Dental Implants and Mouth Rinse

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT02002442

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Nov 1, 2013

Actual Primary Completion Date :

Jun 1, 2016

Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

Primary Outcome Measures

Oral Rinse Comparison [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

Bacterial Count Reduction [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

Criteria

Ages Eligible for Study:

18 Years and Older

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).