Experimental Peri-implant Mucositis in Humans



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:21 - Any
Updated:2/7/2015
Start Date:September 2012
End Date:March 2015
Contact:Gian Pietro Schincaglia, DDS,PhD
Email:schincaglia@uchc.edu
Phone:860 679 2258

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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


Inclusion Criteria:

-Male and Female ³21 years of age.

Oral site specific inclusion criteria:

- 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.

Participants will be excluded from the study or analysis if any of the following occur
during the study: 1) Changes in the patient medical status or medications that met the
exclusion criteria; 2) Use of antimicrobial rinses; 3) Use of irrigating devices; 4)
Subject noncompliance with stent wearing during the experimental mucositis/gingivitis
phase and/or Vitamin C use; 5) Use of anti-inflammatory drugs or antibiotics; 6) allergic
history to common toothpaste or mouth rinse ingredients.

Acute use of acetaminophen will be permitted.
We found this trial at
1
site
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
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