GingivitisPhase 1/2NCT01197105
Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children
A Phase 1/2 study testing Use of natural product (Schinus terebinthifolius) in people with Gingivitis and Plaque Accumulation, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (Schinus terebinthifolius) used by children with gingivitis. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Gingivitis, Plaque Accumulation
- What is being tested?
- Use of natural product (Schinus terebinthifolius)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Sep 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
- Age group: 10-12 years old
- Presence of at least 20 dental elements
- Do not use orthodontic fixed appliances
- Simplified Oral Hygiene Index (S-OHI) is greater than 2
- Levels of Microbiological Streptococcus mutans in saliva high (> 10,000 CFU / mL) (JENSEN; BRATTHALL, 1989)
- Susceptibility to form biofilm and gingival inflammation
- Absence of systemic disease
- Not be under the use of antiseptic mouthwash in the last 3 months
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Francisco Campos Statal School
João Pessoa, Paraíba, 58.052-080
Maria José, Director, 558332354184
Irlan de Almeida Freires, undergraduate dental student
About this study
Official title: Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis
The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (Schinus terebinthifolius) used by children with gingivitis.
- Conditions
- Gingivitis, Plaque Accumulation
- Being tested
- Use of natural product (Schinus terebinthifolius)
- Keywords
- gingivitis, schinus terebinthifolius, natural products
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of natural product (Schinus terebinthifolius)Biological
Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Aroeira | Experimental | Not described Receives: Biological: Use of natural product (Schinus terebinthifolius) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival inflammation (Blood gingival index)
In this time frame will be assessed the initial gingival inflammation in children.
Measured: baseline
Plaque amount
In this time will be assessed the initial oral hygiene condition of the children before the use of the product through the Simplified Oral Hygiene Index.
Measured: Baseline
Secondary outcomes (4)
Gingival inflammation (Blood gingival Index)
In this time frame will be assessed the gingival inflammation in children after 7 days using the product.
Measured: After 7 days (t1)
Gingival inflammation (blood gingival index)
In this time frame will be assessed the final condition of the children after 14 days using the product.
Measured: After 14 days (t2)
Plaque amount
In this time will be assessed the oral hygiene condition of the children after 7 days using the product (Through Simplified Oral Hygiene Index).
Measured: After 7 days (t1)
Plaque amount
In this time will be assessed the final oral hygiene condition of the children after 14 days using the product (through the Simplified Oral Hygiene Index).
Measured: After 14 days (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197105
- Sponsor's protocol ID
- ACTG 2612
- Status last verified
- Sep 2010
- First submitted
- 7 Sep 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
PubMed 14076341
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis
- ClinicalTrials.gov ID
- NCT01197105
- Acronym / sponsor ID
- ACTG 2612
- Conditions
- Gingivitis, Plaque Accumulation
- Keywords
- gingivitis, schinus terebinthifolius, natural products
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2010 (actual)
- First posted
- 9 Sep 2010 (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.
The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (Schinus terebinthifolius) used by children with gingivitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aroeira | Experimental | Biological: Use of natural product (Schinus terebinthifolius) |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age group: 10-12 years old
- Presence of at least 20 dental elements
- Do not use orthodontic fixed appliances
- Simplified Oral Hygiene Index (S-OHI) is greater than 2
- Levels of Microbiological Streptococcus mutans in saliva high (> 10,000 CFU / mL) (JENSEN; BRATTHALL, 1989)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Use of natural product (Schinus terebinthifolius)Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days. | Biological | Aroeira |
Primary outcome
Gingival inflammation (Blood gingival index)
Time frame: baseline
In this time frame will be assessed the initial gingival inflammation in children.
Plaque amount
Time frame: Baseline
In this time will be assessed the initial oral hygiene condition of the children before the use of the product through the Simplified Oral Hygiene Index.
4 secondary outcomes
Gingival inflammation (Blood gingival Index)
Time frame: After 7 days (t1)
Gingival inflammation (blood gingival index)
Time frame: After 14 days (t2)
Plaque amount
Time frame: After 7 days (t1)
Plaque amount
Time frame: After 14 days (t2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
- Background: PubMed 14076341GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Use of natural product (Schinus terebinthifolius) in people with Gingivitis and Plaque Accumulation, run by Federal University of Paraíba at 1 site in Brazil.
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 8 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: status not confirmed, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival inflammation (Blood gingival index) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197105, which also lists 1 linked publication.
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 9 Sep 2010.