HealthyRA1-2025NCT07876687
Reject Analysis of Periapical Radiographs of Dental Implants.
An observational study of Healthy, run by University Ghent at 1 site in Belgium.
Trial summary
Periapical radiographs of dental implants, acquired as part of two ongoing research projects, will be retrospectively analyzed using a newly developed image quality scoring form. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2026to 1 Jul 2027
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Fourty-nine fully edentulous patients, either in the upper- and/or lower jaw being treated with a bar-retained overdenture and werd seen at the yearly evaluation after 6 to 8 years of follow-up.
Who may be able to join
- Patients which were treated with dental implants for a bar-retained overdenture in the upper - or lower jaw, as part of two running investigations.
- Fully edentulous for minimally 4 months; Adequate bone volume to receive two or 4 implants
Who cannot join
- <21 years old; Smoking
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Oral Health Sciences - Department of Periodontology and Oral Implantology - P8
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: Reject Analysis in Digital Dental Radiology: Diagnostic Quality Analysis of Peri-apical Radiographs of Dental Implants.
Periapical radiographs of dental implants, acquired as part of two ongoing research projects, will be retrospectively analyzed using a newly developed image quality scoring form. Following an initial classification (Excellent - Acceptable - Rejected), a detailed assessment of the various image quality criteria and any deviations from these criteria will be performed. In addition, the frequency with which radiographs had to be retaken to obtain a diagnostically acceptable image will be evaluated. The influence of anatomical factors (e.g., implant location in the mouth, maxilla or mandible, etc.) and the use of individualized radiographic holders will also be assessed.
Through this retrospective analysis of an existing dataset of implant radiographs, the study aims to identify the factors that have influenced image quality, the ability to accurately assess the surrounding bone level, and the need for repeat radiographic exposures. The findings may contribute to the development of guidelines to improve the quality of periapical radiographs and potentially reduce radiation exposure for patients.
- Conditions
- Healthy
- Keywords
- reject analysis, periapical radiograph, dental implants, quality analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients having received dental implants used for a bar-retained overdenture. | Patients were treated with either 4 implants in the upper jaw or 2 implants in lower jaw as part of 2 running research projects. Periapical radiographs taken during these investigations will be analysed retrospectively . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rejection classification
The percentage of periapical radiographs classified as qualitatively excellent, acceptable or unacceptable.
Measured: Through study completion, an average of 1 year.
Repeat rate
Number of radiographs which were actually repeated as result of unacceptable quality.
Measured: Through study completion, an average of 1 year.
Interexaminer reproducibility of the reject analysis.
The degree of agreement between different examiners when classifying radiographs as rejected, acceptable or excellent, and when identifying the reasons for rejection according to the quality assessment criteria.
Measured: Through study completion, an average of 1 year.
Intra-examiner reproducibility
The degree of agreement within the different examiners when classifying radiographs as rejected, acceptable or excellent, and when identifying the reasons for rejection according to the quality assessment criteria.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Qualitative error classification
Frequency analysis of errors resulting in the rejection of the radiographs.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Christiaens, Prof. Dr., Principal investigator, Department of Periodontology & Oral Implantology, Faculty of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876687
- Sponsor's protocol ID
- ONZ-2025-0437
- Acronym
- RA1-2025
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing individual participant data will not be relevant for analysing the quality of the publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reject Analysis in Digital Dental Radiology: Diagnostic Quality Analysis of Peri-apical Radiographs of Dental Implants.
- ClinicalTrials.gov ID
- NCT07876687
- Acronym / sponsor ID
- RA1-2025 / ONZ-2025-0437
- Conditions
- Healthy
- Keywords
- reject analysis, periapical radiograph, dental implants, quality analysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Oct 2026 (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.
Periapical radiographs of dental implants, acquired as part of two ongoing research projects, will be retrospectively analyzed using a newly developed image quality scoring form. Following an initial classification (Excellent - Acceptable - Rejected), a detailed assessment of the various image quality criteria and any deviations from these criteria will be performed. In addition, the frequency with which radiographs had to be retaken to obtain a diagnostically acceptable image will be evaluated. The influence of anatomical factors (e.g., implant location in the mouth, maxilla or mandible, etc.) and the use of individualized radiographic holders will also be assessed.
Through this retrospective analysis of an existing dataset of implant radiographs, the study aims to identify the factors that have influenced image quality, the ability to accurately assess the surrounding bone level, and the need for repeat radiographic exposures. The findings may contribute to the development of guidelines to improve the quality of periapical radiographs and potentially reduce radiation exposure for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having received dental implants used for a bar-retained overdenture. | – | –Patients were treated with either 4 implants in the upper jaw or 2 implants in lower jaw as part of 2 running research projects. Periapical radiographs taken during these investigations will be analysed retrospectively . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fourty-nine fully edentulous patients, either in the upper- and/or lower jaw being treated with a bar-retained overdenture and werd seen at the yearly evaluation after 6 to 8 years of follow-up.
Key inclusion criteria (2 listed)
- Patients which were treated with dental implants for a bar-retained overdenture in the upper - or lower jaw, as part of two running investigations.
- Fully edentulous for minimally 4 months; Adequate bone volume to receive two or 4 implants
Key exclusion criteria (1 listed)
- <21 years old; Smoking
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
Rejection classification
Time frame: Through study completion, an average of 1 year.
The percentage of periapical radiographs classified as qualitatively excellent, acceptable or unacceptable.
Repeat rate
Time frame: Through study completion, an average of 1 year.
Number of radiographs which were actually repeated as result of unacceptable quality.
Interexaminer reproducibility of the reject analysis.
Time frame: Through study completion, an average of 1 year.
The degree of agreement between different examiners when classifying radiographs as rejected, acceptable or excellent, and when identifying the reasons for rejection according to the quality assessment criteria.
Intra-examiner reproducibility
Time frame: Through study completion, an average of 1 year.
The degree of agreement within the different examiners when classifying radiographs as rejected, acceptable or excellent, and when identifying the reasons for rejection according to the quality assessment criteria.
1 secondary outcome
Qualitative error classification
Time frame: Through study completion, an average of 1 year.
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 15 Oct 2026.
- Individual participant dataSharing planned: No. Sharing individual participant data will not be relevant for analysing the quality of the publication.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Véronique Christiaens, Prof. Dr. principal investigator
Department of Periodontology & Oral Implantology, Faculty of Medicine and Health Sciences
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 Healthy, run by University Ghent at 1 site in Belgium.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. 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 Belgium. 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?
Rejection classification (time frame: Through study completion, an average of 1 year.). The study lists 4 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 15 Oct 2026.