Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508723
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Comparison of Dental Implants With Different Surface Properties
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Long-term Clinical and Radiographic Comparison of Dental Implants With Different Surface Properties Placed in the Posterior Region
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This controlled parallel clinical study aims to compare the effect of fixed prosthetic restorations placed in the posterior region with different implant surfaces on clinical and peri-implant marginal bone loss
The main questions it aims to answer are
Is there a difference between peri-implant marginal bone loss levels in dental implants with two different surfaces placed in the posterior region Is there a difference in peri-implant clinical parameters in dental implants with two different surfaces placed in the posterior region The study includes a test group implant with Ti-Ulta surface and a control group implant with Ti-Unite surface
Two implants with different surfaces will be placed in the bone following the same routine implant placement protocol
The main questions it aims to answer are
Is there a difference between peri-implant marginal bone loss levels in dental implants with two different surfaces placed in the posterior region Is there a difference in peri-implant clinical parameters in dental implants with two different surfaces placed in the posterior region The study includes a test group implant with Ti-Ulta surface and a control group implant with Ti-Unite surface
Two implants with different surfaces will be placed in the bone following the same routine implant placement protocol
Detailed Description:
Dental implants have become one of the most common treatments used for the rehabilitation of lost teeth Dental implant surfaces have been roughened in different ways to increase the degree of osseointegration A recent review reported that five different types of implant surfaces have been documented over more than 10 years These surfaces were evaluated in 5 parts machined titanium plasma spray TPS sprayed SLA sandblasted and acid-etched and anodized The properties of an implant surface have long been identified as an essential factor in achieving and maintaining osseointegration Modifications made to the implant body surface aim to support osseointegration and the reduction of bacterial adhesion Pathogenic microbial colonization can lead to peri-implantitis and peri-implant marginal bone loss resulting in dental implant failure Roughness porosity and surface chemistry are essential factors for osseointegration In particular surface chemistry is vital in increasing cell adhesion
An example of those produced by rearrangement of the outermost surface layer is the Ti-Unite Nobel Biocare AG Zurich Switzerland implant where the oxide thickness is increased and an anodizing process breaks the boundary between titanium crystals Ti-Unite was introduced in 2001 and is among the best-selling dental implant surfaces worldwide Nowadays the Ti-Ultra Nobel Biocare AG Zurich Switzerland surface structure is being introduced This redesigns the surface chemistry and topography to optimize tissue integration at all implant levels Ti-Ultra is an ultra-hydrophilic multizone anodized implant surface with a graduated surface from implant neck to apex There are studies in the literature comparing different implant surfaces
The aim of this study is to compare the effects of fixed prosthetic restorations placed in the posterior region with different implant surfaces on clinical and peri-implant marginal bone loss
The study will be carried out by Kütahya Health Sciences University Faculty of Dentistry Department of Periodontology Systemically healthy patients between the ages of 18 and 99 and patients who have missing teeth in the posterior region and want to have a restoration with a dental implant will be included Patients will be evaluated in two different groups test and control groups Patients were assigned to study groups It will be distributed randomly and with a sealed envelope method While dental implants with a Ti-Ultra surface will be included in the test group dental implants with a Ti-Unite surface will be placed in the control group All patients will undergo implant surgery and prosthetic restorations with the protocol recommended by the same company After functional loading patients will be followed for 12 months and routine clinical evaluations will be performed Measurements and radiographic examinations will be obtained
Before the operation systemic and dental anamnesis will be taken from the patients and clinical measurements will be recorded Periodontal indices such as plaque index gingival index bleeding on probing index and pocket depth will be recorded in both implant groups Before the operation the patients bone amount will be evaluated on cone beam computed tomography and planning will be made In both implant groups keratinized mucosal thickness keratinized mucosal height and vertical mucosal height will be measured in the area where the implant will be placed Before and during the dental implant treatment operation mesial distal buccal and lingual-palatal bone thickness measurements of the implant socket will be made with a digital caliper Post-operative T0 post-prosthetic loading T1 6th month T2 and 1st year T3 periapical x-rays will be taken The amount of peri-implant marginal bone loss will be evaluated using software on standardized control periapical radiographs to be taken at the end of one-year follow-up
An example of those produced by rearrangement of the outermost surface layer is the Ti-Unite Nobel Biocare AG Zurich Switzerland implant where the oxide thickness is increased and an anodizing process breaks the boundary between titanium crystals Ti-Unite was introduced in 2001 and is among the best-selling dental implant surfaces worldwide Nowadays the Ti-Ultra Nobel Biocare AG Zurich Switzerland surface structure is being introduced This redesigns the surface chemistry and topography to optimize tissue integration at all implant levels Ti-Ultra is an ultra-hydrophilic multizone anodized implant surface with a graduated surface from implant neck to apex There are studies in the literature comparing different implant surfaces
The aim of this study is to compare the effects of fixed prosthetic restorations placed in the posterior region with different implant surfaces on clinical and peri-implant marginal bone loss
The study will be carried out by Kütahya Health Sciences University Faculty of Dentistry Department of Periodontology Systemically healthy patients between the ages of 18 and 99 and patients who have missing teeth in the posterior region and want to have a restoration with a dental implant will be included Patients will be evaluated in two different groups test and control groups Patients were assigned to study groups It will be distributed randomly and with a sealed envelope method While dental implants with a Ti-Ultra surface will be included in the test group dental implants with a Ti-Unite surface will be placed in the control group All patients will undergo implant surgery and prosthetic restorations with the protocol recommended by the same company After functional loading patients will be followed for 12 months and routine clinical evaluations will be performed Measurements and radiographic examinations will be obtained
Before the operation systemic and dental anamnesis will be taken from the patients and clinical measurements will be recorded Periodontal indices such as plaque index gingival index bleeding on probing index and pocket depth will be recorded in both implant groups Before the operation the patients bone amount will be evaluated on cone beam computed tomography and planning will be made In both implant groups keratinized mucosal thickness keratinized mucosal height and vertical mucosal height will be measured in the area where the implant will be placed Before and during the dental implant treatment operation mesial distal buccal and lingual-palatal bone thickness measurements of the implant socket will be made with a digital caliper Post-operative T0 post-prosthetic loading T1 6th month T2 and 1st year T3 periapical x-rays will be taken The amount of peri-implant marginal bone loss will be evaluated using software on standardized control periapical radiographs to be taken at the end of one-year follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None