NCT02002442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

2.6 years

First QC Date

November 29, 2013

Last Update Submit

December 3, 2018

Conditions

Reduction in Bacterial Counts Through the Use of Mouthwash

Keywords

MouthwashChlorhexidinecetylpyridinium chlorideSalineImplantsSaliva Collection

Outcome Measures

Primary Outcomes (1)

  • Oral Rinse Comparison

    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).

    60 seconds rinse

Secondary Outcomes (1)

  • Bacterial Count Reduction

    60 seconds rinse

Study Arms (4)

0.12% Chlorhexidine

ACTIVE COMPARATOR

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

Other: Mouthwash

Essential oil

ACTIVE COMPARATOR

LISTERINE® ZERO™ Mouthwash

Other: Mouthwash

0.07% Cetylpyridinium Chloride

ACTIVE COMPARATOR

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

Other: Mouthwash

Saline

PLACEBO COMPARATOR
Other: Mouthwash

Interventions

MouthwashOTHER

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.

Also known as: 0.12% Chlorhexidine, Essential oil, 0.07% Cetylpyridinium Chloride, Saline
0.07% Cetylpyridinium Chloride0.12% ChlorhexidineEssential oilSaline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University School of Dental Medicine Department of Periodontology

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

MouthwashesChlorhexidineOils, VolatileCetylpyridiniumSodium Chloride

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and AgricultureBiguanidesGuanidinesAmidinesOrganic ChemicalsOilsLipidsPyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2013

First Posted

December 5, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 5, 2018

Record last verified: 2018-12

Locations

US(1)