Microbial Colonization Clinical Trial
Official title:
Evaluation of the Role of Smoking in the Peri-implantitis Pathogenesis
the primary aim of this project is to evaluate the microbiological and inflammatory effect of smoking status and smoking severity on periimplantitis lesions. The secondary aim is to compare the effect of smoking on periimplantitis and periodontal microbiota and inflammation in the same individuals. There will include 96 patients, equally divided into four groups: Smokers with peri-implantitis (n=24), non-smoker individuals with peri-implantitis (n=24), smokers with healthy peri-implant tissues (n=24), non-smoker individuals with healthy peri-implant tissues (n=24). Microbiological and biochemical analyses will be performed on the samples taken.
Status | Not yet recruiting |
Enrollment | 96 |
Est. completion date | December 15, 2025 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | The inclusion criteria for study groups: - 18 years old - Body mass index (BMI) £30 kg/m - Presence of min 1 implant and 1 tooth for the implant groups - At least 1 year of implant loading for implant groups for the implant groups Exclusion criteria for study groups: - Systemic diseases such as diabetes mellitus, hepatic or renal disease, or other medical conditions or transmittable diseases (ASA score III, IV, V) - Pregnancy - Having undergone antibiotics in the previous 6 months - Periodontal treatment in the previous 6 months |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Mustafa Kemal University | Dokuz Eylul University, Gazi University, University of Bern |
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The evaluation of the abundance of Fusobacterium nucleatum | The presence and abundance of Fusobacterium nucleatum will be analysed by real-time Q-PCR in plaque samples | 2 months | |
Primary | The evaluation of the abundance of Campylobacter rectus in plaque samples | The presence and abundance of Campylobacter rectus will be analysed by real-time Q-PCR in plaque samples | 2 months | |
Primary | The evaluation of the abundance of Prevotella intermedia in plaque samples | The presence and abundance of Prevotella intermedia will be analysed by real-time Q-PCR in plaque samplse | 2 months | |
Primary | The evaluation of the abundance of Aggregatinacter actinomycetemcomitans in plaque samples | The presence and abundance of Aggregatinacter actinomycetemcomitans will be analysed by real-time Q-PCR in plaque samples | 2 months | |
Primary | The evaluation of the abundance of Porphyromonas gingivalis in plaque samples | The presence and abundance of Porphyromonas gingivalis will be analysed by real-time Q-PCR in plaque samples | 2 months | |
Primary | The evaluation of the abundance of Tannerella forsythia in plaque samples | The presence and abundance of Tannerella forsythia will be analysed by real-time Q-PCR in plaque samples | 2 months | |
Primary | The evaluation of the abundance of Treponema denticola in plaque samples | The presence and abundance of Treponema denticola will be analysed by real-time Q-PCR in plaque samples | 2 months | |
Primary | The evaluation of the abundance of Saccharibacteria (TM7) in plaque samples | The presence and abundance of Saccharibacteria (TM7) will be analyzed by real-time Q-PCR in plaque samplse | 2 months | |
Primary | The evaluation of the abundance of Streptococcus aureus in plaque samples | The presence and abundance of Streptococcus aureus will be analysed by real-time Q-PCR in plaque samples | 2 months | |
Primary | The evaluation of the abundance of Actinomyces oris in plaque samples | The presence and abundance of Actinomyces oris will be analysed by real-time Q-PCR in plaque samples | 2 months | |
Secondary | The evaluation of 8-OHdG, PARK7/DJ-1, and NADPH oxidase levels in GCF and saliva samples | The concentrations of 8-OHdG will be analysed by multiplex bead immunoassay method in GCF and saliva | 2 months | |
Secondary | The evaluation of IL-1beta, IL-17A/E, and osteoprotegerin (OPG) levels in GCF and saliva samples | The concentrations of IL-1beta, IL-17A/E, osteoprotegerin (OPG) levels will be analysed by multiplex bead immunoassay method | 2 months | |
Secondary | The evaluation of MMP-8 and MMP-3 levels in GCF and saliva samples | The concentrations of MMP-8, MMP-3 will be analysed by multiplex bead immunoassay method | 2 months | |
Secondary | The evaluation of bone morphogenic protein (BMP)-2, epidermal growth factor (EGF), and vascular endothelial growth factor (VEGF) levels in GCF and saliva samples | The concentrations of bone morphogenic protein (BMP)-2, epidermal growth factor (EGF), and vascular endothelial growth factor (VEGF) will be analysed by multiplex bead immunoassay method | 2 months |
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