GingivitisPhase 1NCT03154021
Next Science Antimicrobial Mouth Rinse Study
A Phase 1 study testing Next Science OTC Oral Rinse with Essential Oils in people with Gingivitis and Dental Plaque, run by University of Florida at 2 sites in United States.
Trial summary
To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial flora and measuring gingival inflammation and bleeding. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Next Science OTC Oral Rinse with Essential Oils
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2017to 15 May 2018
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18 and 60
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form (ICF).
- Be in good general health as determined by the investigator/designee based on a review of the Medical history/update for participation in the study;
- Have at least 20 gradable teeth;
- Have 10 or more bleeding sites at Baseline
Who cannot join
- Known allergies or sensitivity to oral rinse products, especially those containing cetylpyridinium chloride (CPC), sodium hydroxide or potassium dihydrogen phosphate.
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession.
- Active treatment for periodontitis.
- Braces
- Diabetes
- Antibiotic use within three months of the Baseline, Visit 1.
Show all 13Show fewer
- Pregnancy
- Any diseases or conditions that could be expected to interfere with the subject safely completing the study.
- Continuance Criteria
- Subjects may be excluded from the study or the analysis due to:
- Use of antibiotics any time during the study;
- Use of any non-study oral hygiene products during the study;
- A non-study dental prophylaxis or other elective dentistry during the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dental Clinical Research Unit, University of Florida
Gainesville, Florida, 32610
University of Florida College of Dentistry
Gainesville, Florida, 32610
About this study
Official title: Clinical Effectiveness of Next Science Oral Rinse in Controlling Plaques and Gingival Inflammation
To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial flora and measuring gingival inflammation and bleeding.
Read the detailed description
Baseline, Visit 1:
Prior to this visit subjects will be asked not to perform any oral hygiene the morning of the visit. They will also be asked not to use medicated lozenges, breath mints, toothpicks, eat, drink (except water), smoke and/or chew gum the morning of the study visit. Subjects will be asked to read and sign an informed consent and they will be given a signed copy. Personal medical history information will be reviewed and retained as site source documentation. Demographic Information and entrance criteria will be assessed. A comprehensive oral examination will then be conducted to evaluate the oral and perioral region, including hard and soft tissues. This will include periodontal charting for pocket depths, plaque scores as well as gingival index and bleeding scores. Plaque samples will be collected from the following four sites- mesial surface of maxillary first molar on left side, distal surface of maxillary first premolar on right side, mesial surface of mandibular second molar on left side and distal surface of mandibular lateral incisor on right side. If any of these four teeth are missing, the next tooth mesial to it will be used to collect the plaque sample.
Visit 2: Dental Prophylaxis, Oral Hygiene Instruction and Product Dispensation Subjects will receive a whole-mouth dental prophylaxis by the dental hygienist. For logistical reasons, the Dental Prophylaxis visit may occur within 2 weeks of the Baseline Visit. This visit will also include instructions on oral hygiene, dispensation of tooth brush/toothpaste and the oral rinse product. The experimental oral rinse product and the placebo will be provided by the manufacturer fully coded in prepacked bottles with the code numbers. Subjects will be instructed to brush their teeth and rinse their mouth with the dispensed product twice daily (AM/PM) for 30 seconds. A sheet of paper with pre-marked dates will be provided to each subject for them to record the time of the day they rinsed and duration. Subjects will be asked not to perform any oral hygiene the morning of their next visit. They will also be asked not to use medicated lozenges, breath mints, toothpicks, eat, drink (except water), smoke and/or chew gum the morning of the next study visit.
Week 6, Visit 3:
Subjects will be asked if they have performed any oral hygiene the morning of the visit. They will also be asked if they have used medicated lozenges, breath mints, toothpicks, eaten, had anything to drink (other than water), smoked and/or chewed gum the morning of the study visit. The paper sheet with recording of their rinsing habits will be collected. An oral examination will be conducted, an assessment of plaques and gingival scores will occur with periodontal charting for pocket depths, plaque scores as well as gingival index and bleeding scores. Dental plaque samples will be collected as before from the same sites. Any untoward experiences and findings will be recorded (example- change in taste sensation, any ulcers, blisters, etc.). New paper sheet to document their daily use of oral rinse will be provided. Subjects will be asked not to perform any oral hygiene the morning of their next visit. They will also be asked not to use medicated lozenges, breath mints, toothpicks, eat, drink (except water), smoke and/or chew gum the morning of the next study visit.
