Implant Clinical SurvivalNCT06709508
Retrospective Evaluation of Prosthetic Complications and Peri-implant Bone Resorption in Implant-supported Single Unit Fixed Restorations
An observational study of Implant Clinical Survival and Restoration Survival, run by Özer İşisağ at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the one-year outcomes of implant-supported single-tooth fixed restorations used to replace missing teeth. The aim was to assess the success rates of dental implants and identify potential complications during treatment. A total of 100 individuals aged between 20 and 64 participated in the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Clinical Survival, Restoration Survival
- What is being tested?
- Examination group
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2023to 8 Apr 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing single-unit implant-supported restoration treatment at the Department of Prosthodontics, Afyonkarahisar University of Health Sciences
Who may be able to join
- Participants were required to be over 18
- Not to have any systemic disorders
- Not to smoke
- Have provided consent to the study.
Who cannot join
- Individuals with any systemic or psychiatric disorders
- Who did not have radiographic data immediately after prosthetic loading
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar University of Health Sciences Faculty of Dentistry, Department of Prosthodontics
Afyonkarahisar
About this study
This study evaluated the one-year outcomes of implant-supported single-tooth fixed restorations used to replace missing teeth. The aim was to assess the success rates of dental implants and identify potential complications during treatment. A total of 100 individuals aged between 20 and 64 participated in the study. Patients were evaluated one year after their implant treatments through clinical examinations and radiographic imaging.
Read the detailed description
Aim: The aim of this study was to retrospectively investigate the prosthetic complications and peri-implant bone loss by clinical and radiological examination at the 12th month of implantsupported single-unit fixed restorations.
Materials and Methods: In this retrospective study, 100 volunteer patients, aged between 20 and 64, who received implant-supported single-member fixed restoration treatment, were scanned from the archives and included. The patients were scanned from the archives, called for 12-month follow-ups, and clinical and radiographic evaluations were made. G*Power (G*Power Ver. 3.0.10, Franz Faul, Üniversität Kiel, Germany) package program was used to calculate the sample size. Digital radiographs (periapical-panoramic films) taken from the patients at the end of the implant treatment and at the 12th month follow-up were recorded using Planmeca Romexis® software. ImageJ, a digital image analysis program, was used to evaluate marginal bone loss on radiographs (ImageJ 1.54g- Wayne Rasband and Contributons, National institutes of Health, USA). In evaluating the success and survival of the implants, the criteria in the consensus decisions published at the International Oral Implantology Congress in 2007 were taken as basis. In addition, prosthetic complications such as chipping, screw loosening and decementation; Its relationship with anatomical localization, implant length, implant diameter, abutment type, superstructure material, occlusal table and the condition of the opposing arch was evaluated.
- Conditions
- Implant Clinical Survival, Restoration Survival
- Being tested
- Examination group
- Keywords
- Dental Implant, Implant Supported Fixed Prosthesis, Prosthetic Complication, Bone Loss
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination groupOther
This study differs from other clinical studies because the participants of this study consisted of patients undergoing single-member implant-supported restoration treatment at the Department of Prosthodontics, Afyonkarahisar Health Sciences University.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate
Measured: 12 months
Prosthetic complication rate
This study evaluated the impact of various parameters, including abutment type, occlusal table width, and opposing arch condition, on prosthetic complications such as debonding (descementation), screw loosening, and chipping (porcelain fractures).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start8 Apr 2023
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Clinical SurvivalStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Özer İşisağ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Özer İşisağ, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709508
- Sponsor's protocol ID
- number 2023/4 dated 07.04.2023
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Prosthetic Complications and Peri-implant Bone Resorption in Implant-supported Single Unit Fixed Restorations
- ClinicalTrials.gov ID
- NCT06709508
- Acronym / sponsor ID
- number 2023/4 dated 07.04.2023
- Conditions
- Implant Clinical Survival, Restoration Survival
- Keywords
- Dental Implant, Implant Supported Fixed Prosthesis, Prosthetic Complication, Bone Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Özer İşisağUniversity, hospital or other
- Study start
- 8 Apr 2023 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 29 Nov 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 study evaluated the one-year outcomes of implant-supported single-tooth fixed restorations used to replace missing teeth. The aim was to assess the success rates of dental implants and identify potential complications during treatment. A total of 100 individuals aged between 20 and 64 participated in the study. Patients were evaluated one year after their implant treatments through clinical examinations and radiographic imaging.
Detailed description
Aim: The aim of this study was to retrospectively investigate the prosthetic complications and peri-implant bone loss by clinical and radiological examination at the 12th month of implantsupported single-unit fixed restorations.
Materials and Methods: In this retrospective study, 100 volunteer patients, aged between 20 and 64, who received implant-supported single-member fixed restoration treatment, were scanned from the archives and included. The patients were scanned from the archives, called for 12-month follow-ups, and clinical and radiographic evaluations were made. G*Power (G*Power Ver. 3.0.10, Franz Faul, Üniversität Kiel, Germany) package program was used to calculate the sample size. Digital radiographs (periapical-panoramic films) taken from the patients at the end of the implant treatment and at the 12th month follow-up were recorded using Planmeca Romexis® software. ImageJ, a digital image analysis program, was used to evaluate marginal bone loss on radiographs (ImageJ 1.54g- Wayne Rasband and Contributons, National institutes of Health, USA). In evaluating the success and survival of the implants, the criteria in the consensus decisions published at the International Oral Implantology Congress in 2007 were taken as basis. In addition, prosthetic complications such as chipping, screw loosening and decementation; Its relationship with anatomical localization, implant length, implant diameter, abutment type, superstructure material, occlusal table and the condition of the opposing arch was evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing single-unit implant-supported restoration treatment at the Department of Prosthodontics, Afyonkarahisar University of Health Sciences
Key inclusion criteria (4 listed)
- Participants were required to be over 18
- Not to have any systemic disorders
- Not to smoke
- Have provided consent to the study.
Key exclusion criteria (2 listed)
- Individuals with any systemic or psychiatric disorders
- Who did not have radiographic data immediately after prosthetic loading
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 |
|---|---|---|
| Examination groupThis study differs from other clinical studies because the participants of this study consisted of patients undergoing single-member implant-supported restoration treatment at the Department of Prosthodontics, Afyonkarahisar Health Sciences University. | Other | – |
Primary outcome
Implant survival rate
Time frame: 12 months
Prosthetic complication rate
Time frame: 12 months
This study evaluated the impact of various parameters, including abutment type, occlusal table width, and opposing arch condition, on prosthetic complications such as debonding (descementation), screw loosening, and chipping (porcelain fractures).
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 29 Nov 2024.
- Individual participant dataSharing planned: No
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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 Implant Clinical Survival and Restoration Survival, run by Özer İşisağ 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 4 inclusion and 2 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 29 Nov 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?
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?
Implant survival rate (time frame: 12 months). 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 29 Nov 2024.