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Experimental Peri-implant Mucositis in Humans

This study has been completed.
Colgate Palmolive
Information provided by (Responsible Party):
UConn Health Identifier:
First received: September 10, 2013
Last updated: April 24, 2017
Last verified: April 2017

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: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Experimental Peri-implant Mucositis in Humans

Further study details as provided by UConn Health:

Primary Outcome Measures:
  • 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.

Enrollment: 18
Study Start Date: September 2012
Study Completion Date: September 2014
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


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01941797

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Colgate Palmolive
  More Information

Responsible Party: UConn Health Identifier: NCT01941797     History of Changes
Other Study ID Numbers: cro-2011perio-02-fp
Study First Received: September 10, 2013
Last Updated: April 24, 2017

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases processed this record on August 18, 2017