GingivitisPhase 1/2NCT02648139
A Randomized, Controlled, Double-blind Clinical Trial of Surinam Cherry Dentifrice With Anti-gingivitis Properties
A Phase 1/2 study testing Dentifrice in people with Gingivitis, run by Federal University of Paraíba.
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. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Nov 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Subjects who had used an antimicrobial in the last two months, including topical fluoride.
About this study
Official title: 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.
Read the 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
- Being tested
- Dentifrice
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DentifriceDrug
Also called Surrinam cherry dentifrice, Colgate total 12
3x/day for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and seven days
Secondary outcomes (1)
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.
Measured: Baseline and seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irlan de Almeida Freires, Federal University of Paraíba
- Investigators
- Ricardo D Castro, PhD, Principal investigator, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648139
- Sponsor's protocol ID
- Eugenia Dentifrice
- Status last verified
- Jan 2016
- First submitted
- 5 Jan 2016
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind Clinical Trial of a Eugenia Uniflora Linn. (Surinam Cherry) Dentifrice With Anti-gingivitis Properties
- ClinicalTrials.gov ID
- NCT02648139
- Acronym / sponsor ID
- Eugenia Dentifrice
- Conditions
- Gingivitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental dentifrice | Experimental | Drug: DentifriceDentifrice 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. |
| Control Dentifrice | Active comparator | Drug: DentifriceControl dentifrice - Colgate total 12 (fluoride, 1500 ppm and triclosan, 0.3%) Intervention protocol: three times per day (pea-like amount), for seven consecutive days. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who had used an antimicrobial in the last two months, including topical fluoride.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DentifriceAlso: Surrinam cherry dentifrice, Colgate total 123x/day for 7 days. | Drug | Control Dentifrice, Experimental dentifrice |
Primary outcome
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.
1 secondary outcome
Reduction in the amount of plaque
Time frame: Baseline and seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo D Castro, PhD principal investigator
Federal University of Paraíba
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dentifrice in people with Gingivitis, run by Federal University of Paraíba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in gingivitis levels (time frame: Baseline and seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.