The Role of Obesity in Peri-Implant Health(ROPIPH)

Mine Keskin

Status: Completed

Conditions: Obesity &Amp; Overweight; Peri Implantitis; Dental Implant

Treatments: Other: Clinical and biochemical assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07183163

E-40465587-050.01.04-432

Details and patient eligibility

About

This clinical study aims to evaluate the influence of obesity on peri-implant health. Both clinical parameters and biochemical markers in peri-implant crevicular fluid(PICF) will be assessed. The study will include patients with dental implants who are classified as obese as well as a control group of non-obese participants. Clinical outcomes such as probing depth, plaque index, bleeding on probing, and peri-implant bone levels will be recorded. In addition, PICF samples will be analyzed for inflammatory biomarkers including interleukin-1 beta(IL-1beta), tumor necrosis factor-alpha(TNF-alfa), and matrix metalloproteinase-8(MMP-8). The results of this study may help to clarify the relationship between obesity and inflammatory responses in peri-implant tissues.

Full description

This prospective clinical study investigates the role of obesity in peri-implant health by assessing both clinical and biochemical parameters. The study population will consist of systemically healthy individuals aged 18 years or older who have undergone dental implant treatment. Participants will be categorized into obese and non-obese groups according to body mass index (BMI) and waist circumference measurements. Clinical evaluations will include plaque index, bleeding on probing, probing depth, and radiographic assessment of peri-implant marginal bone loss. PICF will be collected from implant sites using standardized paper strips. The collected fluid will be analyzed for inflammatory biomarkers, including IL-1 beta, TNF-alfa, and MMP-8 using enzyme-linked immunosorbent assay (ELISA). The primary objective of the study is to determine whether obesity is associated with altered peri-implant clinical parameters and increased levels of inflammatory biomarkers. By correlating clinical and biochemical findings with obesity-related measures (BMI and waist circumference), this study aims to provide valuable insights into the potential impact of obesity on peri-implant tissue health and the risk of peri-implant diseases.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults ≥18 years with dental implants in function for at least 1 year.
• Patients diagnosed with peri-implantitis according to clinical and radiographic criteria.
• For control group: systemically healthy individuals with peri-implant health.
• Written informed consent obtained.

Exclusion criteria

• Patients with systemic diseases affecting periodontal/implant health (e.g., uncontrolled diabetes, HIV, cardiovascular disease, kidney disorders).
• Pregnant or lactating women.
• Current smokers or individuals using smokeless tobacco.
• Alcohol abuse.
• Use of antibiotics or anti-inflammatory drugs within the last 3 months.
• Patients who had received peri-implant treatment within the last 6 months.

Trial design

80 participants in 4 patient groups

peri-implant healthy non-obese control group,

Description:

Clinically, the absence of signs of inflammation, bleeding and/or suppuration on probing, and any changes in the crestal bone levels other than bone remodeling were considered as peri-implant health. The presence of bleeding and/or suppuration on probing, a probing depth of 6 mm, and the presence of bone levels observed 3 mm apical to the most coronal part of the intraosseous part of the implant were considered as peri-implantitis. Participants with a BMI\> 30 kg/m2 or waist circumference (WC): \>100 cm in men and \>90 cm in women were considered obese. According to their own statements, tobacco smokers, people who used smokeless tobacco products, those who used alcohol continuously, those who were pregnant or lactating, patients with systemic diseases such as acquired immune deficiency syndrome/HIV, kidney disorders, CVD, DM, and patients who had undergone any periodontal/periimplantitis treatment in the last 6 months were excluded from the study.

Treatment:

Other: Clinical and biochemical assessment

periimplantitis non-obese group

Description:

Clinically, the absence of signs of inflammation, bleeding and/or suppuration on probing, and any changes in the crestal bone levels other than bone remodeling were considered as peri-implant health. The presence of bleeding and/or suppuration on probing, a probing depth of 6 mm, and the presence of bone levels observed 3 mm apical to the most coronal part of the intraosseous part of the implant were considered as peri-implantitis. Participants with a BMI\> 30 kg/m2 or waist circumference (WC): \>100 cm in men and \>90 cm in women were considered obese. According to their own statements, tobacco smokers, people who used smokeless tobacco products, those who used alcohol continuously, those who were pregnant or lactating, patients with systemic diseases such as acquired immune deficiency syndrome/HIV, kidney disorders, CVD, DM, and patients who had undergone any periodontal/periimplantitis treatment in the last 6 months were excluded from the study.

Treatment:

Other: Clinical and biochemical assessment

peri-implant healthy obese group

Description:

Clinically, the absence of signs of inflammation, bleeding and/or suppuration on probing, and any changes in the crestal bone levels other than bone remodeling were considered as peri-implant health. The presence of bleeding and/or suppuration on probing, a probing depth of 6 mm, and the presence of bone levels observed 3 mm apical to the most coronal part of the intraosseous part of the implant were considered as peri-implantitis. Participants with a BMI\> 30 kg/m2 or waist circumference (WC): \>100 cm in men and \>90 cm in women were considered obese. According to their own statements, tobacco smokers, people who used smokeless tobacco products, those who used alcohol continuously, those who were pregnant or lactating, patients with systemic diseases such as acquired immune deficiency syndrome/HIV, kidney disorders, CVD, DM, and patients who had undergone any periodontal/periimplantitis treatment in the last 6 months were excluded from the study.

Treatment:

Other: Clinical and biochemical assessment

periimplantitis obese group

Description:

Clinically, the absence of signs of inflammation, bleeding and/or suppuration on probing, and any changes in the crestal bone levels other than bone remodeling were considered as peri-implant health. The presence of bleeding and/or suppuration on probing, a probing depth of 6 mm, and the presence of bone levels observed 3 mm apical to the most coronal part of the intraosseous part of the implant were considered as peri-implantitis. Participants with a BMI\> 30 kg/m2 or waist circumference (WC): \>100 cm in men and \>90 cm in women were considered obese. According to their own statements, tobacco smokers, people who used smokeless tobacco products, those who used alcohol continuously, those who were pregnant or lactating, patients with systemic diseases such as acquired immune deficiency syndrome/HIV, kidney disorders, CVD, DM, and patients who had undergone any periodontal/periimplantitis treatment in the last 6 months were excluded from the study.

Treatment:

Other: Clinical and biochemical assessment