Dental Implants and Mouth Rinse

Phase 2

Completed

• Conditions: Reduction in Bacterial Counts Through the Use of Mouthwash
• Interventions: Other: Mouthwash

• Registration Number: NCT02002442
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.07% Cetylpyridinium Chloride	Mouthwash	Crest Pro-Health Multi-Protection Rinse - Refreshing Clean Mint (Procter and Gamble)
Saline	Mouthwash	-
0.12% Chlorhexidine	Mouthwash	Alcohol-free Chlorhexidine Gluconate Oral Rinse USP, 0.12% from GUM®
Essential oil	Mouthwash	LISTERINE® ZERO™ Mouthwash

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Tufts University School of Dental Medicine Department of Periodontology; 🇺🇸 Boston, Massachusetts, United States