Completed

NCT Number: NCT02002442

Dental Implants and Mouth 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).

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.

Completed

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Key information

Conditions

Reduction in Bacterial Counts Through the Use of Mouthwash

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tufts University School of Dental Medicine Department of Periodontology

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

mouthwash

Other

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

Primary outcomes

Oral Rinse Comparison

Time frame: 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 outcomes

Bacterial Count Reduction

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study 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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Dec 5, 2013
Registry last updated: Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.