Assessment of peri-implantitis microflora and its interaction with host tissue.
M
Monica Gibson
Primary Investigator
Enrolling By Invitation
18 years - 75 years
All
Phase
N/A
414 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The study will investigate molecular markers associated with dental implant diseases like peri-implantitis to elucidate the mechanistic pathway involved.
• The primary goal of this study is to use GCF or PICF to analyze the microflora present around implants in disease condition and compare it to healthy samples.
• The secondary objective will be to compare oxylipin from GCF or PICF for immune markers and lipid metabolite markers between those of implant diseases and healthy samples.
• A tertiary objective will be to study the rate of healing for each of these dental wounds based on the molecular markers in primary and secondary objectives.
• The primary goal of this study is to use GCF or PICF to analyze the microflora present around implants in disease condition and compare it to healthy samples.
• The secondary objective will be to compare oxylipin from GCF or PICF for immune markers and lipid metabolite markers between those of implant diseases and healthy samples.
• A tertiary objective will be to study the rate of healing for each of these dental wounds based on the molecular markers in primary and secondary objectives.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients who have good gingival health around implants, periimplant mucositis and periimplantitis, who are scheduled for a visit to the Graduate Periodontal Clinic at IUSD and who have an existing implant will be approached by a study team member to determine interest and qualification for participation in the study. Those expressing inerest will be consented prior to the initiation of any study procedures.
Detailed description of study
What will happen during the study?
The study will have a single visit that will take place alongside the patient's regularly scheduled dental clinic visit and the following activities will take place:
• Baseline demographics, medical history, and current medications will be recorded
• Periodontal and peri-implant diagnosis will be confirmed using the patient’s periodontal chart and radiographs (Orthopantomograph (OPG) supplemented by intraoral periapical or bitewings) taken within 6 months of recruitment.
• Baseline demographics, medical history, and current medications will be recorded
• Periodontal and peri-implant diagnosis will be confirmed using the patient’s periodontal chart and radiographs (Orthopantomograph (OPG) supplemented by intraoral periapical or bitewings) taken within 6 months of recruitment.
Sample Collection - After isolation by cotton rolls, GCF/PICF samples will be collected at an upcoming regularly scheduled visit after the assessment of clinical parameters visit to avoid the contamination of the GCF/PICF with blood expressed by probing of the inflamed sites. The samples may be collected on the same day as the assessment, if bleeding can be controlled and will not affect sample collection.
In the case of periodontitis or peri-implantitis, samples will be collected from the site with the deepest probing depth. If two sites showed a similar probing depth, then the site presenting the highest CAL and signs of inflammation, along with radiographic confirmation of bone loss will be selected for the sampling. 1 µL of GCF/PICF will be collected using a PerioPaper strip. GCF/PICF samples contaminated with blood or the sites that did not express any GCF/PICF will be omitted from the study. The collected GCF will instantly be transferred to microcentrifuge tubes for further analysis.
In the case of periodontitis or peri-implantitis, samples will be collected from the site with the deepest probing depth. If two sites showed a similar probing depth, then the site presenting the highest CAL and signs of inflammation, along with radiographic confirmation of bone loss will be selected for the sampling. 1 µL of GCF/PICF will be collected using a PerioPaper strip. GCF/PICF samples contaminated with blood or the sites that did not express any GCF/PICF will be omitted from the study. The collected GCF will instantly be transferred to microcentrifuge tubes for further analysis.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Peri-implantitis, Dental Implant Disease
-
Age: 18 years - 75 years
-
Gender: All
Inclusion Criteria:
• All patients receiving treatment at Indiana University School of Dentistry Graduate Periodontics clinics and are willing to participate via signed informed consent.
• ASA Class I or II – generally healthy or medically well controlled patients.
• Age: 18 to 75 years
• Peri-implant health (Control) 8
o Absence or presence of peri-implant signs of inflammation
o Absence or presence of erythema, profuse bleeding on probing (BOP), swelling, and suppuration.
o No radiographic evidence of bone loss
• Periimplantitis (Test)
o Peri-implant signs of inflammation: erythema, swelling, fluctuant, boggy tissue.
o Profuse BOP
o Increase in Probing depths (PD)
o Radiographic evidence of bone loss.
Exclusion Criteria:
• History of local radiotherapy to head and neck region
• Pregnant or lactating
• Uncontrolled DM II (HbA1c >7% or >53mmol/mol)
• Periodontal or periimplant therapy in the last 6 months
• Used antibiotics or anti-inflammatory drugs in the last 6 months.
• Prisoners
• Unable to comply with study procedures and/or complete study visits.
• All patients receiving treatment at Indiana University School of Dentistry Graduate Periodontics clinics and are willing to participate via signed informed consent.
• ASA Class I or II – generally healthy or medically well controlled patients.
• Age: 18 to 75 years
• Peri-implant health (Control) 8
o Absence or presence of peri-implant signs of inflammation
o Absence or presence of erythema, profuse bleeding on probing (BOP), swelling, and suppuration.
o No radiographic evidence of bone loss
• Periimplantitis (Test)
o Peri-implant signs of inflammation: erythema, swelling, fluctuant, boggy tissue.
o Profuse BOP
o Increase in Probing depths (PD)
o Radiographic evidence of bone loss.
Exclusion Criteria:
• History of local radiotherapy to head and neck region
• Pregnant or lactating
• Uncontrolled DM II (HbA1c >7% or >53mmol/mol)
• Periodontal or periimplant therapy in the last 6 months
• Used antibiotics or anti-inflammatory drugs in the last 6 months.
• Prisoners
• Unable to comply with study procedures and/or complete study visits.
Updated on
17 Apr 2025.
Study ID: IUSD-IIR-MICROFLORA, 23600
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