliance and/or examinations or that need treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Oral care regimen | Drug: China Crest® Pro-health 7 Complete Toothpaste<br>* Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse<br>|
| Placebo Comparator: Control Group<br>Toothbrush and toothpaste | Drug: China Crest® Cavity Protection Toothpaste<br>* Crest® meliliangje manual toothbrush<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingivitis | Gingivitis was assessed according to the Gingival Bleeding Index | Day 0 | 
| Gingivitis | Gingivitis was assessed according to the Gingival Bleeding Index | Day 3 | 
| Gingivitis | Gingivitis was assessed according to the Gingival Bleeding Index | Day 10 | 
| Gingivitis | Gingivitis was assessed according to the Gingival Bleeding Index | Day 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Examination | The Modified Turesky Plaque Index was used to examine plaque. | Day 0 | 
| Plaque Examination | The Modified Turesky Plaque Index was used to examine plaque. | Day 3 | 
| Plaque Examination | The Modified Turesky Plaque Index was used to examine plaque. | Day 10 | 
| Plaque Examination | The Modified Turesky Plaque Index was used to examine plaque. | Day 24 |