Gingivitis, Peri-implant Mucositis
Conditions
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
Interventions
BEHAVIORALinterruption of oral hygiene
Sponsors
Colgate Palmolive
UConn Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed