Reduction in Bacterial Counts Through the Use of MouthwashPhase 2NCT02002442
Dental Implants and Mouth Rinse
A Phase 2 study testing Mouthwash in people with Reduction in Bacterial Counts Through the Use of Mouthwash, run by Tufts University at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or saline solution on bacterial contamination in the buccal vestibule when used preoperatively using the real-time Polymerase Chain Reaction… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reduction in Bacterial Counts Through the Use of Mouthwash
- What is being tested?
- Mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient who is treatment planned for dental implant placement and qualifies for dental implant placement according to the standards of care in the Department of Periodontology at Tufts University School of Dental Medicine.
- Aged 18 years and above.
- Partially edentulous.
Who cannot join
- Antibiotic therapy within 2 weeks of the study.
- Active infection in the oral cavity.
- Known allergy to any of the agents used in the study.
- Self-reported pregnancy (as the surgical procedure of dental implant placement is elective and typically deferred until after the delivery).
- Fully edentulous.
- Patient with severe periodontitis (Clinical attachment loss of 5mm or more in the majority of intraoral sites).
- Regular use of mouthwashes (once/day).
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine Department of Periodontology
Boston, Massachusetts, 02111
About this study
Official title: Comparison of the Effect of the Preoperative Use of Chlorhexidine, Essential Oil, and Cetylpyridinium Chloride Mouthwashes on Bacterial Contamination During Dental Implant Placement: A Randomized Controlled Clinical Trial
The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or saline solution on bacterial contamination in the buccal vestibule when used preoperatively using the real-time Polymerase Chain Reaction (qPCR).
We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in greater reduction of bacterial counts than with essential oil-based, cetylpyridinium chloride, or saline mouthwashes.
Read more
The secondary aim of this study is to evaluate the effect of the tested mouthwashes in reducing the bacterial counts over time.
We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in a reduction of bacterial counts for longer duration than with essential oil-based, cetylpyridinium chloride, or saline mouthwashes.
- Being tested
- Mouthwash
- Keywords
- Mouthwash, Chlorhexidine, cetylpyridinium chloride, Saline, Implants, Saliva Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MouthwashOther
Also called 0.12% Chlorhexidine, Essential oil, 0.07% Cetylpyridinium Chloride, Saline
An investigator will give the patient the assigned mouthwash based on the randomized group allocation. 30ml of the mouthwash will be given to the subject in a sterilized calibrated tube. The subject will be asked to rinse for 60 seconds. Then, the patient will spit the mouthwash.
| Study group | Role | What they receive |
|---|---|---|
| 0.12% Chlorhexidine | Active comparator | Alcohol-free Chlorhexidine Gluconate Oral Rinse USP, 0.12% from GUM® Receives: Other: Mouthwash |
| Essential oil | Active comparator | LISTERINE® ZERO™ Mouthwash Receives: Other: Mouthwash |
| 0.07% Cetylpyridinium Chloride | Active comparator | Crest Pro-Health Multi-Protection Rinse - Refreshing Clean Mint (Procter and Gamble) Receives: Other: Mouthwash |
| Saline | Placebo comparator | Not described Receives: Other: Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Rinse Comparison
The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or saline solution on bacterial contamination in the buccal vestibule when used preoperatively using the real-time Polymerase Chain Reaction (qPCR).
Measured: 60 seconds rinse
Secondary outcomes (1)
Bacterial Count Reduction
The secondary aim of this study is to evaluate the effect of the tested mouthwashes in reducing the bacterial counts over time.
Measured: 60 seconds rinse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction in Bacterial Counts Through the Use of MouthwashStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002442
- Sponsor's protocol ID
- 10951
- Status last verified
- Dec 2018
- First submitted
- 29 Nov 2013
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of the Preoperative Use of Chlorhexidine, Essential Oil, and Cetylpyridinium Chloride Mouthwashes on Bacterial Contamination During Dental Implant Placement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02002442
- Acronym / sponsor ID
- 10951
- Keywords
- Mouthwash, Chlorhexidine, cetylpyridinium chloride, Saline, Implants, Saliva Collection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or saline solution on bacterial contamination in the buccal vestibule when used preoperatively using the real-time Polymerase Chain Reaction (qPCR).
We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in greater reduction of bacterial counts than with essential oil-based, cetylpyridinium chloride, or saline mouthwashes.
The secondary aim of this study is to evaluate the effect of the tested mouthwashes in reducing the bacterial counts over time.
We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in a reduction of bacterial counts for longer duration than with essential oil-based, cetylpyridinium chloride, or saline mouthwashes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.12% Chlorhexidine | Active comparator | Other: MouthwashAlcohol-free Chlorhexidine Gluconate Oral Rinse USP, 0.12% from GUM® |
| Essential oil | Active comparator | Other: MouthwashLISTERINE® ZERO™ Mouthwash |
| 0.07% Cetylpyridinium Chloride | Active comparator | Other: MouthwashCrest Pro-Health Multi-Protection Rinse - Refreshing Clean Mint (Procter and Gamble) |
| Saline | Placebo comparator | Other: Mouthwash |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient who is treatment planned for dental implant placement and qualifies for dental implant placement according to the standards of care in the Department of Periodontology at Tufts University School of Dental Medicine.
- Aged 18 years and above.
- Partially edentulous.
Key exclusion criteria (7 listed)
- Antibiotic therapy within 2 weeks of the study.
- Active infection in the oral cavity.
- Known allergy to any of the agents used in the study.
- Self-reported pregnancy (as the surgical procedure of dental implant placement is elective and typically deferred until after the delivery).
- Fully edentulous.
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 |
|---|---|---|
| MouthwashAlso: 0.12% Chlorhexidine, Essential oil, 0.07% Cetylpyridinium Chloride, SalineAn investigator will give the patient the assigned mouthwash based on the randomized group allocation. 30ml of the mouthwash will be given to the subject in a sterilized calibrated tube. The subject will be asked to rinse for 60 seconds. Then, the patient will spit the mouthwash. | Other | 0.07% Cetylpyridinium Chloride, 0.12% Chlorhexidine, Essential oil, Saline |
Primary outcome
Oral Rinse Comparison
Time frame: 60 seconds rinse
The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or saline solution on bacterial contamination in the buccal vestibule when used preoperatively using the real-time Polymerase Chain Reaction (qPCR).
1 secondary outcome
Bacterial Count Reduction
Time frame: 60 seconds rinse
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 5 Dec 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mouthwash in people with Reduction in Bacterial Counts Through the Use of Mouthwash, run by Tufts University at 1 site 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 3 inclusion and 7 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 5 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 Rinse Comparison (time frame: 60 seconds rinse). 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 5 Dec 2018.