Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count
NCT ID: NCT03108313
Last Updated: 2017-07-31
Study Results
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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UNKNOWN
PHASE2
58 participants
INTERVENTIONAL
2017-03-03
2018-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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aloe vera toothpaste
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
aloe vera toothpaste
herbal toothpaste used to decrease salivary streptococcus bacterial count
fluoride toothpaste
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
fluoride toothpaste
chemical toothpaste used to decrease salivary streptococcus bacterial count
Interventions
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aloe vera toothpaste
herbal toothpaste used to decrease salivary streptococcus bacterial count
fluoride toothpaste
chemical toothpaste used to decrease salivary streptococcus bacterial count
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients should have high bacterial count
Exclusion Criteria
* Severe or active periodontal disease .
18 Years
65 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Neven Ahmed Ebrahim
principal investigator, resident at conservative department
Principal Investigators
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Amira Farid, PHD
Role: STUDY_DIRECTOR
professor at conservative department cairo university
Rasha Rafaat, PHD
Role: STUDY_CHAIR
lecturer at conservative department cairo university
Locations
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Neven Ahmed Ebrahim
Cairo, Heliopolis, Egypt
Countries
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Central Contacts
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Facility Contacts
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Neven Ahmed Ebrahim, master
Role: primary
Neven Ahmed Ebrahim, master
Role: backup
References
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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.
Other Identifiers
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CEBC-CU-2017-30-16
Identifier Type: -
Identifier Source: org_study_id