Experimental Peri-implant Mucositis in Humans

Completed · Not applicable

Conditions studied: Peri-implant Mucositis, Gingivitis

In brief

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

Key facts

Study ID

NCT01941797

Run by

UConn Health

People needed

18

Starts

2012-09-01

Expected to finish

2014-09-01

Last updated by the study team

2017-04-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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