Effects of Aloe Vera Toothpaste on Periodontal Parameters

NCT02235532 | Completed

• 1 other identifier: IRCT2014040517053N2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

clinical trial; oral hygiene; Gingivitis; Aloevera; Toothpaste; anti-inflammatory agents

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• measuring gingival index

  1-2 days

• measuring plaque index

  1-2 days

Study Arms (2)

Foramen Herbal Aloe toothpaste

EXPERIMENTAL

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

Other: Foramen Herbal Aloe toothpaste

use of fluoride toothpaste (signal)

ACTIVE COMPARATOR

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

Other: fluoride toothpaste

Interventions

Foramen Herbal Aloe toothpaste OTHER

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

Foramen Herbal Aloe toothpaste

fluoride toothpaste OTHER

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

Also known as: signal

use of fluoride toothpaste (signal)

Eligibility Criteria

• Age: 20 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with orthodontic appliances ,multiple bridges, partial denture, multiple caries were excluded from the study

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

Study Sites (1)

Tehran Dental Branch, Islamic azad University

Tehran, Tehran Province, 19585175, Iran

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ferena Sayar, DDS;MSc

  Tehran Dental Branch, Islamic Azad University,Tehran/Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 30, 2014
• First Posted: September 10, 2014
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

IR (1)