GingivitisNCT02709785
SmartMouth Advanced Clinical Formula Clinical Research Design Protocol
A study testing SmartMouth Clinical DDS mouthrinse and 0.12% chlorhexidine rinse in people with Gingivitis and Periodontitis, run by St. Louis University at 2 sites in United States.
Trial summary
The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse and a placebo mouthrinse. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gingivitis, Periodontitis
- What is being tested?
- SmartMouth Clinical DDS mouthrinse and 0.12% chlorhexidine rinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2016to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between the ages of 18 to 80
- Subjects with a diagnosis of gingivitis or chronic periodontitis
- Entry levels of gingival inflammation and plaque accumulation will be present (mean Gingival Index ≥ 0.4 and Plaque Index ≥ 1.0)
- Subjects that are in good medical health at time of the study
- At least 20 permanent natural teeth
Who cannot join
- Use of local or systemic antibiotics during the course of the study
- Subjects that are pregnant or nursing mothers
- Subjects undergoing orthodontic therapy
- Subjects wearing removable prostheses
- Subjects taking medication which is altering the gingiva or causing inflammation
- Gingival overgrowth
Show all 10Show fewer
- History of sensitivity or suspected allergies following the use of oral hygiene products
- Subjects taking anti-inflammatory or anticoagulant medications that would alter the gingiva and promote bleeding
- Subjects that require antibiotic prophylaxis prior to dental treatment
- Subjects that have acute dental problems requiring immediate treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southern Illinois University School of Dental Medicine
Alton, Illinois, 62002
Saint Louis University Center for Advanced Dental Education
St Louis, Missouri, 63104
About this study
The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste perception, malodor and calculus.
Read the detailed description
Study Population A 10 week double-blinded, randomized clinical study will be conducted on 80 subjects diagnosed with plaque induced gingivitis and/or chronic periodontitis. The study will take place at Saint Louis University Center for Advanced Dental Education and Southern Illinois University School of Dental Medicine.
Research Design and Methods Visit 1 Subjects who sign the informed consent and medical history forms and meet the preliminary entrance criteria will be examined at baseline. All participants will be informed of the nature of the study, its purpose, and any possible risks. Subjects will also be informed as to the length of the study and the specific procedures that will be carried out. Subjects will be informed that this is a voluntary study and that they are free to withdraw from the study at any time.
Clinical measurements of plaque and gingival indices will be taken. A gingival bleeding score will be determined. Examiners will be standardized for scoring.
Gingival index (GI) will be measured using the Loe and Silness method (Loe and Silness 1963). The gingiva will be scored at six sites of each tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual) and given a score from 0 - 3. By adding the scores and dividing by the total number of sites, the GI for the patient will be obtained. The following criteria will be used for scoring:
0 - Absence of inflammation
- - Mild inflammation: slight change in color, slight edema; no bleeding upon probing
- - Moderate inflammation: Redness, edema, and glazing; bleeding upon probing
- - Severe inflammation: Marked redness and edema; ulceration; tendency to spontaneous bleeding Sites with GI scores of 2 or 3 will be counted as bleeding. A whole mouth total gingival bleeding score will be calculated by summing the number of bleeding sites and dividing by the number of teeth.
Plaque will be scored based on the Turesky modification of the Quigley-Hein Plaque Index (PI) (Turesky 1970). A score of 0 - 5 will be assigned to six sites of each tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual) following the use of a disclosing solution. The following criteria will be used:
0 - No plaque
- - Isolated areas of plaque at gingival margin
- - Thin continuous band of plaque at gingival margin (up to 1 mm)
- - Band of plaque ˃ 1 mm and ˂ 1/3 of the tooth surface
- - Plaque covering 1/3 to ˂ 2/3 of tooth surface
- - Plaque covering ≥ 2/3 of tooth surface The Plaque Index for the entire mouth will be determined by dividing the total score by the number of surfaces examined.
The Gingival Index will be measured prior to the Plaque Index. Teeth with gross caries and third molars will not be scored with either index.
Extrinsic tooth stain will be scored on the facial surfaces of the 8 incisor teeth using a modification of the Lobene tooth stain index (SI) (Lobene 1968). Each incisor will be scored for stain area on a scale of 0-3. The sum of the stain scores for the subject will be used as that subject's stain score. Scores will be recorded from 0 to 3 as follows:
0: no stain detected, only tooth color
- stain over 1/3 of the surface
- stain over 2/3 of the surface
- stain over more than 2/3 of the surface Supragingival calculus on the lingual surfaces of the six mandibular anterior teeth will be scored using the Volpe-Manhold calculus index (CI) (Volpe et al. 1965). The supragingival calculus in three defined planes on the lingual surface of each tooth will be measured using a periodontal probe. The measurements will be added and a mean subject score will be calculated.