Week 12, Visit 4:
Subjects will be asked if they have performed any oral hygiene the morning of the visit. They will also be asked if they have used medicated lozenges, breath mints, toothpicks, eaten, had anything to drink (other than water), smoked and/or chewed gum the morning of the study visit.
The paper sheet with recording of their rinsing habits will be collected. Full mouth periodontal charting to include plaque and bleeding scores as well as gingival index will be recorded and dental plaque samples collected as before (from the same sites). Any untoward experiences and findings will be recorded (example- change in taste sensation, any ulcers, blisters, etc.). Patients will be informed of any dental treatment needs and general comments and Adverse Events, if applicable, will be recorded. A subject accountability form will be completed and subjects will be dismissed from the study. A subject accountability form will also be completed for subjects who drop out of the study prior to its completion.
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Next Science OTC Oral Rinse with Essential Oils, OTC Oral Rinse Control
- Keywords
- Gingival Index, Plaque Index, Bleeding, Pocket Depth
- Medical subject headings
- Gingivitis, Dental Plaque, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Science OTC Oral Rinse with Essential OilsCombination product
This group will receive Next Science Oral Rinse with Essential Oils and the other half will be give OTC Oral Rinse Control
OTC Oral Rinse ControlCombination product
This group will receive OTC Oral Rinse Control
| Study group | Role | What they receive |
|---|---|---|
| Gingivitis Test | Experimental | All subjects will have oral examination, dental cleaning, plaque samples taken, given Colgate Total Toothpaste, Oral B Manual Toothbrush and Next Science Over the Counter (OTC) Oral Rinse with Essential Oils. Receives: Combination Product: Next Science OTC Oral Rinse with Essential Oils |
| Gingivitis Placebo | Placebo comparator | All subjects will have oral examination, dental cleaning, plaque samples taken, given Colgate Total Toothpaste, Oral B Manual Toothbrush and OTC Oral Rinse Control. Receives: Combination Product: OTC Oral Rinse Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Exam to see if there are any changes in pocket depths at two weeks, six weeks and twelve weeks
Complete oral exam with charting of pocket depths
Measured: Baseline, six weeks and twelve weeks.
Gingival Index to see if there are any changes in gingival index at two weeks, six weeks and twelve weeks.
Gingival Index using Loe and Silness Gingival index
Measured: Baseline, six weeks and twelve weeks.
Plaque index to see if there are any changes in plaque scores at two weeks, six weeks and twelve weeks.
Plaque index using Turesky Plaque Index
Measured: Baseline, six weeks and twelve weeks
Bleeding Scores to see if there are any changes in bleeding at two weeks, six weeks and twelve weeks.
Check for bleeding sites
Measured: Baseline, six weeks and twelve weeks.
Secondary outcomes (1)
Plaque samples to see if there is any change in samples at two weeks, six weeks, and twelve weeks.
Plaque samples will be collected from the following four sites- mesial surface of maxillary first molar on left side, distal surface of maxillary first premolar on right side, mesial surface of mandibular second molar on left side and distal surface of mandibular lateral incisor on right side. These samples will be analyzed for composition of oral microbial flora.
Measured: Baseline, six weeks and twelve weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start28 Aug 2017
- Primary completion8 Mar 2018
- Study completion15 May 2018
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.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One half of subjects will be given test product other half will be given placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Next Science LLC
- Responsible party
- Sponsor
- Investigators
- Ann Progulske-Fox, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154021
- Sponsor's protocol ID
- IRB201700505
- Other IDs
- CSP-007
- Status last verified
- Feb 2019
- First submitted
- 5 May 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Newman BA, Rosebrough CN, Tamashiro RA, Dias Ribeiro AP, Whitlock JA, Sidhu G, Aukhil I, Porral DY, Progulske-Fox A, Myntti MF, Wang GP. A randomized controlled trial to evaluate the effectiveness of a novel mouth rinse in patients with gingivitis. BMC Oral Health. 2022 Nov 2;22(1):461. doi: 10.1186/s12903-022-02518-2.
