Back to resultsEfficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
arginine toothpaste
fluoride toothpaste
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Participants should be over 18 years of age.
- Systematically healthy.
- Not taking any medication interfering with saliva secretion.
- Participants who signed informed consent.
Exclusion Criteria:
- Participants with a compromised medical history.
- Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
- Severe or active periodontal disease.
- History of allergies or other adverse reactions to arginine, or oral care product or their ingredient.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
arginine toothpaste
fluoride toothpaste
Arm Description
Outcomes
Primary Outcome Measures
salivary pH
Salivary pH will be determined by use of a digital pH meter .All salivary pH values will be taken immediately following salivary collection at chairside. The salivary pH values measured before usage of toothpaste termed "resting pH," while the salivary pH values measured after usage of toothpaste termed "terminal pH.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03143023
Brief Title
Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid
Official Title
Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid Using Chair Side(Potential of Hydrogen) pH Meter Assessment Method in Adult Population: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will be conducted to evaluate the effect of arginine versus fluoride containing toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult population using chair side assessment method.
Detailed Description
.28 volunteer participants will be assigned in this study. Participants will be randomly divided into two groups(n=14) according to type of toothpaste D where groups D1 patient will use arginine containing toothpaste while groups D2 the patient will used the fluoride toothpaste with a number of 14 patients in each group. The pH will be evaluated according to time in relation to the brushing with toothpaste (T) where (T0) represent salivary pH before brushing with toothpaste , (T1) represent salivary pH 10 minutes after brushing with toothpaste at fixed time of the day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
arginine toothpaste
Arm Type
Experimental
Arm Title
fluoride toothpaste
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
arginine toothpaste
Intervention Description
acid neutralizer toothpaste
Intervention Type
Drug
Intervention Name(s)
fluoride toothpaste
Intervention Description
bactericidal toothpaste
Primary Outcome Measure Information:
Title
salivary pH
Description
Salivary pH will be determined by use of a digital pH meter .All salivary pH values will be taken immediately following salivary collection at chairside. The salivary pH values measured before usage of toothpaste termed "resting pH," while the salivary pH values measured after usage of toothpaste termed "terminal pH.
Time Frame
10 minutes after intervention and control
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants should be over 18 years of age.
Systematically healthy.
Not taking any medication interfering with saliva secretion.
Participants who signed informed consent.
Exclusion Criteria:
Participants with a compromised medical history.
Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
Severe or active periodontal disease.
History of allergies or other adverse reactions to arginine, or oral care product or their ingredient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
laura yehia zanati, master
Phone
01204470007
Email
laura_lola92@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
aya mohamed adly, master
Phone
012215228843
Email
adly_sweetdentist@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid
We'll reach out to this number within 24 hrs