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Experimental Peri-implant Mucositis in Humans

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ClinicalTrials.gov Identifier: NCT01941797
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
UConn Health

September 10, 2013
September 13, 2013
April 26, 2017
September 2012
September 2014   (Final data collection date for primary outcome measure)
Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks [ Time Frame: 9 weeks ]
The gingival crevicular fluid ( GCF) volume is assessed using Periotron unit. The GCF volume is strongly correlated with peri-implant mucosa and gingival inflammation.
Same as current
Complete list of historical versions of study NCT01941797 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Experimental Peri-implant Mucositis in Humans
Experimental Peri-implant Mucositis in Humans

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

Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Peri-implant Mucositis
  • Gingivitis
Behavioral: interruption of oral hygiene
  • Experimental: Peri-implant mucosa
    Intervention: Behavioral: interruption of oral hygiene
  • Active Comparator: periodontal mucosa
    Intervention: Behavioral: interruption of oral hygiene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
15
September 2014
September 2014   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01941797
cro-2011perio-02-fp
No
Not Provided
Not Provided
UConn Health
UConn Health
Colgate Palmolive
Not Provided
UConn Health
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP