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

NCT ID: NCT02648139

Last Updated: 2016-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-11-30

Brief Summary

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.

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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dentifrice

Intervention Type: DRUG

3x/day for 7 days.

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.

Group Type: ACTIVE_COMPARATOR

Dentifrice

Intervention Type: DRUG

3x/day for 7 days.

Interventions

Dentifrice

3x/day for 7 days.

Intervention Type: DRUG

Other Intervention Names

Surrinam cherry dentifrice, Colgate total 12

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Irlan de Almeida Freires

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo D Castro, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraíba

Other Identifiers

Eugenia Dentifrice

Identifier Type: -

Identifier Source: org_study_id