GingivitisPhase 4MOUORTNCT03179735
Mouthwashes During Orthodontic Treatment
A Phase 4 study testing Essential oils and Cetylpyridinium Chloride 0.7 mg/ml in people with Gingivitis, run by University of Taubate at 1 site in Brazil.
Trial summary
The number of orthodontic treatment provided to Brazilian population has been increased. Unfortunately, some negative effects such as gum bleeding and bad breath are commonly observed. It partially happens because tooth brushing and flossing become more difficult in the presence of braces. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Essential oils and Cetylpyridinium Chloride 0.7 mg/ml
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 10 Jul 2018
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health;
- class I or class II malocclusions with a nonsurgical orthodontic treatment plan for alignment and leveling including no-extraction, extraction of two upper premolars or extraction of four premolars; no previous orthodontic treatment; overbite and overjet that allowed brackets to be placed on the lower teeth without occlusal interferences;
- periodontal health (with no clinical signals of inflammation, GI <1 e no clinical attachment loss);
- at least 26 natural teeth;
Who cannot join
- severe skeletal malocclusion in anteroposterior, vertical or transverse dimensions; surgical orthodontic plan;
- mouth breathing;
- gingivitis; periodontitis; gingival overgrowth;
- prosthetic fixed devices, removable partial dentures or overhanging restorations;
- systemic diseases or conditions that could influence the periodontal status;
- smokers and former-smokers;
Show all 12Show fewer
- pregnancy or breast-feeding;
- history of sensitivity or suspected allergies following the use of oral hygiene products; any antibiotic prophylaxis;
- antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study;
- regular use of chemotherapeutic antiplaque/antigingivitis products;
- periodontal treatment performed within six months prior to study initiation;
- unwillingness to return for follow-up.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Nucleus of periodontal research of University of Taubate
Taubaté, São Paulo, 12020330
About this study
Official title: Mouthwashes as Positive Modulators of Periodontal Response During Orthodontic Treatment: a 6-month Randomized Placebo Controlled Clinical Trial
The number of orthodontic treatment provided to Brazilian population has been increased. Unfortunately, some negative effects such as gum bleeding and bad breath are commonly observed. It partially happens because tooth brushing and flossing become more difficult in the presence of braces. Therefore, there is a need for clinical protocols able to maintain the mouth healthy during orthodontic treatment.
Considering that proper use of mouthwashes by in individuals without braces is accompanied by decrease in plaque and gum inflammation levels, it was hypothesized that, during orthodontic treatment their anti-gingivitis and anti-plaque properties would positively affect oral health. Objectives: The present study will compare the effects of two commercially available mouthwashes with a placebo mouthwash in orthodontic patients wearing fixed appliances.
Whole-mouth clinical examinations will be performed in periodontally healthy patients 15 days before, at the day of bonding and also 3 and 6 months after braces bonding. Hard and soft tissues status, presence of gingivitis and amount of dental plaque will be monitored to determine mouthwashes efficacy. At these same time-points plaque samples will be collected from dental sites and braces surfaces aiming at determining total levels of bacteria and levels of specific bacteria related to gum disease. After a full-mouth ultrasonic debridement to remove dental plaque, stains and tartar, patients will be randomly assigned to an Essential oils, Cetylpyridinium chloride or a placebo mouthwash for 6 months (40 ml/day). Further, samples of orthodontic wires will be analyzed under microscopy to check whether regular use of mouthwashes increases the risk of corrosion or not.
- Conditions
- Gingivitis
- Being tested
- Essential oils, Cetylpyridinium Chloride 0.7 mg/ml, Placebos
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential oilsDrug
Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home.
First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding.
Cetylpyridinium Chloride 0.7 mg/mlDrug
Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home.
First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding.
PlacebosDrug
Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home.
First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding.
| Study group | Role | What they receive |
|---|---|---|
| Essential oils mouthwash | Experimental | Essential-oils group will rinse with an alcohol-free mouthwash (twice daily use; 20 ml/30 s) containing a fixed combination of four essential oils (eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%) Receives: Drug: Essential oils |
| Cetylpyridinium mouthwash | Experimental | Cetylpyridinium chloride group will rinse with an alcohol-free mouthwash (twice daily use; 20 ml/30 s) containing cetylpyridinium chloride 0.7 mg/ml Receives: Drug: Cetylpyridinium Chloride 0.7 mg/ml |
| Placebos mouthwash | Placebo comparator | Placebo group will rinse with an alcohol-free placebo solution (twice daily use; 20 ml/30 s) Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gingival index
Gingival index changes (mean scores) from baseline to 6 months.
Measured: up to 6 months
Secondary outcomes (5)
Changes in plaque index
Plaque index changes (mean scores) from baseline to 6 months.
Measured: up to 6 months
Changes in subgingival bacterial levels
Changes in bacterial levels (total number of bacterial cells and specific numbers of Actinomyces naeslundii, Streptococcus oralis, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola) from sub gingival samples.
Measured: up to 6 months
Changes in bracket bacterial levels
Changes in bacterial levels (total number of bacterial cells and specific numbers of Actinomyces naeslundii, Streptococcus oralis, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola) from bracket samples.