A complete periodontal examination will be performed for all subjects that meet the inclusion criteria. A panoramic radiograph will be taken for all subjects that do not have full mouth radiographs within the last year.
Safety assessments will be made at each measurement visit. Assessment of the oral soft tissues will be conducted at each visit by visual examination of the oral cavity. All areas will be assessed and reported as normal or abnormal.
Subject compensation: all subjects entered into the study will be given a gift card at the end of visit 2, visit 3 and visit 4.
Visit 2 Visit 2 will occur within 4 weeks of Visit 1. Subjects entered into the study will be randomly assigned to three groups: Group 1 (Smart Mouth ACF), Group 2 (0.12% chlorhexidine) or Group 3 (placebo). All subjects will be given a complete dental prophylaxis to remove plaque, calculus, and stain. Written and verbal oral hygiene instructions will be given that include a regular regimen of brushing twice daily and flossing daily. All subjects will be assigned a commercially available ADA accepted toothbrush and dental floss. They will be given a 3 week supply of the assigned mouthrinse with written and verbal instructions for use. Subjects will be instructed not to have their teeth professionally cleaned prior to study completion.
All mouthrinses will be in a plain package and dispensed by the faculty investigators. The package will be labeled with a code to indicate the product. Only the faculty investigators will have access to the code information. Directions for use will be contained in the package. The examiners will not see the product. The examiners will give instructions for mouthrinse use, but they will not be aware which rinse the subjects are using. Each product will contain two solutions which are mixed prior to use.
Visit 3 Subjects will be examined 3 weeks after visit 2. All clinical measurements will be repeated. Each subject will return with any unused rinse or two empty bottles of rinse. Compliance will be determined by regulating the amount of rinse dispensed on a 3 week basis and by the measurement of any unused rinse at the end of two 3 week periods. Additional rinse will be given to each subject after visit 3 for use until the final visit.
Visit 4 Subjects will be examined 3 weeks after visit 3 (6 weeks from visit 2). Clinical measurements will be repeated. Each subject will return with any unused rinse or two empty bottles of rinse. Compliance will be determined by the measurement of any unused rinse at the end of the study.
Subjects will be given a survey to answer questions about their experience with the mouthrinse. Prophylaxis may be performed at this visit.
Following the study, the subjects will be treated by their provider's discretion.
- Conditions
- Gingivitis, Periodontitis
- Being tested
- SmartMouth Clinical DDS mouthrinse, 0.12% chlorhexidine rinse, Placebo rinse
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartMouth Clinical DDS mouthrinseDrug
Subjects use SmartMouth Clinical DDS mouth rinse for six weeks.
0.12% chlorhexidine rinseDrug
Subjects use chlorhexidine mouth rinse for six weeks.
Placebo rinseDrug
Subjects use placebo mouth rinse for six weeks. The placebo rinse is the same as SmartMouth Clinical DDS, but without the active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 SmartMouth | Experimental | 24 subjects with plaque and gingival inflammation Receives: Drug: SmartMouth Clinical DDS mouthrinse |
| Group 2 Chlorhexidine | Experimental | 28 subjects with plaque and gingival inflammation Receives: Drug: 0.12% chlorhexidine rinse |
| Group 3 Placebo | Placebo comparator | 28 subjects with plaque and gingival inflammation Receives: Drug: Placebo rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index
Gingival Index scores gingival inflammation from 0 (healthy) to 3 (severe inflammation). The higher the score, the greater the gingival inflammation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
Measured: 6 weeks
Secondary outcomes (4)
Calculus Index
Calculus Index scores the amount of calculus accumulation by adding surfaces from the lingual of the mandibular anterior teeth. The higher the score, the worse the calculus accumulation. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
Measured: 6 weeks
Tooth Stain Index
Tooth Stain Index scores the amount of tooth stain from 0 (no stain) to 3 (greater than 2/3 of surface). The higher the score, the worse the staining. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used. The score (0-3) for each tooth are summed for the total score. The 8 incisor teeth are scored. The minimum score for a subject is "0" and the maximum score for a subject is "24" (worse outcome).
