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

NCT ID: NCT07183163

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-12

Study Completion Date

2024-10-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity &Amp; Overweight Peri Implantitis Dental Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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peri-implant healthy non-obese control group,

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.

Clinical and biochemical assessment

Intervention Type OTHER

Assessment of peri-implant clinical parameters (probing depth, bleeding on probing, plaque index) and biochemical markers (IL-1β, TNF-α, MMP-8) in peri-implant crevicular fluid. No therapeutic or experimental intervention administered.

periimplantitis non-obese group

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.

Clinical and biochemical assessment

Intervention Type OTHER

Assessment of peri-implant clinical parameters (probing depth, bleeding on probing, plaque index) and biochemical markers (IL-1β, TNF-α, MMP-8) in peri-implant crevicular fluid. No therapeutic or experimental intervention administered.

peri-implant healthy obese group

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.

Clinical and biochemical assessment

Intervention Type OTHER

Assessment of peri-implant clinical parameters (probing depth, bleeding on probing, plaque index) and biochemical markers (IL-1β, TNF-α, MMP-8) in peri-implant crevicular fluid. No therapeutic or experimental intervention administered.

periimplantitis obese group

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.

Clinical and biochemical assessment

Intervention Type OTHER

Assessment of peri-implant clinical parameters (probing depth, bleeding on probing, plaque index) and biochemical markers (IL-1β, TNF-α, MMP-8) in peri-implant crevicular fluid. No therapeutic or experimental intervention administered.

Interventions

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Clinical and biochemical assessment

Assessment of peri-implant clinical parameters (probing depth, bleeding on probing, plaque index) and biochemical markers (IL-1β, TNF-α, MMP-8) in peri-implant crevicular fluid. No therapeutic or experimental intervention administered.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mine Keskin

OTHER

Sponsor Role lead

Responsible Party

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Mine Keskin

Principal Investigator, Specialist in Periodontology, Recep Tayyip Erdogan University Faculty of Dentistry

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Periodontology

Rize, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-40465587-050.01.04-432

Identifier Type: -

Identifier Source: org_study_id

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