Alveolar Bone LossNCT05640284
Evaluation of the Effect of Periimplant Soft Tissue Phenotype on Marginal Bone Loss
An observational study of Alveolar Bone Loss and Dental Implant, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial to test the effect of periimplant soft tissue phenotype in the participants with implant placed and at least 1 year after implant loading. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alveolar Bone Loss, Dental Implant, Periimplantitis
- What is being tested?
- Nuclear Factor-Kappa B Ligand (RANKL) analysis, Osteoprotegerin (OPG) analysis and Tumor Necrosis Factor Alpha (TNF-α) analysis
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2022to 15 Jan 2023
- 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
- Adult, Older adult
Study population: The participants will be selected from among the patients whose implant placement was performed by the same periodontologist (E.Ö) at Necmettin Erbakan University, Department of Periodontology between 2020 and whose radiographic and clinical follow-up is still ongoing for 6 months. Of each selected study patient, those who signed the written informed consent form and met the inclusion and exclusion criteria will be included in the study. 80 implants in approximately 40 patients are planned to be included in the trial.
Who may be able to join
- Have at least one fixed restoration on a titanium dental implant in the mouth
- Over-implant restoration, functioning for at least 12 months
- Attending our preventive care regularly (≥1/year)
- Non-smokers
Who cannot join
- Receiving head or neck radiation in the last 6 months
- Bisphosphonate users
- Those who have received antibiotic treatment in the last 3 months
- Patients with diabetes mellitus (hemoglobin A1c ≥7.0) that may affect the outcome of implant therapy
- implants with peri-implantitis
- Pregnant or breastfeeding mothers
Show all 11Show fewer
- Those with metabolic bone disorders
- Those who have a history of periodontitis and have undergone any periodontal treatment in the last year
- Those whose implant positions are not suitable
- Implants using soft or hard tissue grafts before, during, or after implant placement
- Those with a restoration that did not allow accurate probing depth recording were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, dentistry Faculty
Konya
About this study
Official title: Evaluation of the Effect of Periimplant Soft Tissue Phenotype on Marginal Bone Loss Using Biochemical Approach
The goal of this clinical trial to test the effect of periimplant soft tissue phenotype in the participants with implant placed and at least 1 year after implant loading. The main questions it aims to answer are:
- Is keratinized mucosal thickness (KMT) important in early marginal bone loss and peri implant health?
- Is keratinized gingival width (KGW) important in early marginal bone loss and and peri implant health? The researchers plan to include 80 implants in the study. These 80 implants will be divided into 2 groups in 2 different ways according to their KMT and KGW on their buccal surfaces: KMT ≥2 mm are included in the adequate KMT, and those with KMT<2 mm are in the insufficient KMT group. Those with KGW≥2 mm are adequate KGW, those with KGW<2 mm are adequate KGW. The researchers will assess marginal bone loss around the implant using radiographs and collect peri-implant crevicular fluid (PICF) using paper strips. Another researchers will measure the Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL), Osteoprotegerin (OPG), Tumor Necrosis Factor Alpha (TNF-α), MicroRNA-223 (MiRNA-223), MicroRNA-27a (MiRNA-27a) levels in the collected PICF. They will compare radiographic bone loss and biomarker levels in groups.
Read the detailed description
Early marginal bone loss around the implant can be caused by various reasons. Keratinized mucosal thickness (KMT) and keratinized gingival width (KGW) are components of periimplant soft tissue. Recently, KGW and KMT in the peri-implant region have been investigated as possible factors influencing this phenomenon.
The hypothesis of this study: Periimplant soft tissue phenotype is associated with marginal bone loss and peri implant health through Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL), Osteoprotegerin (OPG), Tumor Necrosis Factor Alpha (TNF-α), MicroRNA-223 (MiRNA-223) and Microrna-27a 80 implants, at least 1 year after their loading, in patients who continued their routine controls will be included in the study. The participants in this study were selected from patients who underwent implant placement by the same periodontologist (E.Ö.) in the Department of Periodontology of Necmettin Erbakan University in 2020 and still have 6-month radiographic and clinical follow-up. Selected patients, those who signed the written informed consent form were included in the study. In the study, the first radiographs of all patients, the clinical and radiographic conditions obtained at the 6-month routine control examination will be evaluated. During the same routine controls, a sample of peri-implant groove fluid was taken with paper strips.
Diagnoses of the implants included in the study will be made using the criteria of the 2017 World Workshop on Periodontal and Peri-implant Diseases and Conditions. 2 mm marginal bone loss (MBL) which may occur during the bone remodeling process after implant placement and loading, is accepted as the threshold. The absence of signs of inflammation (redness, swelling, bleeding on probing) in the peri-implant soft tissue, probing depth (PD) ≤5 mm with mild force (approximately 0.25 N), and no further bone loss following initial healing are defined as "periimplant health". "Peri-implant mucositis" is defined as clinically observable signs of inflammation (swelling, redness and soft consistency of tissue), bleeding on probing (BOP) (lines or drops) and/or signs of suppuration in the absence of bone loss greater than 2 mm, the threshold for initial bone remodulation defined. The definition of "peri-implantitis" is clinically observable signs of inflammation, probing bleeding and/or suppuration, increased probing depth, progressive bone loss after implant restoration, or MBL ≥3 mm with profuse bleeding in the absence of initial radiographs and PD was ≥6 mm. Implants with periimplantitis will be excluded. Implants will be divided into 2 groups according to their peri-implant health: Peri-implant health and peri-implant mucositis.
In addition to routine clinical and radiographic examination of the implants, KMT and KGW measurements will be made. they will be divided into 2 groups in 2 ways. According to KMT on their buccal surfaces: KMT ≥2 mm are included in the adequate KMT, and those with KMT <2 mm are in the inadequate KMT group (60). According to KGW on their buccal surfaces: KGW≥2 mm are adequate KGW, those with KGW<2 mm are inadequate KGW.
Radiographic evaluation will be made using intraoral periapical radiographs obtained using the parallel technique with the plastic film holder. Calibration of digital images will be performed using the length of the implant as a well-defined fixed reference point. The bone level measurement will be made by measuring between the bone-implant first contact point and the reference point in the coronal part of the implant body selected for different implant systems in both the mesial and distal directions of the implants. In order to evaluate the marginal bone loss (MBL), the measurements obtained will be compared with the measurements on the radiographs taken after the delivery of the prosthesis.
Peri-implant crevicular fluid (PIGF) will be collected from the participants for the biochemical evaluation to be made. PIGF specimens will be collected from the mesiobuccal of each implant, prior to any periodontal probing, and after removal of the supra mucosal plate. The area to be sampled will be insulated with cotton rolls and air-dried. The paper will be advanced with the strip until it shows slight resistance and held in the sample area for 30 seconds. Samples will be stored at -70˚C.
TNF-α, RANKL, OPG and MiRNA 223 and MiRNA 27a evaluations of the peri-implant crevicular fluid (PIGF) collected from the patients will be performed. TNF-α, RANKL and OPG will be evaluated by the Enzyme-Linked ImmunoSorbent Assay (ELISA) method. MiRNA 223 and MiRNA 27a evaluations will be performed using Real-Time Polymerase Chain Reaction (RT-PCR).
Marginal bone loss and biomarker levels will be compared between the groups.
