Experimental Peri-implant Mucositis in Humans

Gingivitis Clinical Trial

Official title:

Experimental Peri-implant Mucositis in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941797
• Other study ID #: cro-2011perio-02-fp
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: April 24, 2017
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Mucositis
• Peri-implant Mucositis

Intervention

Behavioral:
• interruption of oral hygiene

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival Crevicular fluid volume collected at baseline and weekly up to 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.	9 weeks