Obesity &Amp; OverweightROPIPHNCT07183163
The Role of Obesity in Peri-Implant Health(ROPIPH)
An observational study of Obesity &Amp; Overweight and Peri Implantitis, run by Mine Keskin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity &Amp; Overweight, Peri Implantitis, Dental Implant
- What is being tested?
- Clinical and biochemical assessment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2023to 29 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Periodontology
Rize, 53020
About this study
Official title: Evaluating the Influence of Obesity on Peri-Implant Health Through Clinical and Biochemical Parameters
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.
Read the detailed 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.
- Conditions
- Obesity &Amp; Overweight, Peri Implantitis, Dental Implant
- Being tested
- Clinical and biochemical assessment
- Keywords
- obesity, peri-implant health, dental implants, peri-implant sulcus fluid, inflamatory iomarkers (IL-1B, TNF-a, MMP-8)
- Medical subject headings
- Obesity, Overweight, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and biochemical assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Clinical and biochemical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
Probing depth around dental implants
Probing depth will be measured at six sites per implant using a periodontal probe. The mean value per implant will be recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start12 Feb 2023
- Primary completion27 May 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mine Keskin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mine Keskin, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183163
- Sponsor's protocol ID
- E-40465587-050.01.04-432
- Acronym
- ROPIPH
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and institutional policy constraints. Only aggregated, de-identified summary results will be reported in the publication.
Publications
Keskin M, Zihni Korkmaz M, Bostan SA, Atak M. Influence of Obesity on Peri-Implant Health: A Cross-Sectional Clinical and Biochemical Study. Diagnostics (Basel). 2026 Mar 24;16(7):965. doi: 10.3390/diagnostics16070965.
PubMed 41975678
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Influence of Obesity on Peri-Implant Health Through Clinical and Biochemical Parameters
- ClinicalTrials.gov ID
- NCT07183163
- Acronym / sponsor ID
- ROPIPH / E-40465587-050.01.04-432
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mine KeskinUniversity, hospital or other
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| peri-implant healthy non-obese control group, | – | Other: Clinical and biochemical assessmentClinically, 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. |
| periimplantitis non-obese group | – | Other: Clinical and biochemical assessmentClinically, 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. |
| peri-implant healthy obese group | – | Other: Clinical and biochemical assessmentClinically, 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. |
| periimplantitis obese group | – | Other: Clinical and biochemical assessmentClinically, 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and biochemical assessmentAssessment 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. | Other | peri-implant healthy non-obese control group,, peri-implant healthy obese group, periimplantitis non-obese group, periimplantitis obese group |
Primary outcome
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.
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.
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.
1 secondary outcome
Probing depth around dental implants
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 41975678Keskin M, Zihni Korkmaz M, Bostan SA, Atak M. Influence of Obesity on Peri-Implant Health: A Cross-Sectional Clinical and Biochemical Study. Diagnostics (Basel). 2026 Mar 24;16(7):965. doi: 10.3390/diagnostics16070965.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and institutional policy constraints. Only aggregated, de-identified summary results will be reported in the publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity &Amp; Overweight and Peri Implantitis, run by Mine Keskin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of TNF-alfa in PICF (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.