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

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ClinicalTrials.gov Identifier: NCT02648139
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Irlan de Almeida Freires, Federal University of Paraíba

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.

Condition or disease Intervention/treatment Phase
Gingivitis Drug: Dentifrice Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-blind Clinical Trial of a Eugenia Uniflora Linn. (Surinam Cherry) Dentifrice With Anti-gingivitis Properties
Study Start Date : December 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Listerine

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 Name: 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 Name: Surrinam cherry dentifrice, Colgate total 12




Primary Outcome Measures :
  1. Reduction in gingivitis levels [ Time Frame: Baseline and seven days ]
    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.


Secondary Outcome Measures :
  1. Reduction in the amount of plaque [ Time Frame: Baseline and seven days ]
    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.



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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648139


Sponsors and Collaborators
Federal University of Paraíba
Investigators
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Principal Investigator: Ricardo D Castro, PhD Federal University of Paraíba

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Responsible Party: Irlan de Almeida Freires, PhD, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT02648139     History of Changes
Other Study ID Numbers: Eugenia Dentifrice
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Sodium Fluoride
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents