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
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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 |
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Reduction in Bacterial Counts Through the Use of Mouthwash | Other: Mouthwash | Phase 2 |
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 |

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

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

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
United States, Massachusetts | |
Tufts University School of Dental Medicine Department of Periodontology | |
Boston, Massachusetts, United States, 02111 |
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 |
Mouthwash Chlorhexidine cetylpyridinium chloride |
Saline Implants Saliva Collection |
Chlorhexidine Cetylpyridinium Anti-Infective Agents, Local Anti-Infective Agents Disinfectants |