Experimental Peri-implant Mucositis in Humans

Not Applicable

Completed

• Conditions: Peri-implant Mucositis; Gingivitis
• Interventions: Behavioral: interruption of oral hygiene

• Registration Number: NCT01941797
• Lead Sponsor: UConn Health

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
periodontal mucosa	interruption of oral hygiene	-
Peri-implant mucosa	interruption of oral hygiene	-

Primary Outcome Measures

Name	Time	Method
Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks	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.

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States