Experimental Peri-implant Mucositis in Humans
This trial is active, not recruiting.
|Conditions||peri-implant mucositis, gingivitis|
|Treatment||interruption of oral hygiene|
|Sponsor||University of Connecticut Health Center|
|Collaborator||Colgate Palmolive Co.|
|Start date||September 2012|
|End date||September 2014|
|Trial size||15 participants|
|Trial identifier||NCT01941797, cro-2011perio-02-fp|
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
|Intervention model||crossover assignment|
|Primary purpose||supportive care|
Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks
time frame: 9 weeks
Male or female participants at least 21 years old.
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.
|Official title||Experimental Peri-implant Mucositis in Humans|
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