Dental Implant FailedNCT06508723
Comparison of Dental Implants with Different Surface Properties
A study testing Dental implant placement in people with Dental Implant Failed and Peri-Implantitis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Peri-Implantitis
- What is being tested?
- Dental implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2023to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Please find below the revised text which is clearer and free of any spelling, grammar or punctuation errors:
- The patient must be between the ages of 18 to 99 years.
- The patient should not have any systemic diseases.
- There must be a toothless area in either the mandibular or maxillary region.
- There must be natural teeth present in the opposing arch.
- The patient should be periodontally healthy.
- There should not be any oral or mucosal diseases present.
- There must be sufficient bone present for implant placement, with a diameter of at least 3.5 mm and a height of 8 mm.
Who cannot join
- Please find below a list of factors that may affect dental treatment and require special consideration:
- Patients who fall outside the specified age range.
- Patients with systemic diseases.
- Patients who have received radiotherapy to the head and neck region.
- Patients who have bruxism habits.
- Patients who smoke more than 10 cigarettes per day.
Show all 11Show fewer
- Patients who use drugs that suppress the immune system or impair healing, such as steroids or bisphosphonates.
- Patients with alcohol and substance addiction.
- Patients who do not comply with treatment.
- Pregnant women and those who are breastfeeding.
- Mentally retarded patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Kütahya, 43100
About this study
Official title: Long-term Clinical and Radiographic Comparison of Dental Implants with Different Surface Properties Placed in the Posterior Region
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 question(s) it aims to answer are:
Read more
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.
Read the 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 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
- Dental Implant Failed, Peri-Implantitis
- Being tested
- Dental implant placement
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Other | The group in which implants with a Ti-Ultra surface are placed. Receives: Procedure: Dental implant placement |
| Control Group | Other | The group in which implants with a Ti-Unite surface are placed. Receives: Procedure: Dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant marginal bone loss
The primary outcome was the assessment of marginal bone loss on radiographs at 1-year follow-up.
Measured: 1-year follow-up of all implants after prosthetic loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start5 Apr 2023
- Primary completion5 Sep 2025 (estimated)
- Study completion5 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, prospective
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, Kutahya Health Sciences University
- Investigators
- Berceste Guler Ayyildiz, Principal investigator, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508723
- Sponsor's protocol ID
- 2023-03/04
- Status last verified
- Nov 2024
- First submitted
- 15 Jul 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If contacted, the principal researcher's evaluation will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical and Radiographic Comparison of Dental Implants with Different Surface Properties Placed in the Posterior Region
- ClinicalTrials.gov ID
- NCT06508723
- Acronym / sponsor ID
- 2023-03/04
- Conditions
- Dental Implant Failed, Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 5 Sep 2025 (estimated)
- Study completion
- 5 Sep 2025 (estimated)
- First posted
- 18 Jul 2024 (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.
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 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
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized, controlled, prospective
| Arm | Type | Receives |
|---|---|---|
| Test Group | Other | Procedure: Dental implant placementThe group in which implants with a Ti-Ultra surface are placed. |
| Control Group | Other | Procedure: Dental implant placementThe group in which implants with a Ti-Unite surface are placed. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Please find below the revised text which is clearer and free of any spelling, grammar or punctuation errors:
- The patient must be between the ages of 18 to 99 years.
- The patient should not have any systemic diseases.
- There must be a toothless area in either the mandibular or maxillary region.
- There must be natural teeth present in the opposing arch.
Key exclusion criteria (11 listed)
- Please find below a list of factors that may affect dental treatment and require special consideration:
- Patients who fall outside the specified age range.
- Patients with systemic diseases.
- Patients who have received radiotherapy to the head and neck region.
- Patients who have bruxism habits.
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 |
|---|---|---|
| Dental implant placementThe 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. | Procedure or surgery | Control Group, Test Group |
Primary outcome
Peri-implant marginal bone loss
Time frame: 1-year follow-up of all implants after prosthetic loading
The primary outcome was the assessment of marginal bone loss on radiographs at 1-year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Yes. If contacted, the principal researcher's evaluation will be shared.
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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.
Berceste Guler Ayyildiz principal investigator
Kutahya Health Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant placement in people with Dental Implant Failed and Peri-Implantitis, run by Kutahya Health Sciences 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 8 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: enrolling by invitation, as of the sponsor's last update on 2 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Peri-implant marginal bone loss (time frame: 1-year follow-up of all implants after prosthetic loading). 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 2 Dec 2024.