Dental Implants and Mouth Rinse

Tufts University

Status and phase: Completed; Phase 2

Conditions: Reduction in Bacterial Counts Through the Use of Mouthwash

Treatments: Other: Mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT02002442

10951

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 4 patient groups, including a placebo group

0.12% Chlorhexidine

Active Comparator group

Description:

Alcohol-free Chlorhexidine Gluconate Oral Rinse USP, 0.12% from GUM®

Treatment:

Other: Mouthwash

Essential oil

Active Comparator group

Description:

LISTERINE® ZERO™ Mouthwash

Treatment:

Other: Mouthwash

0.07% Cetylpyridinium Chloride

Active Comparator group

Description:

Crest Pro-Health Multi-Protection Rinse - Refreshing Clean Mint (Procter and Gamble)

Treatment:

Other: Mouthwash

Saline

Placebo Comparator group

Treatment:

Other: Mouthwash