Peri-ImplantitisNCT06128850
Peri-implant Conditions Mimic Periodontal Conditions
An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Except for patients with referred clinical bruxism and uncontrolled medical conditions, the study included 123 implants with implanted fixed prostheses that had lasted at least six months after functional prosthetic loading. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Peri-implant Mucositis, Peri-implant Health
- What is being tested?
- disease
- How many people
- 143 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jul 2022to 31 Mar 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.
Who may be able to join
- Patients between the ages of 18- 70
- Drugs that have a systemically healthy and controlled treatment situation
- Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading
Who cannot join
- Bruxism
- Uncontrolled medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Peri-İmplant and Periodontal Conditions Co-occur: A Cross-Sectional Study
Except for patients with referred clinical bruxism and uncontrolled medical conditions, the study included 123 implants with implanted fixed prostheses that had lasted at least six months after functional prosthetic loading. In all implant patients, the health scale ranged from implants and natural teeth to plaque, gingival index, bleeding in the probe, mouth depth, loss of clinical attachment, and dental implants. The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.
Inclusion Criteria:
Read more
- Patients between the ages of 18- 70
- Drugs that have a systemically healthy and controlled treatment situation
- Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading Among these groups, it was checked whether periodontitis was seen in patients with peri-implantitis, gingivitis in patients with peri-implant mucositis, and whether healthy gums were seen in individuals with peri-implant health.
To determine the health and disease status of individuals' implants, plaque index (Silness Loe 1964), gingival index (Loe Silness 1963), bleeding on probing (Ainoma Bay 1975), pocket depth measurements, and clinical attachment level were collected.
- Being tested
- disease
- Medical subject headings
- Peri-Implantitis, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diseaseOther
compare to diseases
| Study group | Role | What they receive |
|---|---|---|
| Peri-implantitis | Not described Receives: Other: disease | |
| Peri-implant mucositis | Not described Receives: Other: disease | |
| Peri-implant health | Not described Receives: Other: disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth
Measured: Baseline
Gingival index
This measurement is based on the presence or absence of bleeding on gentle probing
Measured: Baseline
Bleeding on probing
Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.
Measured: Baseline
Secondary outcomes (2)
Periodontal pocket depth
a pathologically deepened gingival sulcus around a tooth at the gingival margin.
Measured: Baseline
Clinical attachment level
CAL is calculated by subtracting the gingival margin level from the probing depth.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start4 Jul 2022
- Primary completion4 Jul 2022
- Study completion31 Mar 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 Abant Izzet Baysal UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba ŞAHİN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128850
- Sponsor's protocol ID
- 2022/163
- Status last verified
- Jul 2024
- First submitted
- 8 Nov 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Peri-İmplant and Periodontal Conditions Co-occur: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06128850
- Acronym / sponsor ID
- 2022/163
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 13 Nov 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.
Except for patients with referred clinical bruxism and uncontrolled medical conditions, the study included 123 implants with implanted fixed prostheses that had lasted at least six months after functional prosthetic loading. In all implant patients, the health scale ranged from implants and natural teeth to plaque, gingival index, bleeding in the probe, mouth depth, loss of clinical attachment, and dental implants. The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.
Inclusion Criteria:
- Patients between the ages of 18- 70
- Drugs that have a systemically healthy and controlled treatment situation
- