Effects of Aloe Vera Toothpaste on Periodontal Parameters

Gingivitis Clinical Trial

Official title:

Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235532
• Other study ID #: IRCT2014040517053N2
• Status: Completed
• Phase: N/A
• First received: August 30, 2014
• Last updated: January 13, 2015
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 24 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingivitis

Intervention

Other:
• Foramen Herbal Aloe toothpaste
use of aloe-vera toothpaste for 30 days in the test group.
• fluoride toothpaste
use of signal toothpaste once a day for 30 days in the control group.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran Dental Branch, Islamic azad University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-2days	No
Secondary	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.	1-2 days	No
Secondary	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.	1-2 days	No