Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count
Primary Purpose
Caries, Dental
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
aloe vera toothpaste
fluoride toothpaste
Sponsored by
About this trial
This is an interventional prevention trial for Caries, Dental
Eligibility Criteria
Inclusion Criteria:
- Patients should have poor oral hygiene.
- Patients should have high bacterial count
Exclusion Criteria:
- Patients with a compromised medical history.
- Severe or active periodontal disease .
Sites / Locations
- Neven Ahmed EbrahimRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aloe vera toothpaste
fluoride toothpaste
Arm Description
aloe vera toothpaste isa will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days
fluoride toothpaste isa herbal toothpaste will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days
Outcomes
Primary Outcome Measures
salivary bacterial count
will be done using mitis salivarius agar plate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03108313
Brief Title
Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count
Official Title
Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count :Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
April 30, 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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patient's salivary bacterial count will be evaluated , then the patient will bbe instructed to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be evaluated another time.
Detailed Description
Variables of study:
Each patient will be instructed to follow oral hygiene measures including aloe vera or fluoride toothpaste
Outcomes:
Salivary bacterial count will be evaluated using Mitis salivarius agar plates before the use of the aloe vera toothpaste then after 15 days then after 30 days .
Participant timeline:
Enrolment Baseline assessment 15 days 30 days
(1st visit ) (2nd visit) (3rd visit )
II.6.Sample size calculation :
Based on previous study , the mean percent change reduction in bacterial count was 3+4 . using power 80 % and 5 % significance level , we will need to study 29 in each group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I probability associated with this test of this null hypothesis is 0.05.
Recruitment & Recruitment Strategy:
Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients will be subjected to full examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. Randomization and assignment of interventions:
Randomization will be done according to a check list including the number of participants divided into 2 groups according to interventions/Control assessment method
Allocation sequence generation:
The allocation sequence will be generated using (www.randomization.com).
Allocation concealment mechanism:
A checklist will be designed to identify each assessment method.
Implementation A participant will generate the random allocation sequence. The researcher will enroll the patients but an unbiased participant will assign the intervention/Control identification procedures to respective teeth.
Blinding:
The participants will be blinded to intervention/control assessment methods. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.
Data collection methods:
High caries index will be assessed 3 times , at base line , then 15 days and 30 days.
Funding:
The research will be self-funded by the researcher.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
A participant will generate the random allocation sequence. The researcher will enroll the patients but an unbiased participant will assign the intervention/Control identification procedures .The participants will be blinded to intervention/control assessment methods. Also, it will not be allowed among the examiners to exchange any information throughout the entire study period.
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aloe vera toothpaste
Arm Type
Experimental
Arm Description
aloe vera toothpaste isa will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days
Arm Title
fluoride toothpaste
Arm Type
Active Comparator
Arm Description
fluoride toothpaste isa herbal toothpaste will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days
Intervention Type
Drug
Intervention Name(s)
aloe vera toothpaste
Other Intervention Name(s)
aloe dent toothpaste, aloe dent
Intervention Description
herbal toothpaste used to decrease salivary streptococcus bacterial count
Intervention Type
Drug
Intervention Name(s)
fluoride toothpaste
Other Intervention Name(s)
signal toothpaste
Intervention Description
chemical toothpaste used to decrease salivary streptococcus bacterial count
Primary Outcome Measure Information:
Title
salivary bacterial count
Description
will be done using mitis salivarius agar plate
Time Frame
average of 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients should have poor oral hygiene.
Patients should have high bacterial count
Exclusion Criteria:
Patients with a compromised medical history.
Severe or active periodontal disease .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neven Ahmed Ebrahim, master
Phone
01153621944
Email
nova480@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Neven Ahmed Ebrahim, master
Phone
01005475566
Email
Dr.mohamedsabry90@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Farid, PHD
Organizational Affiliation
professor at conservative department cairo university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasha Rafaat, PHD
Organizational Affiliation
lecturer at conservative department cairo university
Official's Role
Study Chair
Facility Information:
Facility Name
Neven Ahmed Ebrahim
City
Cairo
State/Province
Heliopolis
ZIP/Postal Code
11311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neven Ahmed Ebrahim, master
Phone
01153621944
Email
nova480@yahoo.com
First Name & Middle Initial & Last Name & Degree
Neven Ahmed Ebrahim, master
Phone
01005475566
Email
Dr.mohamedsabry90@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
publishing the data at egyptian dental journal
Citations:
PubMed Identifier
26539392
Citation
Bhati N, Jaidka S, Somani R. Evaluation of antimicrobial efficacy of Aloe vera and Meswak containing dentifrices with fluoridated dentifrice: An in vivo study. J Int Soc Prev Community Dent. 2015 Sep-Oct;5(5):394-9. doi: 10.4103/2231-0762.165924.
Results Reference
background
Learn more about this trial
Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count
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