Dental PlaquePhase 4NCT02695901
Effect of Different Mouthrinses in Plaque Formation
A Phase 4 study testing Chlorhexidine gluconate 0.12% (PerioGard®) and Nanoparticle solution of M. alternifolia oil (0.3%). in people with Dental Plaque, run by Universidade Federal de Santa Maria.
Trial summary
Although several studies have assessed the efficacy of chlorhexidine in treating gingivitis and reducing biofilm formation, the side effects of a long-term use are unpleasant for patients. Melaleuca alternifolia oil has been considered as an alternative because of its anti-inflammatory properties. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Chlorhexidine gluconate 0.12% (PerioGard®) and Nanoparticle solution of M. alternifolia oil (0.3%).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- Phase
- Phase 4
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals must be systemically healthy;
- Must have at least six teeth per quadrant;
- Must not be undergoing medical treatment;
Who cannot join
- Allergies or hypersensitivity to the components (Chlorhexidine Gluconate or M. alternifolia oil nanoparticles);
- Antibiotic therapy within 3 months prior to baseline examination;
- History of periodontal disease;
- Marginal bleeding index higher than 15%;
- Oral mucosal lesions;
- Pregnancy or breastfeeding;
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- Presence of active infectious foci (endodontic abscesses);
- Presence of plaque retentive factors (caries, aesthetic or ill-fitting restorations, orthodontic appliances, fixed or removable prosthesis);
- Smokers;
- Systemic conditions (diabetes, immunosuppression);
- Use of any mouthwash within 21 days prior to baseline examination;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anti-plaque Effect of 0.12% Chlorhexidine Gluconate Rinsing and Nanoparticle Solution of 0.3% Melaleuca Alternifolia: A Randomized Crossover Clinical Trial
Although several studies have assessed the efficacy of chlorhexidine in treating gingivitis and reducing biofilm formation, the side effects of a long-term use are unpleasant for patients. Melaleuca alternifolia oil has been considered as an alternative because of its anti-inflammatory properties. However, little is know about the efficacy of its nanoparticles. The purpose of this study is to compare the effect of 0.12% chlorhexidine (Periogard ®) and a nanoparticle solution of 0.3% M. alternifolia oil in reducing biofilm formation in plaque-free and plaque-covered teeth surfaces.
Read the detailed description
This will be a randomized crossover clinical trial, double blind, in which individuals will be randomly assigned into two different treatments: daily mouthrinse of chlorhexidine gluconate (0.12%) or daily mouthrinse of a nanoparticle solution of M. alternifolia (0.3%) during a period of oral hygiene withdrawal.
The test panel will consist of 59 students from the Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. All subjects will receive written and oral explanations regarding the purpose and design of this study. Those who met the inclusion criteria will be selected for a dental screening appointment, being removed in the presence of any exclusion criteria. All volunteers will be asked to sign an informed consent before the experimental period.
The following clinical parameters will be assessed:
- Plaque index (PI) Quigley and Hein modified by Turesky.
- Gingival crevicular fluid (GCF) will be measured with an electronic gingival fluid measuring device (Periotron®).
- Gingival abrasion (GA) using 2-Tone disclosing solution.
- Perception of appreciation (Questionnaire-VAS scale). Descriptive analysis of PI data will be performed using averages, standard deviations and average percentage of sites with different PI scores. The normal distribution of the data will be evaluated by the Kolmogorov-Smirnov test. Analysis of variance (ANOVA) with repeated measures will be used to test for differences between groups. Paired student's t-test will be conducted to test whether there were significant differences between the baseline measurements of PI, GA, GCF and perception of appreciation after the use of mouthwash. The statistical tests will be performed using the program SPSS 20.0 (Statistical Package for the Social Sciences, Chicago, USA).
- Conditions
- Dental Plaque
- Being tested
- Chlorhexidine gluconate 0.12% (PerioGard®), Nanoparticle solution of M. alternifolia oil (0.3%).
- Keywords
- Plaque index, Melaleuca alternifolia oil., Nanoparticles
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconate 0.12% (PerioGard®)Drug
At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%). Plaque indices will be recorded at baseline, day 4, and day 7.
Nanoparticle solution of M. alternifolia oil (0.3%).Drug
At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing a nanoparticle solution of M. alternifolia oil (0.3%). Plaque indices will be recorded at baseline, day 4, and day 7.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine gluconate (0,12%) | Experimental | Subjects will rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%). Receives: Drug: Chlorhexidine gluconate 0.12% (PerioGard®) |
| M. alternifolia oil (Nanoparticle solution) | Experimental | Subjects will rinse twice daily with 15 ml mouthrinse containing nanoparticles of M. alternifolia oil (0.3%). Receives: Drug: Nanoparticle solution of M. alternifolia oil (0.3%). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental plaque/biofilm formation.
Measured: 7 days.
Secondary outcomes (1)
Gingival abrasion.
