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

NCT02648139 | Completed Phase 1 DMC

• 1 other identifier: Eugenia Dentifrice
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction in the amount of plaque

  Baseline and seven days

Study Arms (2)

Experimental dentifrice

EXPERIMENTAL

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

Control Dentifrice

ACTIVE COMPARATOR

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

Interventions

Dentifrice DRUG

3x/day for 7 days.

Also known as: Surrinam cherry dentifrice, Colgate total 12

Control Dentifrice; Experimental dentifrice

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Paraíba: lead

MeSH Terms

Conditions

Gingivitis

Interventions

Dentifrices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ricardo D Castro, PhD

  Federal University of Paraíba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 6, 2016
• Study Start: December 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 6, 2016

Record last verified: 2016-01