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 |
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
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
Farmington, Connecticut 06030
(860) 679-2000
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