- Conditions
- Alveolar Bone Loss, Dental Implant, Periimplantitis
- Being tested
- Nuclear Factor-Kappa B Ligand (RANKL) analysis, Osteoprotegerin (OPG) analysis, Tumor Necrosis Factor Alpha (TNF-α) analysis, MicroRNA-223 analysis, Microrna-27a analysis
- Keywords
- periimplantitis, MicroRNA, dental implants, soft tissue phenotype, alveolar bone loss
- Medical subject headings
- Alveolar Bone Loss, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuclear Factor-Kappa B Ligand (RANKL) analysisDiagnostic test
samples of peri-implant groove fluid will be taken with paper strips and RANKL assessment will be made
Osteoprotegerin (OPG) analysisDiagnostic test
samples of peri-implant groove fluid will be taken with paper strips and OPG assessment will be made
Tumor Necrosis Factor Alpha (TNF-α) analysisDiagnostic test
samples of peri-implant groove fluid will be taken with paper strips and TNF-α assessment will be made
MicroRNA-223 analysisDiagnostic test
samples of peri-implant groove fluid will be taken with paper strips and MicroRNA-223 assessment will be made
Microrna-27a analysisDiagnostic test
samples of peri-implant groove fluid will be taken with paper strips and Microrna-27a assessment will be made
| Study group | Role | What they receive |
|---|---|---|
| Adequate KMT | Keratinized mucosal thicknesses (KMT) on their buccal surfaces are 2 mm and above. Receives: Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis; Diagnostic Test: Osteoprotegerin (OPG) analysis; Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis; Diagnostic Test: MicroRNA-223 analysis; Diagnostic Test: Microrna-27a analysis | |
| inadequate KMT | Keratinized mucosal thicknesses (KMT) on their buccal surfaces are less than 2 mm. Receives: Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis; Diagnostic Test: Osteoprotegerin (OPG) analysis; Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis; Diagnostic Test: MicroRNA-223 analysis; Diagnostic Test: Microrna-27a analysis | |
| adequate KGW | keratinized gingival width (KGW) on their buccal surfaces are 2 mm and above. Receives: Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis; Diagnostic Test: Osteoprotegerin (OPG) analysis; Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis; Diagnostic Test: MicroRNA-223 analysis; Diagnostic Test: Microrna-27a analysis | |
| inadequate KGW | keratinized gingival width (KGW) on their buccal surfaces are less than 2 mm. Receives: Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis; Diagnostic Test: Osteoprotegerin (OPG) analysis; Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis; Diagnostic Test: MicroRNA-223 analysis; Diagnostic Test: Microrna-27a analysis | |
| Peri-implant health | The absence of signs of inflammation (redness, swelling, bleeding on probing) in the peri-implant soft tissue, probing depth (PD) ≤5 mm with mild force (approximately 0.25 N), and no further bone loss following initial healing are defined as "peri-implant health". Receives: Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis; Diagnostic Test: Osteoprotegerin (OPG) analysis; Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis; Diagnostic Test: MicroRNA-223 analysis; Diagnostic Test: Microrna-27a analysis | |
| peri-implant mucositis | "Peri-implant mucositis" is defined as clinically observable signs of inflammation (swelling, redness and soft consistency of tissue), bleeding on probing (lines or drops) and/or signs of suppuration in the absence of bone loss greater than 2 mm, the threshold for initial bone remodulation. Receives: Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis; Diagnostic Test: Osteoprotegerin (OPG) analysis; Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis; Diagnostic Test: MicroRNA-223 analysis; Diagnostic Test: Microrna-27a analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL) level between peri-implant health and peri-implant mucositis groups
The RANKL levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean Osteoprotegerin (OPG) level between peri-implant health and peri-implant mucositis groups
The OPG levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean Tumor Necrosis Factor Alpha (TNF-α) level between peri-implant health and peri-implant mucositis groups
The TNF-α levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean MicroRNA-223 level between peri-implant health and peri-implant mucositis groups
The MicroRNA-223 levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean MicroRNA-27a level between peri-implant health and peri-implant mucositis groups
The MicroRNA-27a levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of alveolar bone loss between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
The bone level measurement will be made by measuring between the bone-implant first contact point and the reference point in the coronal part of the implant body selected for different implant systems in both the mesial and distal directions of the implants. In order to evaluate the marginal bone loss (MBL), the measurements obtained will be compared with the measurements on the radiographs taken after the delivery of the prosthesis.
Measured: It will be done at the start of the study, immediately after the control radiograph is taken.
Comparison of alveolar bone loss between between adequate keratinized gingival width (KGW) and inadequate KGW groups
The bone level measurement will be made by measuring between the bone-implant first contact point and the reference point in the coronal part of the implant body selected for different implant systems in both the mesial and distal directions of the implants. In order to evaluate the marginal bone loss (MBL), the measurements obtained will be compared with the measurements on the radiographs taken after the delivery of the prosthesis.
Measured: It will be done at the start of the study, immediately after the control radiograph is taken.
Comparison of mean Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL) level between adequate KMT and inadequate KMT groups
The RANKL levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL) level between adequate KGW and inadequate KGW groups
The RANKL levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean Osteoprotegerin (OPG) level between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
The OPG levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean Osteoprotegerin (OPG) level between between adequate keratinized gingival width (KGW) and inadequate KGW groups
The OPG levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean Tumor Necrosis Factor Alpha (TNF-α) level between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
The TNF-α levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean Tumor Necrosis Factor Alpha (TNF-α) level between between adequate keratinized gingival width (KGW) and inadequate KGW groups
The TNF-α levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean MicroRNA-223 level between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
The MicroRNA-223 levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean MicroRNA-223 level between between adequate keratinized gingival width (KGW) and inadequate KGW groups
The MicroRNA-223 levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean MicroRNA-27a level between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
The MicroRNA-27a levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Comparison of mean MicroRNA-27a level between between adequate keratinized gingival width (KGW) and inadequate KGW groups
The MicroRNA-27a levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Secondary outcomes (5)
Correlation between MBL amounts and TNF-α
The correlation MBL amounts and TNF-α will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Correlation between MBL amounts and RANKL
The correlation MBL amounts and RANKL will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Correlation between MBL amounts and OPG
The correlation MBL amounts and OPG will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Correlation between MBL amounts and MicroRNA-223
The correlation MBL amounts and MicroRNA-223 will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Correlation between MBL amounts and MicroRNA-27a
The correlation MBL amounts and MicroRNA-27a will be evaluated.
Measured: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start2 Dec 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Tastan Eroglu, Necmettin Erbakan University
- Investigators
- zeynep taştan eroğlu, Study director, Necmettin Erbakan Universitydilek özkan şen, Principal investigator, Necmettin Erbakan Universityelif öncü, Principal investigator, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640284
- Sponsor's protocol ID
- periimplantmicrorna
- Status last verified
- Jan 2023
- First submitted
- 25 Nov 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Periimplant Soft Tissue Phenotype on Marginal Bone Loss Using Biochemical Approach
- ClinicalTrials.gov ID
- NCT05640284
- Acronym / sponsor ID
- periimplantmicrorna
- Conditions
- Alveolar Bone Loss, Dental Implant, Periimplantitis
- Keywords
- periimplantitis, MicroRNA, dental implants, soft tissue phenotype, alveolar bone loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 7 Dec 2022 (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.
The goal of this clinical trial to test the effect of periimplant soft tissue phenotype in the participants with implant placed and at least 1 year after implant loading. The main questions it aims to answer are:
- Is keratinized mucosal thickness (KMT) important in early marginal bone loss and peri implant health?
- Is keratinized gingival width (KGW) important in early marginal bone loss and and peri implant health? The researchers plan to include 80 implants in the study. These 80 implants will be divided into 2 groups in 2 different ways according to their KMT and KGW on their buccal surfaces: KMT ≥2 mm are included in the adequate KMT, and those with KMT<2 mm are in the insufficient KMT group. Those with KGW≥2 mm are adequate KGW, those with KGW<2 mm are adequate KGW. The researchers will assess marginal bone loss around the implant using radiographs and collect peri-implant crevicular fluid (PICF) using paper strips. Another researchers will measure the Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL), Osteoprotegerin (OPG), Tumor Necrosis Factor Alpha (TNF-α), MicroRNA-223 (MiRNA-223), MicroRNA-27a (MiRNA-27a) levels in the collected PICF. They will compare radiographic bone loss and biomarker levels in groups.
Detailed description
Early marginal bone loss around the implant can be caused by various reasons. Keratinized mucosal thickness (KMT) and keratinized gingival width (KGW) are components of periimplant soft tissue. Recently, KGW and KMT in the peri-implant region have been investigated as possible factors influencing this phenomenon.
