Background and Objectives: Toothpastes and mouthwashes are used in combination 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.
Materials and Methods: 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040517053N2
Registration date:2014-06-02, 1393/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-02, 1393/03/12
Registrant information
Name
Ferena Sayar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
f_sayar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
personal budget
Expected recruitment start date
2013-09-06, 1392/06/15
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients with Gingivitis
Public title
the effect of ALOEVERA toothpaste on gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: plaque-induced gingivitis; at least 20 teeth included in the study Exclusion criteria: systemic disease; periodontal treatment at least 6 months to the study; use of systemic antibiotic and anti-inflammatory drugs within the last 3 months; subjects with orthodontic appliances; multiple bridges; partial denture; multiple caries; smokers; pregnancy or lactating women were excluded from the study .
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental Branch-Islamic Azad University
Street address
no:4,10th neyestan st., pasdaran ave.
City
Tehran
Postal code
Approval date
2013-08-23, 1392/06/01
Ethics committee reference number
92-88
Health conditions studied
1
Description of health condition studied
gingival inflammtion
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
gingival inflammation
Timepoint
base line-after 30 days
Method of measurement
plaque and gingival indices
Secondary outcomes
empty
Intervention groups
1
Description
Control group: use of fluoride contained toothpaste for 30 days. After 2 weeks washout period, the control and test groups will be reversed.
Category
Prevention
2
Description
Test group: use of aloevera toothpast for 30 days. after 2 weeks washout period, the test and control group will be reversed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Dental Branch,Islamic Azad University
Full name of responsible person
DR.F.Sayar
Street address
department of periodontics,no:4,10th neyestan st.,pasdaran ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
none
Full name of responsible person
DR.F.Sayar
Street address
no:4,10th neyestan st.,pasdaran ave.
City
Tehran
Grant name
بودجه شخصی
Grant code / Reference number
ندارد/none
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
none
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Periodontics,Tehran Dental Branch,Islamic Azad University
Full name of responsible person
DR. F. Sayar
Position
periodontist/assistant professor
Other areas of specialty/work
Street address
department of periodontics,tehran dental branch,Islamic Azad university,no:4,10th neyestan st., pasdaran ave.
City
Tehran
Postal code
Phone
+98 21 2274 6248
Fax
Email
sayar_f@yahoo.comf_sayar@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Dental Branch,Islamic Azad University
Full name of responsible person
DR. Ferena Sayar
Position
periodontist
Other areas of specialty/work
Street address
no:4,10th neyestan st.,pasdaran ave.
City
Tehran
Postal code
Phone
+98 21 2274 6248
Fax
Email
sayar_f@yahoo.comf_sayar@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Periodontics,Tehran Dental Branch,Islamic Azad University
Full name of responsible person
DR.F.Sayar
Position
periodontist,assistant professor
Other areas of specialty/work
Street address
department of periodontics,no:4,10th neyestan st.,pasdaran ave.tehran/iran
City
Tehran
Postal code
Phone
+98 21 2274 6248
Fax
Email
sayar_f@yahoo.comf_sayar@dentaliau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)