Measured: 6 weeks
Plaque Index
Plaque Index scores plaque accumulation from 0 (no plaque) to 5 (plaque covering 2/3 of surface or more). The higher the score, the more plaque accumulation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
Measured: 6 weeks
Bleeding Score
Bleeding Score is determined by adding the number of bleeding sites and dividing by the number of teeth to assess gingival inflammation. The higher the score, the worse the inflammation. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- Triumph Pharmaceuticals
- Responsible party
- Principal investigator, D. Douglas Miley, D.M.D., M.S.D, St. Louis University
- Investigators
- David D Miley, DMD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709785
- Sponsor's protocol ID
- 25867
- Status last verified
- Nov 2018
- First submitted
- 9 Mar 2016
- Last updated
- 4 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartMouth Advanced Clinical Formula Clinical Research Design Protocol
- ClinicalTrials.gov ID
- NCT02709785
- Acronym / sponsor ID
- 25867
- Conditions
- Gingivitis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- Triumph Pharmaceuticals
- Study start
- Mar 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Posted 4 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste perception, malodor and calculus.
Detailed description
Study Population A 10 week double-blinded, randomized clinical study will be conducted on 80 subjects diagnosed with plaque induced gingivitis and/or chronic periodontitis. The study will take place at Saint Louis University Center for Advanced Dental Education and Southern Illinois University School of Dental Medicine.
Research Design and Methods Visit 1 Subjects who sign the informed consent and medical history forms and meet the preliminary entrance criteria will be examined at baseline. All participants will be informed of the nature of the study, its purpose, and any possible risks. Subjects will also be informed as to the length of the study and the specific procedures that will be carried out. Subjects will be informed that this is a voluntary study and that they are free to withdraw from the study at any time.
Clinical measurements of plaque and gingival indices will be taken. A gingival bleeding score will be determined. Examiners will be standardized for scoring.
Gingival index (GI) will be measured using the Loe and Silness method (Loe and Silness 1963). The gingiva will be scored at six sites of each tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual) and given a score from 0 - 3. By adding the scores and dividing by the total number of sites, the GI for the patient will be obtained. The following criteria will be used for scoring:
0 - Absence of inflammation
- - Mild inflammation: slight change in color, slight edema; no bleeding upon probing
- - Moderate inflammation: Redness, edema, and glazing; bleeding upon probing
- - Severe inflammation: Marked redness and edema; ulceration; tendency to spontaneous bleeding Sites with GI scores of 2 or 3 will be counted as bleeding. A whole mouth total gingival bleeding score will be calculated by summing the number of bleeding sites and dividing by the number of teeth.
Plaque will be scored based on the Turesky modification of the Quigley-Hein Plaque Index (PI) (Turesky 1970). A score of 0 - 5 will be assigned to six sites of each tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual) following the use of a disclosing solution. The following criteria will be used:
0 - No plaque
- - Isolated areas of plaque at gingival margin
- - Thin continuous band of plaque at gingival margin (up to 1 mm)
- - Band of plaque ˃ 1 mm and ˂ 1/3 of the tooth surface
- - Plaque covering 1/3 to ˂ 2/3 of tooth surface
- - Plaque covering ≥ 2/3 of tooth surface The Plaque Index for the entire mouth will be determined by dividing the total score by the number of surfaces examined.
The Gingival Index will be measured prior to the Plaque Index. Teeth with gross caries and third molars will not be scored with either index.
Extrinsic tooth stain will be scored on the facial surfaces of the 8 incisor teeth using a modification of the Lobene tooth stain index (SI) (Lobene 1968). Each incisor will be scored for stain area on a scale of 0-3. The sum of the stain scores for the subject will be used as that subject's stain score. Scores will be recorded from 0 to 3 as follows:
0: no stain detected, only tooth color
- stain over 1/3 of the surface
- stain over 2/3 of the surface
- stain over more than 2/3 of the surface Supragingival calculus on the lingual surfaces of the six mandibular anterior teeth will be scored using the Volpe-Manhold calculus index (CI) (Volpe et al. 1965). The supragingival calculus in three defined planes on the lingual surface of each tooth will be measured using a periodontal probe. The measurements will be added and a mean subject score will be calculated.
A complete periodontal examination will be performed for all subjects that meet the inclusion criteria. A panoramic radiograph will be taken for all subjects that do not have full mouth radiographs within the last year.
