Experimental Peri-implant Mucositis in Humans

NCT ID: NCT01941797

Last Updated: 2017-04-26

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

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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This is a pilot study. The investigators hypothesize that the peri-implant soft tissue response to de novo plaque accumulation is similar to that of normal gingival tissue in the same subjects.

The investigators propose to conduct a controlled clinical trial to evaluate peri-implant soft tissue response to de novo plaque accumulation in comparison to the response of gingival tissue in the same subjects

Detailed Description

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Conditions

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Peri-implant Mucositis Gingivitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Peri-implant mucosa

Group Type EXPERIMENTAL

interruption of oral hygiene

Intervention Type BEHAVIORAL

periodontal mucosa

Group Type ACTIVE_COMPARATOR

interruption of oral hygiene

Intervention Type BEHAVIORAL

Interventions

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interruption of oral hygiene

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

-Male and Female ³21 years of age.


* 1\) Presence of 2 implants in the maxillary or mandibular arch supporting fixed restorations in function for at least 1 year (Test)
* 2\) Presence of 2 teeth in the corresponding position of the implant (Control); -3) Absence of active infections at both test and control sites
* 4\) Absence of radiographic bone loss at both test and control sites
* 5\) Pocket depth ≤4mm at both test and control sites
* 6\) must give written informed consent.

Exclusion Criteria

* 1\) Treatment with antibiotics for any dental or medical condition within 1 month before screening
* 2\) Systemic diseases that require chronic use of anti-inflammatory medications, antibiotics or anticoagulants
* 3\) Ongoing medications for systemic conditions initiated \<3 months before the start of the study or the requirement to take prophylactic antibiotics for invasive dental procedures
* 4\) Significant organ disease including impaired kidney function, heart murmur, rheumatic fever, bleeding disorder
* 5\) Active infectious diseases such as hepatitis, tuberculosis and HIV
* 6\) Clinically detectable caries and periodontal disease
* 7\) Tobacco use of any kind
* 8\) Use of medications affecting periodontal status (diphenylhydantoin, cyclosporine etc.)
* 9\) No pregnancy or lactation or expectation to become pregnant within next 3 months.


Acute use of acetaminophen will be permitted.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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cro-2011perio-02-fp

Identifier Type: -

Identifier Source: org_study_id

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