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Dental Implants and Mouth Rinse

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ClinicalTrials.gov Identifier: NCT02002442
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts University

Study Description
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Brief 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 (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.


Condition or disease Intervention/treatment Phase
Reduction in Bacterial Counts Through the Use of Mouthwash Other: Mouthwash Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 0.12% Chlorhexidine
Alcohol-free Chlorhexidine Gluconate Oral Rinse USP, 0.12% from GUM®
 Other: Mouthwash
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.
Other Names:
  • 0.12% Chlorhexidine
  • Essential oil
  • 0.07% Cetylpyridinium Chloride
  • Saline
Active Comparator: Essential oil
LISTERINE® ZERO™ Mouthwash
 Other: Mouthwash
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.
Other Names:
  • 0.12% Chlorhexidine
  • Essential oil
  • 0.07% Cetylpyridinium Chloride
  • Saline
Active Comparator: 0.07% Cetylpyridinium Chloride
Crest Pro-Health Multi-Protection Rinse - Refreshing Clean Mint (Procter and Gamble)
 Other: Mouthwash
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.
Other Names:
  • 0.12% Chlorhexidine
  • Essential oil
  • 0.07% Cetylpyridinium Chloride
  • Saline
Placebo Comparator: Saline Other: Mouthwash
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.
Other Names:
  • 0.12% Chlorhexidine
  • Essential oil
  • 0.07% Cetylpyridinium Chloride
  • Saline


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Bacterial Count Reduction [ Time Frame: 60 seconds rinse ]
    The secondary aim of this study is to evaluate the effect of the tested mouthwashes in reducing the bacterial counts over time.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002442


Locations
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United States, Massachusetts
Tufts University School of Dental Medicine Department of Periodontology
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
More Information
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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT02002442    
Other Study ID Numbers: 10951
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Keywords provided by Tufts University:
Mouthwash
Chlorhexidine
cetylpyridinium chloride
 Saline
Implants
Saliva Collection
Additional relevant MeSH terms:
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Chlorhexidine
Cetylpyridinium
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants