Dental Implant FailedNCT05739461
The Effect of Triangular Neck Design on Crestal Bone Loss
An observational study of Dental Implant Failed, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this retrospective study with 5-year follow-up was to compare crestal bone loss (CBL) and buccal bone thickness (BBT) around triangular cross-section neck (TN) to round neck (RN) implants retaining mandibular overdentures, using cone-beam computed tomography Read more about this study
- Who is it for?
- Ages 59 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Dental implant
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 59 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healty patients who was inserted dental implants with two different designs
Who may be able to join
- Patients over 18 years old.
- Mandibular total edentulism.
- Presence of sufficient residual bone width (>5 mm) and length (>10 mm).
- Sufficient keratinized gingiva crestally (≥4 mm).
- Sufficient interarch space.
- Sufficient vestibular depth.
- Patients had their teeth extracted at least three months before surgery.
Who cannot join
- Patients with any systemic disease or condition that can/could compromise osteointegration (cancer, diabetes mellitus, osteopo- rosis, and cardiovascular diseases).
- Presence of any drug use that could affect bone metabolism.
- Presence of immunocompromising conditions.
- Presence of any pathology in the mandible.
- Allergy to any drugs used in the postoperative period.
- Patients who are smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Triangular Cross-section Neck Design on Crestal Bone Stability in the Anterior Mandible: A Retrospective Study With a 5-year Follow-up
The objective of this retrospective study with 5-year follow-up was to compare crestal bone loss (CBL) and buccal bone thickness (BBT) around triangular cross-section neck (TN) to round neck (RN) implants retaining mandibular overdentures, using cone-beam computed tomography
Read the detailed description
CBL is a multifactorial entity including factors related to patients, surgical technique, prosthetic interventions, and implant design. Thus, new developments in implant micro- and macro-features, such as modifications of surface characteristics and chemistry, type of abutment connection, thread design, and neck design have been introduced over time parallel to recent advances in implantology not only for reducing CBL, but also for preserving buccal bone dimensions around implant. Furthermore, implant neck properties have been considered as a determinant factor involved in maintenance of crestal bone around implant in various trials. Nevertheless, there is no consensus with respect to the design of implant neck for reducing CBL.
The most common implant neck design is the circular one; recently, however, a newly designed implant with a triangular neck (TN) portion was introduced, which has reduction in the neck portion on three sides. This neck design provides compression-free area to alveolar crest during implant insertion to minimize CBL. In addition, TN design also would enhance the BBT by increasing the space between the flat part of the triangle and the buccal bone cortex. Based our previous study with one-year follow-up, despite the implants with novel neck design showed a better crestal bone preservation compared to conventional neck design, long-term clinical trials determining the effect of TN are missing for validating the success of this new design. Unfortunately, the data derived from only very few short-term comparative clinical trials to date do not provide an answer on benefits of TN design over the CN implants regarding preserving crestal bone level.
Thus, this retrospective study with up-to-x-month follow-up aimed to compare CBL and BBT around implants with TN and RN retaining mandibular overdentures. The null hypothesis was that there was a difference in CBL and BBT between two implant designs in the long-term follow-up.
- Conditions
- Dental Implant Failed
- Being tested
- Dental implant
- Keywords
- : buccal bone thickness, crestal bone loss, neck design, peri-implant soft tissue, triangular cross-section neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantOther
Dental implants with triangular cross-section neck design
| Study group | Role | What they receive |
|---|---|---|
| triangular cross-section neck implant | Not described Receives: Other: Dental implant | |
| round cross-section neck implant | Not described Receives: Other: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of crestal bone loss
Measured: February 2023
comparison of buccal bone thickness
Measured: February 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start22 Sep 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkay Tokuç, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739461
- Sponsor's protocol ID
- 2022/158
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Triangular Cross-section Neck Design on Crestal Bone Stability in the Anterior Mandible: A Retrospective Study With a 5-year Follow-up
- ClinicalTrials.gov ID
- NCT05739461
- Acronym / sponsor ID
- 2022/158
- Conditions
- Dental Implant Failed
- Keywords
- : buccal bone thickness, crestal bone loss, neck design, peri-implant soft tissue, triangular cross-section neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 22 Feb 2023 (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.
The objective of this retrospective study with 5-year follow-up was to compare crestal bone loss (CBL) and buccal bone thickness (BBT) around triangular cross-section neck (TN) to round neck (RN) implants retaining mandibular overdentures, using cone-beam computed tomography
Detailed description
CBL is a multifactorial entity including factors related to patients, surgical technique, prosthetic interventions, and implant design. Thus, new developments in implant micro- and macro-features, such as modifications of surface characteristics and chemistry, type of abutment connection, thread design, and neck design have been introduced over time parallel to recent advances in implantology not only for reducing CBL, but also for preserving buccal bone dimensions around implant. Furthermore, implant neck properties have been considered as a determinant factor involved in maintenance of crestal bone around implant in various trials. Nevertheless, there is no consensus with respect to the design of implant neck for reducing CBL.
The most common implant neck design is the circular one; recently, however, a newly designed implant with a triangular neck (TN) portion was introduced, which has reduction in the neck portion on three sides. This neck design provides compression-free area to alveolar crest during implant insertion to minimize CBL. In addition, TN design also would enhance the BBT by increasing the space between the flat part of the triangle and the buccal bone cortex. Based our previous study with one-year follow-up, despite the implants with novel neck design showed a better crestal bone preservation compared to conventional neck design, long-term clinical trials determining the effect of TN are missing for validating the success of this new design. Unfortunately, the data derived from only very few short-term comparative clinical trials to date do not provide an answer on benefits of TN design over the CN implants regarding preserving crestal bone level.
Thus, this retrospective study with up-to-x-month follow-up aimed to compare CBL and BBT around implants with TN and RN retaining mandibular overdentures. The null hypothesis was that there was a difference in CBL and BBT between two implant designs in the long-term follow-up.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triangular cross-section neck implant | – | Other: Dental implant |
| round cross-section neck implant | – | Other: Dental implant |
Who may qualify
- Ages
- 59 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healty patients who was inserted dental implants with two different designs
Key inclusion criteria (7 listed)
- Patients over 18 years old.
- Mandibular total edentulism.
- Presence of sufficient residual bone width (>5 mm) and length (>10 mm).
- Sufficient keratinized gingiva crestally (≥4 mm).
- Sufficient interarch space.
Key exclusion criteria (6 listed)
- Patients with any systemic disease or condition that can/could compromise osteointegration (cancer, diabetes mellitus, osteopo- rosis, and cardiovascular diseases).
- Presence of any drug use that could affect bone metabolism.
- Presence of immunocompromising conditions.
- Presence of any pathology in the mandible.
- Allergy to any drugs used in the postoperative period.
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 implantDental implants with triangular cross-section neck design | Other | round cross-section neck implant, triangular cross-section neck implant |
Primary outcome
comparison of crestal bone loss
Time frame: February 2023
comparison of buccal bone thickness
Time frame: February 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant Failed, run by Kocaeli 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 22 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
comparison of crestal bone loss (time frame: February 2023). The study lists 2 primary outcomes in all. 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 22 Feb 2023.