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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648139
• Other study ID #: Eugenia Dentifrice
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 5, 2016
• Last updated: January 5, 2016
• Start date: December 2008
• Est. completion date: November 2010

Study information

• Verified date: January 2016
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Dentifrice
3x/day for 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes