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NCT Number: NCT07183163

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Periodontology

Rize, 53020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical and biochemical assessment

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.

Primary outcomes

  1. Levels of TNF-alfa in PICF

    Time frame: Baseline

    TNF-alfa concentration in PICF will be quantified using ELISA. Samples will be collected from four sites per implant (mesial, distal, buccal, lingual). Higher levels indicate increased inflammation.

  2. Levels of IL-1 beta in PICF

    Time frame: Baseline

    IL-1beta concentration in PICF will be quantified using ELISA. Samples will be collected from four sites per implant (mesial, distal, buccal, lingual). Higher levels indicate increased inflammation.

  3. Levels of MMP-8 in PICF

    Time frame: Baseline

    MMP-8 concentration in PICF will be quantified using ELISA. Samples will be collected from four sites per implant (mesial, distal, buccal, lingual). Higher levels indicate increased inflammation.

Secondary outcomes

  1. Probing depth around dental implants

    Time frame: Baseline

    Probing depth will be measured at six sites per implant using a periodontal probe. The mean value per implant will be recorded.

Sponsors and collaborators

Lead sponsor

Mine Keskin

Other

Registry information

Official study title

Evaluating the Influence of Obesity on Peri-Implant Health Through Clinical and Biochemical Parameters

Acronym: ROPIPH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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