Dental Implants and Mouth Rinse

NCT ID: NCT02002442

Last Updated: 2018-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Reduction in Bacterial Counts Through the Use of Mouthwash

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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0.12% Chlorhexidine

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

Group Type ACTIVE_COMPARATOR

Mouthwash

Intervention Type 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.

Essential oil

LISTERINE® ZERO™ Mouthwash

Group Type ACTIVE_COMPARATOR

Mouthwash

Intervention Type 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.

0.07% Cetylpyridinium Chloride

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

Group Type ACTIVE_COMPARATOR

Mouthwash

Intervention Type 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.

Saline

Group Type PLACEBO_COMPARATOR

Mouthwash

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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0.12% Chlorhexidine Essential oil 0.07% Cetylpyridinium Chloride Saline

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tufts University School of Dental Medicine Department of Periodontology

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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10951

Identifier Type: -

Identifier Source: org_study_id

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