Peri-Implant HealthImpl_longtermNCT06852599
Long-term Outcomes of Implants in Patients with Periodontitis
An observational study of Peri-Implant Health and Periodontitis, run by Heidelberg University at 1 site in Germany.
Trial summary
The aim of the study is to examine potential influencing factors on the changes in the periodontal parameters probing pocket depth (PPD), bleeding on probing (BOP), and alveolar bone loss (ABL) on implants and control teeth (using a split-mouth design) over five (T-5), 7.5 (T-7), and ten years (T-10) of supportive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Health, Periodontitis, Peri-implant Mucositis
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 30 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 cohort is recruited from patients of the Department of Conservative Dentistry at Heidelberg University Hospital who have undergone systematic periodontal therapy, have a dental implant, and meet the other inclusion criteria.
Who may be able to join
- Patient-related:
- At least one dental implant present
- Age ≥ 18 years at the beginning of the observation period
- Verbal and written consent
- Complete periodontal and dental status at one of the defined observation time points with 6 probing sites per tooth/implant and bleeding on probing (BOP) recorded during the periodontal maintenance phase
- Locally:
- a contralateral control tooth to the implant is present at the first defined observation time point
- BOP recorded on the implant
Who cannot join
- No written and verbal consent
- Younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to examine potential influencing factors on the changes in the periodontal parameters probing pocket depth (PPD), bleeding on probing (BOP), and alveolar bone loss (ABL) on implants and control teeth (using a split-mouth design) over five (T-5), 7.5 (T-7), and ten years (T-10) of supportive periodontal care (SPC). For this purpose, 150 patients with periodontitis and implants are re-examined cross-sectionally (T0), and the changes in the main peri-implant and periodontal target parameters are compared retrospectively at the specified observation time points (T-5, T-7, T-10).
Potential influencing factors to peri-implant conditions include patient-related factors, therapy-related factors and implant-related factors. In addition, patients will be surveyed using validated questionnaires on oral health-related quality of life (OHIP-G14), and a number of common risk factors for periodontits and peri-implant conditions.
- Medical subject headings
- Periodontitis, Peri-Implantitis
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in periodontal pocket depths
Measured: over five, 7.5, and ten years of supportive periodontal care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Sep 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implant HealthStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio Ciardo, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852599
- Sponsor's protocol ID
- S-476/2023
- Acronym
- Impl_longterm
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 6 Mar 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Implants in Patients with Periodontitis
- ClinicalTrials.gov ID
- NCT06852599
- Acronym / sponsor ID
- Impl_longterm / S-476/2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 28 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 aim of the study is to examine potential influencing factors on the changes in the periodontal parameters probing pocket depth (PPD), bleeding on probing (BOP), and alveolar bone loss (ABL) on implants and control teeth (using a split-mouth design) over five (T-5), 7.5 (T-7), and ten years (T-10) of supportive periodontal care (SPC). For this purpose, 150 patients with periodontitis and implants are re-examined cross-sectionally (T0), and the changes in the main peri-implant and periodontal target parameters are compared retrospectively at the specified observation time points (T-5, T-7, T-10).
Potential influencing factors to peri-implant conditions include patient-related factors, therapy-related factors and implant-related factors. In addition, patients will be surveyed using validated questionnaires on oral health-related quality of life (OHIP-G14), and a number of common risk factors for periodontits and peri-implant conditions.
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
- The study cohort is recruited from patients of the Department of Conservative Dentistry at Heidelberg University Hospital who have undergone systematic periodontal therapy, have a dental implant, and meet the other inclusion criteria.
Key inclusion criteria (8 listed)
- At least one dental implant present
- Age ≥ 18 years at the beginning of the observation period
- Verbal and written consent
- Complete periodontal and dental status at one of the defined observation time points with 6 probing sites per tooth/implant and bleeding on probing (BOP) recorded during the periodontal maintenance phase
- a contralateral control tooth to the implant is present at the first defined observation time point
Key exclusion criteria (2 listed)
- No written and verbal consent
- Younger than 18 years
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
changes in periodontal pocket depths
Time frame: over five, 7.5, and ten years of supportive periodontal care
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 6 Mar 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 Peri-Implant Health and Periodontitis, run by Heidelberg University at 1 site in Germany.
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 8 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 6 Mar 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 Germany. 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?
changes in periodontal pocket depths (time frame: over five, 7.5, and ten years of supportive periodontal care). 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 6 Mar 2025.