Measured: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Dental PlaqueStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitário Franciscano
- Responsible party
- Principal investigator, Maísa Casarin, Universidade Federal de Santa Maria
- Investigators
- Fabricio B. Zanatta, PhD, Study director, Adjunct Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695901
- Sponsor's protocol ID
- 52275816.0.0000.5346
- Other IDs
- 1.399.643
- Status last verified
- Feb 2016
- First submitted
- 21 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
Publications
Rahman B, Alkawas S, Al Zubaidi EA, Adel OI, Hawas N. Comparative antiplaque and antigingivitis effectiveness of tea tree oil mouthwash and a cetylpyridinium chloride mouthwash: A randomized controlled crossover study. Contemp Clin Dent. 2014 Oct;5(4):466-70. doi: 10.4103/0976-237X.142813.
PubMed 25395761
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-plaque Effect of 0.12% Chlorhexidine Gluconate Rinsing and Nanoparticle Solution of 0.3% Melaleuca Alternifolia: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT02695901
- Acronym / sponsor ID
- 52275816.0.0000.5346
- Conditions
- Dental Plaque
- Keywords
- Plaque index, Melaleuca alternifolia oil., Nanoparticles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Collaborators
- Centro Universitário Franciscano
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Mar 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.
Although several studies have assessed the efficacy of chlorhexidine in treating gingivitis and reducing biofilm formation, the side effects of a long-term use are unpleasant for patients. Melaleuca alternifolia oil has been considered as an alternative because of its anti-inflammatory properties. However, little is know about the efficacy of its nanoparticles. The purpose of this study is to compare the effect of 0.12% chlorhexidine (Periogard ®) and a nanoparticle solution of 0.3% M. alternifolia oil in reducing biofilm formation in plaque-free and plaque-covered teeth surfaces.
Detailed description
This will be a randomized crossover clinical trial, double blind, in which individuals will be randomly assigned into two different treatments: daily mouthrinse of chlorhexidine gluconate (0.12%) or daily mouthrinse of a nanoparticle solution of M. alternifolia (0.3%) during a period of oral hygiene withdrawal.
The test panel will consist of 59 students from the Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. All subjects will receive written and oral explanations regarding the purpose and design of this study. Those who met the inclusion criteria will be selected for a dental screening appointment, being removed in the presence of any exclusion criteria. All volunteers will be asked to sign an informed consent before the experimental period.
The following clinical parameters will be assessed:
- Plaque index (PI) Quigley and Hein modified by Turesky.
- Gingival crevicular fluid (GCF) will be measured with an electronic gingival fluid measuring device (Periotron®).
- Gingival abrasion (GA) using 2-Tone disclosing solution.
- Perception of appreciation (Questionnaire-VAS scale). Descriptive analysis of PI data will be performed using averages, standard deviations and average percentage of sites with different PI scores. The normal distribution of the data will be evaluated by the Kolmogorov-Smirnov test. Analysis of variance (ANOVA) with repeated measures will be used to test for differences between groups. Paired student's t-test will be conducted to test whether there were significant differences between the baseline measurements of PI, GA, GCF and perception of appreciation after the use of mouthwash. The statistical tests will be performed using the program SPSS 20.0 (Statistical Package for the Social Sciences, Chicago, USA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate (0,12%) | Experimental | Drug: Chlorhexidine gluconate 0.12% (PerioGard®)Subjects will rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%). |
| M. alternifolia oil (Nanoparticle solution) | Experimental | Drug: Nanoparticle solution of M. alternifolia oil (0.3%).Subjects will rinse twice daily with 15 ml mouthrinse containing nanoparticles of M. alternifolia oil (0.3%). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals must be systemically healthy;
- Must have at least six teeth per quadrant;
- Must not be undergoing medical treatment;
Key exclusion criteria (11 listed)
- Allergies or hypersensitivity to the components (Chlorhexidine Gluconate or M. alternifolia oil nanoparticles);
- Antibiotic therapy within 3 months prior to baseline examination;
- History of periodontal disease;
- Marginal bleeding index higher than 15%;
- Oral mucosal lesions;
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 |
|---|---|---|
| Chlorhexidine gluconate 0.12% (PerioGard®)At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%). Plaque indices will be recorded at baseline, day 4, and day 7. | Drug | Chlorhexidine gluconate (0,12%) |
| Nanoparticle solution of M. alternifolia oil (0.3%).At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing a nanoparticle solution of M. alternifolia oil (0.3%). Plaque indices will be recorded at baseline, day 4, and day 7. | Drug | M. alternifolia oil (Nanoparticle solution) |
Primary outcome
Dental plaque/biofilm formation.
Time frame: 7 days.
1 secondary outcome
Gingival abrasion.
Time frame: 7 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Background: PubMed 25395761Rahman B, Alkawas S, Al Zubaidi EA, Adel OI, Hawas N. Comparative antiplaque and antigingivitis effectiveness of tea tree oil mouthwash and a cetylpyridinium chloride mouthwash: A randomized controlled crossover study. Contemp Clin Dent. 2014 Oct;5(4):466-70. doi: 10.4103/0976-237X.142813.
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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.
Fabricio B. Zanatta, PhD study director
Adjunct Professor
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine gluconate 0.12% (PerioGard®) and Nanoparticle solution of M. alternifolia oil (0.3%). in people with Dental Plaque, run by Universidade Federal de Santa Maria.
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 3 inclusion and 11 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 1 Mar 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Fabricio B. Zanatta, PhD (+55 55 81283358, fabriciobzanatta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental plaque/biofilm formation. (time frame: 7 days.). 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 NCT02695901, 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 1 Mar 2016.