Implant Survival RateNCT06848855
Proton Pump Inhibitor Use and Dental Implant Success
An observational study of Implant Survival Rate and Implant Survival and Success, run by Berkay Tokuç at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate the effects of proton pump inhibitors (PPIs) on the surrounding bone and the survival of dental implants. The main questions it aims to answer are: Does PPI use affect the survival rate of dental implants? Does PPI use influence crestal bone loss and fractal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Survival Rate, Implant Survival and Success
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 15 May 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: The study was conducted with patients who had a history of PPI use for more than six months and systemically healthy individuals who had undergone regular clinical and radiological follow-ups after dental implant placement at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kocaeli University.
Who may be able to join
- Being over 18 years old,
- Having a history of PPI use for more than six months,
- Having at least one bone-level and axially placed dental implant in the maxilla or mandible,
- Having a minimum of one year elapsed since the prosthetic restoration following dental implant placement,
- Having undergone routine clinical follow-ups and radiological evaluations with periapical radiographs taken using the parallel cone technique after dental implant placement.
Who cannot join
- Individuals with a history of PPI use for less than six months,
- Individuals with periapical radiographs of low image quality or with artifacts,
- Individuals for whom the regions selected for fractal analysis on periapical radiographs are not appropriately sized,
- Individuals who have not undergone routine clinical and radiographic follow-ups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Proton Pump Inhibitor Use and Dental Implant Success: a Retrospective Study
The goal of this observational study is to evaluate the effects of proton pump inhibitors (PPIs) on the surrounding bone and the survival of dental implants. The main questions it aims to answer are:
Does PPI use affect the survival rate of dental implants? Does PPI use influence crestal bone loss and fractal dimension (FD) of the surrounding bone?
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractal Dimension Value
Measured: Fractal analysis values were calculated on radiographs within 1 month after the data collection of the patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Nov 2023
- Primary completion15 Apr 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Survival RateStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berkay Tokuç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berkay Tokuç, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848855
- Sponsor's protocol ID
- 2023/295
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Proton Pump Inhibitor Use and Dental Implant Success: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06848855
- Acronym / sponsor ID
- 2023/295
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Berkay TokuçUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 27 Feb 2025 (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 goal of this observational study is to evaluate the effects of proton pump inhibitors (PPIs) on the surrounding bone and the survival of dental implants. The main questions it aims to answer are:
Does PPI use affect the survival rate of dental implants? Does PPI use influence crestal bone loss and fractal dimension (FD) of the surrounding bone?
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted with patients who had a history of PPI use for more than six months and systemically healthy individuals who had undergone regular clinical and radiological follow-ups after dental implant placement at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kocaeli University.
Key inclusion criteria (5 listed)
- Being over 18 years old,
- Having a history of PPI use for more than six months,
- Having at least one bone-level and axially placed dental implant in the maxilla or mandible,
- Having a minimum of one year elapsed since the prosthetic restoration following dental implant placement,
- Having undergone routine clinical follow-ups and radiological evaluations with periapical radiographs taken using the parallel cone technique after dental implant placement.
Key exclusion criteria (4 listed)
- Individuals with a history of PPI use for less than six months,
- Individuals with periapical radiographs of low image quality or with artifacts,
- Individuals for whom the regions selected for fractal analysis on periapical radiographs are not appropriately sized,
- Individuals who have not undergone routine clinical and radiographic follow-ups.
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
Fractal Dimension Value
Time frame: Fractal analysis values were calculated on radiographs within 1 month after the data collection of the patients.
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 27 Feb 2025.
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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 Survival Rate and Implant Survival and Success, run by Berkay Tokuç 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 5 inclusion and 4 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 27 Feb 2025. 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?
Fractal Dimension Value (time frame: Fractal analysis values were calculated on radiographs within 1 month after the data collection of the patients.). 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 27 Feb 2025.