Comparison of Dental Implants with Different Surface Properties
NCT ID: NCT06508723
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
80 participants
INTERVENTIONAL
2023-04-05
2025-09-05
Brief Summary
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The main question(s) 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
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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 patient's 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Test Group
The group in which implants with a Ti-Ultra surface are placed.
Dental implant placement
The same routine implant placement protocol will be applied to both study groups with different surfaces and will be placed in the bone. After local anesthesia, a full-thickness flap will be raised. The implant socket will be created according to the protocol recommended by the company and all implants will be placed in the socket with a torque force of 35 N and the implants will be placed. Once bleeding control is achieved, the flap will be closed primarily. Healing caps will be installed after 3 months. After waiting for wound healing, prosthetic restoration will be performed.
Control Group
The group in which implants with a Ti-Unite surface are placed.
Dental implant placement
The same routine implant placement protocol will be applied to both study groups with different surfaces and will be placed in the bone. After local anesthesia, a full-thickness flap will be raised. The implant socket will be created according to the protocol recommended by the company and all implants will be placed in the socket with a torque force of 35 N and the implants will be placed. Once bleeding control is achieved, the flap will be closed primarily. Healing caps will be installed after 3 months. After waiting for wound healing, prosthetic restoration will be performed.
Interventions
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Dental implant placement
The same routine implant placement protocol will be applied to both study groups with different surfaces and will be placed in the bone. After local anesthesia, a full-thickness flap will be raised. The implant socket will be created according to the protocol recommended by the company and all implants will be placed in the socket with a torque force of 35 N and the implants will be placed. Once bleeding control is achieved, the flap will be closed primarily. Healing caps will be installed after 3 months. After waiting for wound healing, prosthetic restoration will be performed.
Eligibility Criteria
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Inclusion Criteria
1. The patient must be between the ages of 18 to 99 years.
2. The patient should not have any systemic diseases.
3. There must be a toothless area in either the mandibular or maxillary region.
4. There must be natural teeth present in the opposing arch.
5. The patient should be periodontally healthy.
6. There should not be any oral or mucosal diseases present.
7. There must be sufficient bone present for implant placement, with a diameter of at least 3.5 mm and a height of 8 mm.
Exclusion Criteria
1. Patients who fall outside the specified age range.
2. Patients with systemic diseases.
3. Patients who have received radiotherapy to the head and neck region.
4. Patients who have bruxism habits.
5. Patients who smoke more than 10 cigarettes per day.
6. Patients who use drugs that suppress the immune system or impair healing, such as steroids or bisphosphonates.
7. Patients with alcohol and substance addiction.
8. Patients who do not comply with treatment.
9. Pregnant women and those who are breastfeeding.
10. Mentally retarded patients.
18 Years
99 Years
ALL
Yes
Sponsors
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Kutahya Health Sciences University
OTHER
Responsible Party
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Berceste Guler
assoc.prof.dr.
Principal Investigators
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Berceste Guler Ayyildiz
Role: PRINCIPAL_INVESTIGATOR
Kutahya Health Science University
Locations
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Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Kütahya, , Turkey (Türkiye)
Countries
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Other Identifiers
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2023-03/04
Identifier Type: -
Identifier Source: org_study_id