Measured: up to 6 months
Changes in gingival overgrowth measurements
Gingival overgrowth changes (mean scores) from baseline to 6 months.
Measured: up to 6 months
Corrosion of orthodontic devices
Percentage of areas of orthodontic devices showing corrosive superficial changes at 3 and 6 months.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jun 2017
- Primary completion10 Mar 2018 (estimated)
- Study completion10 Jul 2018 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Taubate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheila C Cortelli, PhD, Principal investigator, Dean periodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179735
- Sponsor's protocol ID
- MOUORT
- Acronym
- MOUORT
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mouthwashes as Positive Modulators of Periodontal Response During Orthodontic Treatment: a 6-month Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03179735
- Acronym / sponsor ID
- MOUORT / MOUORT
- Conditions
- Gingivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TaubateUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 10 Mar 2018 (estimated)
- Study completion
- 10 Jul 2018 (estimated)
- First posted
- 7 Jun 2017 (actual)
- 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 number of orthodontic treatment provided to Brazilian population has been increased. Unfortunately, some negative effects such as gum bleeding and bad breath are commonly observed. It partially happens because tooth brushing and flossing become more difficult in the presence of braces. Therefore, there is a need for clinical protocols able to maintain the mouth healthy during orthodontic treatment.
Considering that proper use of mouthwashes by in individuals without braces is accompanied by decrease in plaque and gum inflammation levels, it was hypothesized that, during orthodontic treatment their anti-gingivitis and anti-plaque properties would positively affect oral health. Objectives: The present study will compare the effects of two commercially available mouthwashes with a placebo mouthwash in orthodontic patients wearing fixed appliances.
Whole-mouth clinical examinations will be performed in periodontally healthy patients 15 days before, at the day of bonding and also 3 and 6 months after braces bonding. Hard and soft tissues status, presence of gingivitis and amount of dental plaque will be monitored to determine mouthwashes efficacy. At these same time-points plaque samples will be collected from dental sites and braces surfaces aiming at determining total levels of bacteria and levels of specific bacteria related to gum disease. After a full-mouth ultrasonic debridement to remove dental plaque, stains and tartar, patients will be randomly assigned to an Essential oils, Cetylpyridinium chloride or a placebo mouthwash for 6 months (40 ml/day). Further, samples of orthodontic wires will be analyzed under microscopy to check whether regular use of mouthwashes increases the risk of corrosion or not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Essential oils mouthwash | Experimental | Drug: Essential oilsEssential-oils group will rinse with an alcohol-free mouthwash (twice daily use; 20 ml/30 s) containing a fixed combination of four essential oils (eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%) |
| Cetylpyridinium mouthwash | Experimental | Drug: Cetylpyridinium Chloride 0.7 mg/mlCetylpyridinium chloride group will rinse with an alcohol-free mouthwash (twice daily use; 20 ml/30 s) containing cetylpyridinium chloride 0.7 mg/ml |
| Placebos mouthwash | Placebo comparator | Drug: PlacebosPlacebo group will rinse with an alcohol-free placebo solution (twice daily use; 20 ml/30 s) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- good general health;
- class I or class II malocclusions with a nonsurgical orthodontic treatment plan for alignment and leveling including no-extraction, extraction of two upper premolars or extraction of four premolars; no previous orthodontic treatment; overbite and overjet that allowed brackets to be placed on the lower teeth without occlusal interferences;
- periodontal health (with no clinical signals of inflammation, GI <1 e no clinical attachment loss);
- at least 26 natural teeth;
Key exclusion criteria (12 listed)
- severe skeletal malocclusion in anteroposterior, vertical or transverse dimensions; surgical orthodontic plan;
- mouth breathing;
- gingivitis; periodontitis; gingival overgrowth;
- prosthetic fixed devices, removable partial dentures or overhanging restorations;
- systemic diseases or conditions that could influence the periodontal status;
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 |
|---|---|---|
| Essential oilsPatients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home. First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding. | Drug | Essential oils mouthwash |
| Cetylpyridinium Chloride 0.7 mg/mlPatients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home. First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding. | Drug | Cetylpyridinium mouthwash |
| PlacebosPatients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home. First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding. | Drug | Placebos mouthwash |
Primary outcome
Changes in gingival index
Time frame: up to 6 months
Gingival index changes (mean scores) from baseline to 6 months.
5 secondary outcomes
Changes in plaque index
Time frame: up to 6 months
Changes in subgingival bacterial levels
Time frame: up to 6 months
Changes in bracket bacterial levels
Time frame: up to 6 months
Changes in gingival overgrowth measurements
Time frame: up to 6 months
Corrosion of orthodontic devices
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
Related trials for Gingivitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
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Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
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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.
Sheila C Cortelli, PhD principal investigator
Dean periodontics department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Essential oils and Cetylpyridinium Chloride 0.7 mg/ml in people with Gingivitis, run by University of Taubate 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 4 inclusion and 12 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 7 Jun 2017. 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. Some participants in this study may receive a placebo. 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?
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?
Changes in gingival index (time frame: up to 6 months). 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 7 Jun 2017.