Back to resultsEffects of Aloe Vera Toothpaste on Periodontal Parameters
Primary Purpose
Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Foramen Herbal Aloe toothpaste
fluoride toothpaste
Sponsored by
About this trial
This is an interventional prevention trial for Gingivitis focused on measuring clinical trial, oral hygiene, Gingivitis, Aloevera, Toothpaste, anti-inflammatory agents
Eligibility Criteria
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
Sites / Locations
- Tehran Dental Branch, Islamic azad University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Foramen Herbal Aloe toothpaste
use of fluoride toothpaste (signal)
Arm Description
test group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day.
use of a fluoride toothpaste (signal) in control group once a day for 30 days .
Outcomes
Primary Outcome Measures
measuring gingival index
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.
Secondary Outcome Measures
measuring gingival index
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.
measuring plaque index
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.
Full Information
NCT ID
NCT02235532
First Posted
August 30, 2014
Last Updated
January 13, 2015
Sponsor
Islamic Azad University, Tehran
1. Study Identification
Unique Protocol Identification Number
NCT02235532
Brief Title
Effects of Aloe Vera Toothpaste on Periodontal Parameters
Official Title
Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Tehran
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
clinical trial, oral hygiene, Gingivitis, Aloevera, Toothpaste, anti-inflammatory agents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Foramen Herbal Aloe toothpaste
Arm Type
Experimental
Arm Description
test group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day.
Arm Title
use of fluoride toothpaste (signal)
Arm Type
Active Comparator
Arm Description
use of a fluoride toothpaste (signal) in control group once a day for 30 days .
Intervention Type
Other
Intervention Name(s)
Foramen Herbal Aloe toothpaste
Intervention Description
use of aloe-vera toothpaste for 30 days in the test group.
Intervention Type
Other
Intervention Name(s)
fluoride toothpaste
Other Intervention Name(s)
signal
Intervention Description
use of signal toothpaste once a day for 30 days in the control group.
Primary Outcome Measure Information:
Title
measuring gingival index
Description
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.
Time Frame
1-2days
Secondary Outcome Measure Information:
Title
measuring gingival index
Description
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.
Time Frame
1-2 days
Title
measuring plaque index
Description
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.
Time Frame
1-2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferena Sayar, DDS;MSc
Organizational Affiliation
Tehran Dental Branch, Islamic Azad University,Tehran/Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran Dental Branch, Islamic azad University
City
Tehran
ZIP/Postal Code
19585175
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Aloe Vera Toothpaste on Periodontal Parameters
We'll reach out to this number within 24 hrs