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Dental Implants and Mouth Rinse

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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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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