PubMed 36324127
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Next Science Oral Rinse in Controlling Plaques and Gingival Inflammation
- ClinicalTrials.gov ID
- NCT03154021
- Acronym / sponsor ID
- IRB201700505
- Conditions
- Gingivitis, Dental Plaque
- Keywords
- Gingival Index, Plaque Index, Bleeding, Pocket Depth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Next Science LLC
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 15 May 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.
To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial flora and measuring gingival inflammation and bleeding.
Detailed description
Baseline, Visit 1:
Prior to this visit subjects will be asked not to perform any oral hygiene the morning of the visit. They will also be asked not to use medicated lozenges, breath mints, toothpicks, eat, drink (except water), smoke and/or chew gum the morning of the study visit. Subjects will be asked to read and sign an informed consent and they will be given a signed copy. Personal medical history information will be reviewed and retained as site source documentation. Demographic Information and entrance criteria will be assessed. A comprehensive oral examination will then be conducted to evaluate the oral and perioral region, including hard and soft tissues. This will include periodontal charting for pocket depths, plaque scores as well as gingival index and bleeding scores. Plaque samples will be collected from the following four sites- mesial surface of maxillary first molar on left side, distal surface of maxillary first premolar on right side, mesial surface of mandibular second molar on left side and distal surface of mandibular lateral incisor on right side. If any of these four teeth are missing, the next tooth mesial to it will be used to collect the plaque sample.
Visit 2: Dental Prophylaxis, Oral Hygiene Instruction and Product Dispensation Subjects will receive a whole-mouth dental prophylaxis by the dental hygienist. For logistical reasons, the Dental Prophylaxis visit may occur within 2 weeks of the Baseline Visit. This visit will also include instructions on oral hygiene, dispensation of tooth brush/toothpaste and the oral rinse product. The experimental oral rinse product and the placebo will be provided by the manufacturer fully coded in prepacked bottles with the code numbers. Subjects will be instructed to brush their teeth and rinse their mouth with the dispensed product twice daily (AM/PM) for 30 seconds. A sheet of paper with pre-marked dates will be provided to each subject for them to record the time of the day they rinsed and duration. Subjects will be asked not to perform any oral hygiene the morning of their next visit. They will also be asked not to use medicated lozenges, breath mints, toothpicks, eat, drink (except water), smoke and/or chew gum the morning of the next study visit.
Week 6, Visit 3:
Subjects will be asked if they have performed any oral hygiene the morning of the visit. They will also be asked if they have used medicated lozenges, breath mints, toothpicks, eaten, had anything to drink (other than water), smoked and/or chewed gum the morning of the study visit. The paper sheet with recording of their rinsing habits will be collected. An oral examination will be conducted, an assessment of plaques and gingival scores will occur with periodontal charting for pocket depths, plaque scores as well as gingival index and bleeding scores. Dental plaque samples will be collected as before from the same sites. Any untoward experiences and findings will be recorded (example- change in taste sensation, any ulcers, blisters, etc.). New paper sheet to document their daily use of oral rinse will be provided. Subjects will be asked not to perform any oral hygiene the morning of their next visit. They will also be asked not to use medicated lozenges, breath mints, toothpicks, eat, drink (except water), smoke and/or chew gum the morning of the next study visit.
Week 12, Visit 4:
Subjects will be asked if they have performed any oral hygiene the morning of the visit. They will also be asked if they have used medicated lozenges, breath mints, toothpicks, eaten, had anything to drink (other than water), smoked and/or chewed gum the morning of the study visit.