The hypothesis of this study: Periimplant soft tissue phenotype is associated with marginal bone loss and peri implant health through Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL), Osteoprotegerin (OPG), Tumor Necrosis Factor Alpha (TNF-α), MicroRNA-223 (MiRNA-223) and Microrna-27a 80 implants, at least 1 year after their loading, in patients who continued their routine controls will be included in the study. The participants in this study were selected from patients who underwent implant placement by the same periodontologist (E.Ö.) in the Department of Periodontology of Necmettin Erbakan University in 2020 and still have 6-month radiographic and clinical follow-up. Selected patients, those who signed the written informed consent form were included in the study. In the study, the first radiographs of all patients, the clinical and radiographic conditions obtained at the 6-month routine control examination will be evaluated. During the same routine controls, a sample of peri-implant groove fluid was taken with paper strips.
Diagnoses of the implants included in the study will be made using the criteria of the 2017 World Workshop on Periodontal and Peri-implant Diseases and Conditions. 2 mm marginal bone loss (MBL) which may occur during the bone remodeling process after implant placement and loading, is accepted as the threshold. The absence of signs of inflammation (redness, swelling, bleeding on probing) in the peri-implant soft tissue, probing depth (PD) ≤5 mm with mild force (approximately 0.25 N), and no further bone loss following initial healing are defined as "periimplant health". "Peri-implant mucositis" is defined as clinically observable signs of inflammation (swelling, redness and soft consistency of tissue), bleeding on probing (BOP) (lines or drops) and/or signs of suppuration in the absence of bone loss greater than 2 mm, the threshold for initial bone remodulation defined. The definition of "peri-implantitis" is clinically observable signs of inflammation, probing bleeding and/or suppuration, increased probing depth, progressive bone loss after implant restoration, or MBL ≥3 mm with profuse bleeding in the absence of initial radiographs and PD was ≥6 mm. Implants with periimplantitis will be excluded. Implants will be divided into 2 groups according to their peri-implant health: Peri-implant health and peri-implant mucositis.
In addition to routine clinical and radiographic examination of the implants, KMT and KGW measurements will be made. they will be divided into 2 groups in 2 ways. According to KMT on their buccal surfaces: KMT ≥2 mm are included in the adequate KMT, and those with KMT <2 mm are in the inadequate KMT group (60). According to KGW on their buccal surfaces: KGW≥2 mm are adequate KGW, those with KGW<2 mm are inadequate KGW.
Radiographic evaluation will be made using intraoral periapical radiographs obtained using the parallel technique with the plastic film holder. Calibration of digital images will be performed using the length of the implant as a well-defined fixed reference point. The bone level measurement will be made by measuring between the bone-implant first contact point and the reference point in the coronal part of the implant body selected for different implant systems in both the mesial and distal directions of the implants. In order to evaluate the marginal bone loss (MBL), the measurements obtained will be compared with the measurements on the radiographs taken after the delivery of the prosthesis.
Peri-implant crevicular fluid (PIGF) will be collected from the participants for the biochemical evaluation to be made. PIGF specimens will be collected from the mesiobuccal of each implant, prior to any periodontal probing, and after removal of the supra mucosal plate. The area to be sampled will be insulated with cotton rolls and air-dried. The paper will be advanced with the strip until it shows slight resistance and held in the sample area for 30 seconds. Samples will be stored at -70˚C.
TNF-α, RANKL, OPG and MiRNA 223 and MiRNA 27a evaluations of the peri-implant crevicular fluid (PIGF) collected from the patients will be performed. TNF-α, RANKL and OPG will be evaluated by the Enzyme-Linked ImmunoSorbent Assay (ELISA) method. MiRNA 223 and MiRNA 27a evaluations will be performed using Real-Time Polymerase Chain Reaction (RT-PCR).
