Dental Implants and Mouth Rinse

December 3, 2018 updated by: Tufts University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Dental Medicine Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Saline
  • 0.12% Chlorhexidine
  • Essential oil
  • 0.07% Cetylpyridinium Chloride
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:
  • Saline
  • 0.12% Chlorhexidine
  • Essential oil
  • 0.07% Cetylpyridinium Chloride
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:
  • Saline
  • 0.12% Chlorhexidine
  • Essential oil
  • 0.07% Cetylpyridinium Chloride
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:
  • Saline
  • 0.12% Chlorhexidine
  • Essential oil
  • 0.07% Cetylpyridinium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
60 seconds rinse

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 seconds rinse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion

June 1, 2016

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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