Experimental Peri-implant Mucositis in Humans

UConn Health

Status

Completed

Conditions

Peri-implant Mucositis

Gingivitis

Treatments

Behavioral: interruption of oral hygiene

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01941797

cro-2011perio-02-fp

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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)
1. Presence of 2 teeth in the corresponding position of the implant (Control); -3) Absence of active infections at both test and control sites
1. Absence of radiographic bone loss at both test and control sites
1. Pocket depth ≤4mm at both test and control sites
1. must give written informed consent.

Exclusion criteria

1. Treatment with antibiotics for any dental or medical condition within 1 month before screening
1. Systemic diseases that require chronic use of anti-inflammatory medications, antibiotics or anticoagulants
1. 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
1. Significant organ disease including impaired kidney function, heart murmur, rheumatic fever, bleeding disorder
1. Active infectious diseases such as hepatitis, tuberculosis and HIV
1. Clinically detectable caries and periodontal disease
1. Tobacco use of any kind
1. Use of medications affecting periodontal status (diphenylhydantoin, cyclosporine etc.)
1. 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.