Marginal bone loss and biomarker levels will be compared between the groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Adequate KMT | – | Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis, Diagnostic Test: Osteoprotegerin (OPG) analysis, Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis, Diagnostic Test: MicroRNA-223 analysis, Diagnostic Test: Microrna-27a analysisKeratinized mucosal thicknesses (KMT) on their buccal surfaces are 2 mm and above. |
| inadequate KMT | – | Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis, Diagnostic Test: Osteoprotegerin (OPG) analysis, Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis, Diagnostic Test: MicroRNA-223 analysis, Diagnostic Test: Microrna-27a analysisKeratinized mucosal thicknesses (KMT) on their buccal surfaces are less than 2 mm. |
| adequate KGW | – | Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis, Diagnostic Test: Osteoprotegerin (OPG) analysis, Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis, Diagnostic Test: MicroRNA-223 analysis, Diagnostic Test: Microrna-27a analysiskeratinized gingival width (KGW) on their buccal surfaces are 2 mm and above. |
| inadequate KGW | – | Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis, Diagnostic Test: Osteoprotegerin (OPG) analysis, Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis, Diagnostic Test: MicroRNA-223 analysis, Diagnostic Test: Microrna-27a analysiskeratinized gingival width (KGW) on their buccal surfaces are less than 2 mm. |
| Peri-implant health | – | Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis, Diagnostic Test: Osteoprotegerin (OPG) analysis, Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis, Diagnostic Test: MicroRNA-223 analysis, Diagnostic Test: Microrna-27a analysisThe absence of signs of inflammation (redness, swelling, bleeding on probing) in the peri-implant soft tissue, probing depth (PD) ≤5 mm with mild force (approximately 0.25 N), and no further bone loss following initial healing are defined as "peri-implant health". |
| peri-implant mucositis | – | Diagnostic Test: Nuclear Factor-Kappa B Ligand (RANKL) analysis, Diagnostic Test: Osteoprotegerin (OPG) analysis, Diagnostic Test: Tumor Necrosis Factor Alpha (TNF-α) analysis, Diagnostic Test: MicroRNA-223 analysis, Diagnostic Test: Microrna-27a analysis"Peri-implant mucositis" is defined as clinically observable signs of inflammation (swelling, redness and soft consistency of tissue), bleeding on probing (lines or drops) and/or signs of suppuration in the absence of bone loss greater than 2 mm, the threshold for initial bone remodulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participants will be selected from among the patients whose implant placement was performed by the same periodontologist (E.Ö) at Necmettin Erbakan University, Department of Periodontology between 2020 and whose radiographic and clinical follow-up is still ongoing for 6 months. Of each selected study patient, those who signed the written informed consent form and met the inclusion and exclusion criteria will be included in the study. 80 implants in approximately 40 patients are planned to be included in the trial.
Key inclusion criteria (4 listed)
- Have at least one fixed restoration on a titanium dental implant in the mouth
- Over-implant restoration, functioning for at least 12 months
- Attending our preventive care regularly (≥1/year)
- Non-smokers
Key exclusion criteria (11 listed)
- Receiving head or neck radiation in the last 6 months
- Bisphosphonate users
- Those who have received antibiotic treatment in the last 3 months
- Patients with diabetes mellitus (hemoglobin A1c ≥7.0) that may affect the outcome of implant therapy
- implants with peri-implantitis
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 |
|---|---|---|
| Nuclear Factor-Kappa B Ligand (RANKL) analysissamples of peri-implant groove fluid will be taken with paper strips and RANKL assessment will be made | Diagnostic test | Adequate KMT, Peri-implant health, adequate KGW, inadequate KGW, inadequate KMT, peri-implant mucositis |
| Osteoprotegerin (OPG) analysissamples of peri-implant groove fluid will be taken with paper strips and OPG assessment will be made | Diagnostic test | Adequate KMT, Peri-implant health, adequate KGW, inadequate KGW, inadequate KMT, peri-implant mucositis |
| Tumor Necrosis Factor Alpha (TNF-α) analysissamples of peri-implant groove fluid will be taken with paper strips and TNF-α assessment will be made | Diagnostic test | Adequate KMT, Peri-implant health, adequate KGW, inadequate KGW, inadequate KMT, peri-implant mucositis |
| MicroRNA-223 analysissamples of peri-implant groove fluid will be taken with paper strips and MicroRNA-223 assessment will be made | Diagnostic test | Adequate KMT, Peri-implant health, adequate KGW, inadequate KGW, inadequate KMT, peri-implant mucositis |
| Microrna-27a analysissamples of peri-implant groove fluid will be taken with paper strips and Microrna-27a assessment will be made | Diagnostic test | Adequate KMT, Peri-implant health, adequate KGW, inadequate KGW, inadequate KMT, peri-implant mucositis |
Primary outcome
Comparison of mean Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL) level between peri-implant health and peri-implant mucositis groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The RANKL levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean Osteoprotegerin (OPG) level between peri-implant health and peri-implant mucositis groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The OPG levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean Tumor Necrosis Factor Alpha (TNF-α) level between peri-implant health and peri-implant mucositis groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The TNF-α levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean MicroRNA-223 level between peri-implant health and peri-implant mucositis groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The MicroRNA-223 levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Comparison of mean MicroRNA-27a level between peri-implant health and peri-implant mucositis groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The MicroRNA-27a levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Comparison of alveolar bone loss between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
Time frame: It will be done at the start of the study, immediately after the control radiograph is taken.
