NCT05640284|Completed
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Sponsor study identifier
observational
87
1 country
1
Study Start
December 2, 2022
Actual (reported)Primary Completion
January 15, 2023
Actual (reported)Study Completion
January 15, 2023
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 25, 2022
Actual (reported)December 2, 2022
Actual (reported)December 7, 2022
Actual (reported)January 15, 2023
Actual (reported)January 15, 2023
Actual (reported)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.
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.
this will be done at the beginning of the study, after samples have been collected from all implants in the study.
Keratinized mucosal thicknesses (KMT) on their buccal surfaces are 2 mm and above.
Keratinized mucosal thicknesses (KMT) on their buccal surfaces are less than 2 mm.
samples of peri-implant groove fluid will be taken with paper strips and RANKL assessment will be made
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.
Necmettin Erbakan University, dentistry Faculty
Konya, Turkey (Türkiye)
zeynep taştan eroğlu
Necmettin Erbakan University
dilek özkan şen
Necmettin Erbakan University
elif öncü
Lokman Hekim University
87 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2022
First Posted
December 7, 2022
Study Start
December 2, 2022
Actual (reported)Peri-implant Soft Tissue Phenotype and Early Marginal Bone Loss After Dental Implant Placement
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 TNF-α
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
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
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
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
this will be done at the beginning of the study, after samples have been collected from all implants in the study.
keratinized gingival width (KGW) on their buccal surfaces are 2 mm and above.
keratinized gingival width (KGW) on their buccal surfaces are less than 2 mm.
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".
"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.
samples of peri-implant groove fluid will be taken with paper strips and OPG assessment will be made
samples of peri-implant groove fluid will be taken with paper strips and TNF-α assessment will be made
samples of peri-implant groove fluid will be taken with paper strips and MicroRNA-223 assessment will be made
samples of peri-implant groove fluid will be taken with paper strips and Microrna-27a assessment will be made
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 15, 2023
Actual (reported)Study Completion
January 15, 2023
Actual (reported)Last Updated
January 25, 2023
Record last verified: 2023-01
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