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

NCT07183163 | Completed

• 1 other identifier: E-40465587-050.01.04-432
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity &Amp; Overweight; Peri Implantitis; Dental Implant

Keywords

obesity; peri-implant health; dental implants; peri-implant sulcus fluid; inflamatory iomarkers (IL-1B, TNF-a, MMP-8)

Outcome Measures

Primary Outcomes (3)

• Levels of TNF-alfa in PICF

  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.

  Baseline

• Levels of IL-1 beta in PICF

  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.

  Baseline

• Levels of MMP-8 in PICF

  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.

  Baseline

Secondary Outcomes (1)

• Probing depth around dental implants

  Baseline

Study Arms (4)

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.

Other: Clinical and biochemical assessment

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.

Other: Clinical and biochemical assessment

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.

Other: Clinical and biochemical assessment

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.

Other: Clinical and biochemical assessment

Interventions

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.

peri-implant healthy non-obese control group,; peri-implant healthy obese group; periimplantitis non-obese group; periimplantitis obese group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of systemically healthy adults aged 18-65 years with dental implants in function for at least 1 year. Participants will be categorized into obese and non-obese groups according to BMI and waist circumference measurements.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mine Keskin: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Periodontology

Rize, 53020, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

PICF samples will be collected from implant sites using standardized paper strips. The samples will be analyzed for inflammatory biomarkers (IL-1beta, TNF-alfa, MMP-8) by ELISA. No DNA extraction will be performed.

MeSH Terms

Conditions

Obesity; Overweight; Peri-Implantitis

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Specialist in Periodontology, Recep Tayyip Erdogan University Faculty of Dentistry

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 19, 2025
• Study Start: February 12, 2023
• Primary Completion: May 27, 2024
• Study Completion: October 29, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)