Experimental Peri-implant Mucositis in Humans

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
Colgate Palmolive Co.
Information provided by (Responsible Party):
Gian Schincaglia, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01941797
First received: September 10, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Peri-implant Mucositis
Gingivitis
Behavioral: interruption of oral hygiene

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Experimental Peri-implant Mucositis in Humans

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    The gingival crevicular fluid ( GCF) volume is assessed using Periotron unit. The GCF volume is strongly correlated with peri-implant mucosa and gingival inflammation.


Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peri-implant mucosa Behavioral: interruption of oral hygiene
Active Comparator: periodontal mucosa Behavioral: interruption of oral hygiene

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941797

Contacts
Contact: Gian Pietro Schincaglia, DDS,PhD 860 679 2258 ext 2258 schincaglia@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Megyn L Clement, CDA    860-679-4995 ext 4995    mclement@uchc.edu   
Principal Investigator: Gian Pietro Schincaglia, DDS,PhD         
Sponsors and Collaborators
University of Connecticut Health Center
Colgate Palmolive Co.
  More Information

No publications provided

Responsible Party: Gian Schincaglia, Clinical Associate Professor, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01941797     History of Changes
Other Study ID Numbers: cro-2011perio-02-fp
Study First Received: September 10, 2013
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gingivitis
Mucositis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 20, 2014