Peri-ImplantitisNCT05713682
Peri-implantitis Between Periodontitis and Nonperiodontitis Sites With ARP
An observational study of Peri-Implantitis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
The goal of this observational study is to compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation. The main question it aims to answer is: whether the occurrence of PI is associated with reasons for dental extraction because of periodontitis… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 6 Jan 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enrolled consecutive patients who received dental extraction and ARP simultaneously and dental implant treatment at least 4 months after ARP at the Division of Periodontics, Kaohsiung Medical University Hospital
Who may be able to join
- patients aged ≥ 20 years
- patients who required tooth extraction and implant therapy
- at least two bite-wing radiographs: baseline and at least a 6-month follow-up
Who cannot join
- a medical condition as a contraindication to dental surgery, autoimmune disorder, immunosuppression, or uncontrolled diabetes (HbA1c > 7%);
- ong-term nonsteroidal anti-inflammatory drug use
- oral bisphosphonate therapy
- pregnancy or lactation
- the absence of follow-up bite-wing radiograph
- cigarette consumption >10 per day
- a history of head and neck radiotherapy.
About this study
Official title: Prevalence of Peri-implantitis Between Periodontitis and Nonperiodontitis Sites Treated With Alveolar Ridge Preservation: A Retrospective Cohort Study
The goal of this observational study is to compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.
The main question it aims to answer is:
- whether the occurrence of PI is associated with reasons for dental extraction because of periodontitis and nonperiodontitis after alveolar ridge preservation.
Researchers will compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.
- Conditions
- Peri-Implantitis
- Being tested
- alveolar ridge preservation
- Keywords
- peri-implantitis, periodontitis, alveolar ridge preservation
- Medical subject headings
- Peri-Implantitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar ridge preservationProcedure or surgery
bone grafting at extracted sites
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of peri-implantitis
bone loss at implant sites
Measured: 2013-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Apr 2013
- Primary completion1 Dec 2020
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsiang Chou, Master, Study chair, School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713682
- Sponsor's protocol ID
- KMUHIRB-E(I)-20200275
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Peri-implantitis Between Periodontitis and Nonperiodontitis Sites Treated With Alveolar Ridge Preservation: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05713682
- Acronym / sponsor ID
- KMUHIRB-E(I)-20200275
- Conditions
- Peri-Implantitis
- Keywords
- peri-implantitis, periodontitis, alveolar ridge preservation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 6 Feb 2023 (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 compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.
The main question it aims to answer is:
- whether the occurrence of PI is associated with reasons for dental extraction because of periodontitis and nonperiodontitis after alveolar ridge preservation.
Researchers will compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enrolled consecutive patients who received dental extraction and ARP simultaneously and dental implant treatment at least 4 months after ARP at the Division of Periodontics, Kaohsiung Medical University Hospital
Key inclusion criteria (3 listed)
- patients aged ≥ 20 years
- patients who required tooth extraction and implant therapy
- at least two bite-wing radiographs: baseline and at least a 6-month follow-up
Key exclusion criteria (7 listed)
- a medical condition as a contraindication to dental surgery, autoimmune disorder, immunosuppression, or uncontrolled diabetes (HbA1c > 7%);
- ong-term nonsteroidal anti-inflammatory drug use
- oral bisphosphonate therapy
- pregnancy or lactation
- the absence of follow-up bite-wing radiograph
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 |
|---|---|---|
| alveolar ridge preservationbone grafting at extracted sites | Procedure or surgery | – |
Primary outcome
occurrence of peri-implantitis
Time frame: 2013-2020
bone loss at implant sites
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 8 Feb 2023.
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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.
Yu-Hsiang Chou, Master study chair
School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 3 inclusion and 7 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
occurrence of peri-implantitis (time frame: 2013-2020). 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 8 Feb 2023.