- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02235532
Effects of Aloe Vera Toothpaste on Periodontal Parameters
Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis
This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.
The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days . This order was reversed in group 2.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Toothpastes are used with tooth brushing to better control microbial plaque. Herbal toothpastes have recently gained attention. This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.
This single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days and then their plaque index (PI) and gingival index (GI) were recorded. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days and underwent PI and GI assessment again. This order was reversed in group 2. Wilcoxon-Sign Rank and two way Repeated Measure ANOVA tests were applied for statistical analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tehran, Iran, Islamic Republic of, 19585175
- Tehran Dental Branch, Islamic azad University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects were selected among dental students with at least 20 natural teeth without systemic disease
- No periodontal treatment at least 6 months to the study
- No use of systemic antibiotic and anti-inflammatory drugs within the last 3 months, nonsmokers, no pregnancy or lactating women
- Subjects with PD≤3mm, (clinical attachment level)CAL<1mm, PI≥2 and gingival bleeding in more than 30% of the tested areas were enrolled with the diagnosis of plaque-related gingivitis.
Exclusion Criteria:
- Subjects with orthodontic appliances ,multiple bridges, partial denture, multiple caries were excluded from the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Foramen Herbal Aloe toothpaste
test group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day.
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use of aloe-vera toothpaste for 30 days in the test group.
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Active Comparator: use of fluoride toothpaste (signal)
use of a fluoride toothpaste (signal) in control group once a day for 30 days .
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use of signal toothpaste once a day for 30 days in the control group.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measuring gingival index
Time Frame: 1-2days
|
to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
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1-2days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measuring gingival index
Time Frame: 1-2 days
|
to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
|
1-2 days
|
measuring plaque index
Time Frame: 1-2 days
|
to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the plaque index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
|
1-2 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ferena Sayar, DDS;MSc, Tehran Dental Branch, Islamic Azad University,Tehran/Iran
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRCT2014040517053N2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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