The paper sheet with recording of their rinsing habits will be collected. Full mouth periodontal charting to include plaque and bleeding scores as well as gingival index will be recorded and dental plaque samples collected as before (from the same sites). Any untoward experiences and findings will be recorded (example- change in taste sensation, any ulcers, blisters, etc.). Patients will be informed of any dental treatment needs and general comments and Adverse Events, if applicable, will be recorded. A subject accountability form will be completed and subjects will be dismissed from the study. A subject accountability form will also be completed for subjects who drop out of the study prior to its completion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One half of subjects will be given test product other half will be given placebo.
| Arm | Type | Receives |
|---|---|---|
| Gingivitis Test | Experimental | Combination Product: Next Science OTC Oral Rinse with Essential OilsAll subjects will have oral examination, dental cleaning, plaque samples taken, given Colgate Total Toothpaste, Oral B Manual Toothbrush and Next Science Over the Counter (OTC) Oral Rinse with Essential Oils. |
| Gingivitis Placebo | Placebo comparator | Combination Product: OTC Oral Rinse ControlAll subjects will have oral examination, dental cleaning, plaque samples taken, given Colgate Total Toothpaste, Oral B Manual Toothbrush and OTC Oral Rinse Control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between the ages of 18 and 60
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form (ICF).
- Be in good general health as determined by the investigator/designee based on a review of the Medical history/update for participation in the study;
- Have at least 20 gradable teeth;
- Have 10 or more bleeding sites at Baseline
Key exclusion criteria (13 listed)
- Known allergies or sensitivity to oral rinse products, especially those containing cetylpyridinium chloride (CPC), sodium hydroxide or potassium dihydrogen phosphate.
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession.
- Active treatment for periodontitis.
- Braces
- Diabetes
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 |
|---|---|---|
| Next Science OTC Oral Rinse with Essential OilsThis group will receive Next Science Oral Rinse with Essential Oils and the other half will be give OTC Oral Rinse Control | Combination product | Gingivitis Test |
| OTC Oral Rinse ControlThis group will receive OTC Oral Rinse Control | Combination product | Gingivitis Placebo |
Primary outcome
Oral Exam to see if there are any changes in pocket depths at two weeks, six weeks and twelve weeks
Time frame: Baseline, six weeks and twelve weeks.
Complete oral exam with charting of pocket depths
Gingival Index to see if there are any changes in gingival index at two weeks, six weeks and twelve weeks.
Time frame: Baseline, six weeks and twelve weeks.
Gingival Index using Loe and Silness Gingival index
Plaque index to see if there are any changes in plaque scores at two weeks, six weeks and twelve weeks.
Time frame: Baseline, six weeks and twelve weeks
Plaque index using Turesky Plaque Index
Bleeding Scores to see if there are any changes in bleeding at two weeks, six weeks and twelve weeks.
Time frame: Baseline, six weeks and twelve weeks.
Check for bleeding sites
1 secondary outcome
Plaque samples to see if there is any change in samples at two weeks, six weeks, and twelve weeks.
Time frame: Baseline, six weeks and twelve weeks.
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 18 Feb 2019.
- Derived from this study: PubMed 36324127Newman BA, Rosebrough CN, Tamashiro RA, Dias Ribeiro AP, Whitlock JA, Sidhu G, Aukhil I, Porral DY, Progulske-Fox A, Myntti MF, Wang GP. A randomized controlled trial to evaluate the effectiveness of a novel mouth rinse in patients with gingivitis. BMC Oral Health. 2022 Nov 2;22(1):461. doi: 10.1186/s12903-022-02518-2.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
Not yet recruitingObservational study
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
Periodontal Health, Gingivitis
Recruiting
Alpha-Lipoic Acid as an Adjunct to Non-Surgical Periodontal Treatment in Gingivitis
Gingivitis and Periodontal Diseases
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.
Ann Progulske-Fox, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Next Science OTC Oral Rinse with Essential Oils in people with Gingivitis and Dental Plaque, run by University of Florida 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 13 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 18 Feb 2019. 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.
What does this 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.
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?
Oral Exam to see if there are any changes in pocket depths at two weeks, six weeks and twelve weeks (time frame: Baseline, six weeks and twelve weeks.). The study lists 4 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 NCT03154021, 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 18 Feb 2019.