The bone level measurement will be made by measuring between the bone-implant first contact point and the reference point in the coronal part of the implant body selected for different implant systems in both the mesial and distal directions of the implants. In order to evaluate the marginal bone loss (MBL), the measurements obtained will be compared with the measurements on the radiographs taken after the delivery of the prosthesis.
Comparison of alveolar bone loss between between adequate keratinized gingival width (KGW) and inadequate KGW groups
Time frame: It will be done at the start of the study, immediately after the control radiograph is taken.
The bone level measurement will be made by measuring between the bone-implant first contact point and the reference point in the coronal part of the implant body selected for different implant systems in both the mesial and distal directions of the implants. In order to evaluate the marginal bone loss (MBL), the measurements obtained will be compared with the measurements on the radiographs taken after the delivery of the prosthesis.
Comparison of mean Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL) level between adequate KMT and inadequate KMT groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The RANKL levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL) level between adequate KGW and inadequate KGW groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The RANKL levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean Osteoprotegerin (OPG) level between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The OPG levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean Osteoprotegerin (OPG) level between between adequate keratinized gingival width (KGW) and inadequate KGW groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The OPG levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean Tumor Necrosis Factor Alpha (TNF-α) level between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The TNF-α levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean Tumor Necrosis Factor Alpha (TNF-α) level between between adequate keratinized gingival width (KGW) and inadequate KGW groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The TNF-α levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via Enzyme-Linked ImmunoSorbent Assay . The difference between the groups will be evaluated.
Comparison of mean MicroRNA-223 level between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The MicroRNA-223 levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Comparison of mean MicroRNA-223 level between between adequate keratinized gingival width (KGW) and inadequate KGW groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The MicroRNA-223 levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Comparison of mean MicroRNA-27a level between adequate Keratinized mucosal thickness (KMT) and inadequate KMT groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The MicroRNA-27a levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
Comparison of mean MicroRNA-27a level between between adequate keratinized gingival width (KGW) and inadequate KGW groups
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
The MicroRNA-27a levels in the peri-implant crevicular fluid (PIGF) collected from the patients will be measured via real-time polymerase chain reaction. The difference between the groups will be evaluated.
5 secondary outcomes
Correlation between MBL amounts and TNF-α
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Correlation between MBL amounts and RANKL
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Correlation between MBL amounts and OPG
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Correlation between MBL amounts and MicroRNA-223
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Correlation between MBL amounts and MicroRNA-27a
Time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.
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 25 Jan 2023.
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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.
zeynep taştan eroğlu study director
Necmettin Erbakan University
dilek özkan şen principal investigator
Necmettin Erbakan University
elif öncü principal investigator
Lokman Hekim University
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 Alveolar Bone Loss and Dental Implant, run by Necmettin Erbakan University 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 11 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 25 Jan 2023. 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?
Comparison of mean Receptor Activator Of Nuclear Factor-Kappa B Ligand (RANKL) level between peri-implant health and peri-implant mucositis groups (time frame: this will be done at the beginning of the study, after samples have been collected from all implants in the study.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2023.