Safety assessments will be made at each measurement visit. Assessment of the oral soft tissues will be conducted at each visit by visual examination of the oral cavity. All areas will be assessed and reported as normal or abnormal.
Subject compensation: all subjects entered into the study will be given a gift card at the end of visit 2, visit 3 and visit 4.
Visit 2 Visit 2 will occur within 4 weeks of Visit 1. Subjects entered into the study will be randomly assigned to three groups: Group 1 (Smart Mouth ACF), Group 2 (0.12% chlorhexidine) or Group 3 (placebo). All subjects will be given a complete dental prophylaxis to remove plaque, calculus, and stain. Written and verbal oral hygiene instructions will be given that include a regular regimen of brushing twice daily and flossing daily. All subjects will be assigned a commercially available ADA accepted toothbrush and dental floss. They will be given a 3 week supply of the assigned mouthrinse with written and verbal instructions for use. Subjects will be instructed not to have their teeth professionally cleaned prior to study completion.
All mouthrinses will be in a plain package and dispensed by the faculty investigators. The package will be labeled with a code to indicate the product. Only the faculty investigators will have access to the code information. Directions for use will be contained in the package. The examiners will not see the product. The examiners will give instructions for mouthrinse use, but they will not be aware which rinse the subjects are using. Each product will contain two solutions which are mixed prior to use.
Visit 3 Subjects will be examined 3 weeks after visit 2. All clinical measurements will be repeated. Each subject will return with any unused rinse or two empty bottles of rinse. Compliance will be determined by regulating the amount of rinse dispensed on a 3 week basis and by the measurement of any unused rinse at the end of two 3 week periods. Additional rinse will be given to each subject after visit 3 for use until the final visit.
Visit 4 Subjects will be examined 3 weeks after visit 3 (6 weeks from visit 2). Clinical measurements will be repeated. Each subject will return with any unused rinse or two empty bottles of rinse. Compliance will be determined by the measurement of any unused rinse at the end of the study.
Subjects will be given a survey to answer questions about their experience with the mouthrinse. Prophylaxis may be performed at this visit.
Following the study, the subjects will be treated by their provider's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 SmartMouth | Experimental | Drug: SmartMouth Clinical DDS mouthrinse24 subjects with plaque and gingival inflammation |
| Group 2 Chlorhexidine | Experimental | Drug: 0.12% chlorhexidine rinse28 subjects with plaque and gingival inflammation |
| Group 3 Placebo | Placebo comparator | Drug: Placebo rinse28 subjects with plaque and gingival inflammation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects between the ages of 18 to 80
- Subjects with a diagnosis of gingivitis or chronic periodontitis
- Entry levels of gingival inflammation and plaque accumulation will be present (mean Gingival Index ≥ 0.4 and Plaque Index ≥ 1.0)
- Subjects that are in good medical health at time of the study
- At least 20 permanent natural teeth
Key exclusion criteria (10 listed)
- Use of local or systemic antibiotics during the course of the study
- Subjects that are pregnant or nursing mothers
- Subjects undergoing orthodontic therapy
- Subjects wearing removable prostheses
- Subjects taking medication which is altering the gingiva or causing inflammation
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 |
|---|---|---|
| SmartMouth Clinical DDS mouthrinseSubjects use SmartMouth Clinical DDS mouth rinse for six weeks. | Drug | Group 1 SmartMouth |
| 0.12% chlorhexidine rinseSubjects use chlorhexidine mouth rinse for six weeks. | Drug | Group 2 Chlorhexidine |
| Placebo rinseSubjects use placebo mouth rinse for six weeks. The placebo rinse is the same as SmartMouth Clinical DDS, but without the active ingredients. | Drug | Group 3 Placebo |
Primary outcome
Gingival Index
Time frame: 6 weeks
Gingival Index scores gingival inflammation from 0 (healthy) to 3 (severe inflammation). The higher the score, the greater the gingival inflammation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
4 secondary outcomes
Calculus Index
Time frame: 6 weeks
Tooth Stain Index
Time frame: 6 weeks
Plaque Index
Time frame: 6 weeks
Bleeding Score
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
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
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.
David D Miley, DMD principal investigator
St. Louis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartMouth Clinical DDS mouthrinse and 0.12% chlorhexidine rinse in people with Gingivitis and Periodontitis, run by St. Louis University at 2 sites in United States.
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 10 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gingival Index (time frame: 6 weeks). 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 4 Dec 2018.