Effects of Aloe Vera Toothpaste on Periodontal Parameters

NCT ID: NCT02235532

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Foramen Herbal Aloe toothpaste

test group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day.

Group Type: EXPERIMENTAL

Foramen Herbal Aloe toothpaste

Intervention Type: OTHER

use of aloe-vera toothpaste for 30 days in the test group.

use of fluoride toothpaste (signal)

use of a fluoride toothpaste (signal) in control group once a day for 30 days .

Group Type: ACTIVE_COMPARATOR

fluoride toothpaste

Intervention Type: OTHER

use of signal toothpaste once a day for 30 days in the control group.

Interventions

Foramen Herbal Aloe toothpaste

use of aloe-vera toothpaste for 30 days in the test group.

Intervention Type: OTHER

fluoride toothpaste

use of signal toothpaste once a day for 30 days in the control group.

Intervention Type: OTHER

Other Intervention Names

signal

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Islamic Azad University, Sanandaj

OTHER

Sponsor Role: lead

Responsible Party

Ferena Sayar

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferena Sayar, DDS;MSc

Role: PRINCIPAL_INVESTIGATOR

Tehran Dental Branch, Islamic Azad University,Tehran/Iran

Locations

Tehran Dental Branch, Islamic azad University

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

IRCT2014040517053N2

Identifier Type: -

Identifier Source: org_study_id