A Randomized, Controlled, Double-blind Clinical Trial of Surinam Cherry Dentifrice With Anti-gingivitis Properties

A Randomized, Controlled, Double-blind Clinical Trial of a Eugenia Uniflora Linn. (Surinam Cherry) Dentifrice With Anti-gingivitis Properties

In the present randomized, controlled, double-blind clinical trial, we investigated the short term clinical efficacy of a dentifrice containing Eugenia uniflora L. ripe fruit extract in preventing gingivitis in children.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Dentifrice

Detailed Description

This was a randomized, controlled, double-blind clinical trial investigating the short term clinical efficacy of a dentifrice containing Eugenia uniflora L. ripe fruit extract in preventing gingivitis in children. The study consisted of a sample of 50 male and female subjects between the ages of 10 and 12 years old, who had clinical signs of gingivitis. The subjects were randomly assigned to one of two groups. The intervention group comprised 25 subjects who used the dentifrice with E. uniflora L. ripe fruit hydroalcoholic extract, three times per day, for seven consecutive days. The control group comprised 25 subjects who used the control dentifrice (fluoride, 1500 ppm and triclosan, 0.3%) for seven consecutive days.

The sample size was estimated using Fleming's single-stage procedure for phase II trials. With regard to the primary outcome, a response proportion of at least 50% was defined as being clinically significant. The type I error was set as 0.05, and the type II error was set at 0.1. Based on these values, a sample size of 20 individuals per trial arm would provide 90% power (1-β) to detect any clinically relevant treatment difference of 50% or greater compared to baseline. Taking into consideration an attrition rate of approximately 20%, the final sample size per trial arm comprised 25 individuals.

Clinical examinations were performed at baseline and after seven days of dentifrice use. The examination was performed by a single examiner who was adequately calibrated with a Kappa statistic of 0.8, which is considered to be satisfactory agreement according to Landis & Koch. The examination data were recorded in a specific clinical chart. The diagnosis of gingivitis (primary outcome) was assessed using the Gingival Bleeding Index (GBI) proposed by Ainamo and Bay. The accumulation of biofilm (secondary outcome) was assessed with the Simplified Oral Hygiene Index (OHI-S) described by Greene and Vermilion. Prior to the study, all of the subjects were instructed on correct tooth brushing techniques and received a kit that contained a toothbrush and one of the dentifrices (without the identification of its contents). The dentifrices were also masked with regard to flavor and color so that they could not be identified. In addition, the examiner had no knowledge of the subject allocation. Thus, the study was double-blind.

The sample included only subjects who had not used an antimicrobial in the last two months, including topical fluoride.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged 10 to 12 years old with clinical signs of gingivitis (bleeding on probing);
• Presence of at least 20 dental elements
• Not using orthodontic fixed appliances
• Susceptibility to form biofilm and gingival inflammation
• Absence of systemic disease

Exclusion Criteria:

- Subjects who had used an antimicrobial in the last two months, including topical fluoride.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental dentifrice; Dentifrice containing the extract of Eugenia uniflora rip fruit. Each 10 ml of E. uniflora L. dentifrice comprises the following components: Hydroalcoholic extract of the ripe fruit of E. uniflora L. (3.0%), preservatives (parabens; 0.02 g), and dentifrice base (silicon dioxide, sodium lauryl sulfate, white dye, aromatic compounds, sodium saccharin, and Gangrez sodium salt; q.s.p.). Intervention protocol: three times per day (pea-like amount), for seven consecutive days.	Drug: Dentifrice; 3x/day for 7 days.; Other Names: Surrinam cherry dentifrice, Colgate total 12
Active Comparator: Control Dentifrice; Control dentifrice - Colgate total 12 (fluoride, 1500 ppm and triclosan, 0.3%) Intervention protocol: three times per day (pea-like amount), for seven consecutive days.	Drug: Dentifrice; 3x/day for 7 days.; Other Names: Surrinam cherry dentifrice, Colgate total 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in gingivitis levels	The primary outcome of interest was the reduction in the levels of gingivitis (bleeding on probing) assessed by the Gingival Bleeding Index (GBI) proposed by Ainamo and Bay.	Baseline and seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the amount of plaque	The secondary outcome of interest was the reduction in the amount of plaque assessed by the Simplified Oral Hygiene Index (OHI-S) described by Greene and Vermilion.	Baseline and seven days

Collaborators and Investigators

• Sponsor: Federal University of Paraíba
• Investigators: Principal Investigator: Ricardo D Castro, PhD, Federal University of Paraiba

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Estimate): January 6, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: Eugenia Dentifrice

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No