Experimental Peri-implant Mucositis in Humans

Study Overview
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Brief Summary
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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

Official Title
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Experimental Peri-implant Mucositis in Humans

Conditions
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Peri-implant Mucositis, Gingivitis

Intervention / Treatment
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* Behavioral: interruption of oral hygiene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peri-implant mucosa<br> | Behavioral: interruption of oral hygiene<br> <br> |
| Active Comparator: periodontal mucosa<br> | Behavioral: interruption of oral hygiene<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |