Dental Implants and Mouth Rinse

Reduction in Bacterial Counts Through the Use of Mouthwash Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002442
• Other study ID #: 10951
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: December 2018
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Reduction in Bacterial Counts Through the Use of Mouthwash

Intervention

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.

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine Department of Periodontology	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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