Implant Tissue FailureNCT04054271
Effects of ABO Blood Types on the Survival and Marginal Bone Resorption of Dental Implants
An observational study of Implant Tissue Failure, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates implant survival and marginal bone resorption in patients receiving implant treatment with respect to demographic data and AB0 (groups) blood types. Read more about this study
- Who is it for?
- Ages 19 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Tissue Failure
- How many people
- 963 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2017to 15 Dec 2018
- 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 19 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cross-sectional study was performed on patients who had undergone implant treatment and had prosthetic rehabilitation at the Faculty of Dentistry of the Van Yuzuncu Yil University between 2010 and 2017 and who had been followed up for at least one year.
Who may be able to join
- The inclusion criteria for the study group included being 18 years of age and non-smoker, not having any systemic disease, not having undergone any hard and soft tissue augmentation during implant surgery, having implants placed at bone level, having received cylindrical form implants with SLA surface structure, not missing any follow-up visits after implant surgery evidenced with radiographic recordings, having received flat abutment, having cemented implants, and being rehabilitated with fixed prosthetic restoration.
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates implant survival and marginal bone resorption in patients receiving implant treatment with respect to demographic data and AB0 (groups) blood types.
Read the detailed description
For a successful dental implant, optimal soft and hard tissue characteristics are required. These characteristics include appropriate bone quality and a healthy adherent keratinized gingiva that surrounds the implant neck. The most common complications are peri-implant diseases and marginal bone loss for dental implants. Marginal bone loss around the implant may be observed as a long-term complication due to microbial dental plaque-induced peri-implant inflammatory disease or may be observed in the absence of such a disease.
The immune system and genetic factors are known to have important effects on implant success, and ABO blood types are also included in the genetic factors. In the studies evaluating the association of ABO blood types with increased susceptibility to infection and various systemic diseases, it was reported that the percentages of blood types differed significantly, especially in skeletal-muscle system injuries, fractures and cardiovascular disease susceptibility. Also some researchers reported that blood types may be effective on the bacteria colonization which is the main reason of the periodontal diseases. ABO blood types may have an impact on dental implant success and survival.
- Conditions
- Implant Tissue Failure
- Keywords
- Blood types, Dental implant, Marginal Bone Resorption, Implant Survival
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone resorption measurements (mm) in dental implants.
We evaluated marginal bone resorption in patients receiving implant treatment with respect to ABO blood types. These measurements will be measured by periapical radiographs. Periapical radiographs were taken with a parallel technique to measure the amount of mesial and distal bone resorption in the neck region of the implants.
Measured: 1 year
Implant survival rates according to demographic data
We evaluated implant survival rates by age and sex on a yearly basis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start15 Dec 2017
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Tissue FailureStudies 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
- Cross-sectional
- Enrolment
- 963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054271
- Sponsor's protocol ID
- 29112017/05
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ABO Blood Types on the Survival and Marginal Bone Resorption of Dental Implants
- ClinicalTrials.gov ID
- NCT04054271
- Acronym / sponsor ID
- 29112017/05
- Conditions
- Implant Tissue Failure
- Keywords
- Blood types, Dental implant, Marginal Bone Resorption, Implant Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 963 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 13 Aug 2019 (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 evaluates implant survival and marginal bone resorption in patients receiving implant treatment with respect to demographic data and AB0 (groups) blood types.
Detailed description
For a successful dental implant, optimal soft and hard tissue characteristics are required. These characteristics include appropriate bone quality and a healthy adherent keratinized gingiva that surrounds the implant neck. The most common complications are peri-implant diseases and marginal bone loss for dental implants. Marginal bone loss around the implant may be observed as a long-term complication due to microbial dental plaque-induced peri-implant inflammatory disease or may be observed in the absence of such a disease.
The immune system and genetic factors are known to have important effects on implant success, and ABO blood types are also included in the genetic factors. In the studies evaluating the association of ABO blood types with increased susceptibility to infection and various systemic diseases, it was reported that the percentages of blood types differed significantly, especially in skeletal-muscle system injuries, fractures and cardiovascular disease susceptibility. Also some researchers reported that blood types may be effective on the bacteria colonization which is the main reason of the periodontal diseases. ABO blood types may have an impact on dental implant success and survival.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study was performed on patients who had undergone implant treatment and had prosthetic rehabilitation at the Faculty of Dentistry of the Van Yuzuncu Yil University between 2010 and 2017 and who had been followed up for at least one year.
Key inclusion criteria (1 listed)
- The inclusion criteria for the study group included being 18 years of age and non-smoker, not having any systemic disease, not having undergone any hard and soft tissue augmentation during implant surgery, having implants placed at bone level, having received cylindrical form implants with SLA surface structure, not missing any follow-up visits after implant surgery evidenced with radiographic recordings, having received flat abutment, having cemented implants, and being rehabilitated with fixed prosthetic restoration.
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Marginal bone resorption measurements (mm) in dental implants.
Time frame: 1 year
We evaluated marginal bone resorption in patients receiving implant treatment with respect to ABO blood types. These measurements will be measured by periapical radiographs. Periapical radiographs were taken with a parallel technique to measure the amount of mesial and distal bone resorption in the neck region of the implants.
Implant survival rates according to demographic data
Time frame: 1 year
We evaluated implant survival rates by age and sex on a yearly basis
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 13 Aug 2019.
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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 Tissue Failure, run by Yuzuncu Yil 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 1 inclusion and 1 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 13 Aug 2019. 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?
Marginal bone resorption measurements (mm) in dental implants. (time frame: 1 year). 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 13 Aug 2019.