Dental Implants and Mouth Rinse

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Reduction in Bacterial Counts Through the Use of Mouthwash

Intervention / Treatment
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* Other: Mouthwash


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.12% Chlorhexidine<br>Alcohol-free Chlorhexidine Gluconate Oral Rinse USP, 0.12% from GUM® | Other: Mouthwash<br>* 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.<br>* Other names: Saline;|
| Active Comparator: Essential oil<br>LISTERINE® ZERO™ Mouthwash | Other: Mouthwash<br>* 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.<br>* Other names: Saline;|
| Active Comparator: 0.07% Cetylpyridinium Chloride<br>Crest Pro-Health Multi-Protection Rinse - Refreshing Clean Mint (Procter and Gamble) | Other: Mouthwash<br>* 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.<br>* Other names: Saline;|
| Placebo Comparator: Saline<br> | Other: Mouthwash<br>* 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.<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 60 seconds rinse | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 60 seconds rinse | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mouthwash, Chlorhexidine, cetylpyridinium chloride, Saline, Implants, Saliva Collection