Evaluation of the Effect of Periimplant Soft Tissue Phenotype on Marginal Bone Loss

NCT05640284 | Completed

• 1 other identifier: periimplantmicrorna
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is keratinized mucosal thickness (KMT) important in early marginal bone loss and peri implant health?
2. 2.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.

Conditions

Alveolar Bone Loss; Dental Implant; Periimplantitis

Keywords

periimplantitis; MicroRNA; dental implants; soft tissue phenotype; alveolar bone loss

Outcome Measures

Primary Outcomes (17)

• 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.

• 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.

Secondary Outcomes (5)

• 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.

Study Arms (6)

Adequate KMT

Keratinized mucosal thicknesses (KMT) on their buccal surfaces are 2 mm and above.

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.

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.

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.

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".

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.

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

Interventions

Nuclear Factor-Kappa B Ligand (RANKL) analysis DIAGNOSTIC_TEST

samples of peri-implant groove fluid will be taken with paper strips and RANKL assessment will be made

Adequate KMT; Peri-implant health; adequate KGW; inadequate KGW; inadequate KMT; peri-implant mucositis

Osteoprotegerin (OPG) analysis DIAGNOSTIC_TEST

samples of peri-implant groove fluid will be taken with paper strips and OPG assessment will be made

Adequate KMT; Peri-implant health; adequate KGW; inadequate KGW; inadequate KMT; peri-implant mucositis

Tumor Necrosis Factor Alpha (TNF-α) analysis DIAGNOSTIC_TEST

samples of peri-implant groove fluid will be taken with paper strips and TNF-α assessment will be made

Adequate KMT; Peri-implant health; adequate KGW; inadequate KGW; inadequate KMT; peri-implant mucositis

MicroRNA-223 analysis DIAGNOSTIC_TEST

samples of peri-implant groove fluid will be taken with paper strips and MicroRNA-223 assessment will be made

Adequate KMT; Peri-implant health; adequate KGW; inadequate KGW; inadequate KMT; peri-implant mucositis

Microrna-27a analysis DIAGNOSTIC_TEST

samples of peri-implant groove fluid will be taken with paper strips and Microrna-27a assessment will be made

Adequate KMT; Peri-implant health; adequate KGW; inadequate KGW; inadequate KMT; peri-implant mucositis

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, dentistry Faculty

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Peri-Implantitis

Interventions

Radiography, Panoramic

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Radiography, Dental; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnosis, Oral; Dentistry

Study Officials

• zeynep taştan eroğlu

  Necmettin Erbakan University

  STUDY DIRECTOR

• dilek özkan şen

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

• elif öncü

  Lokman Hekim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 7, 2022
• Study Start: December 2, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

TU (1)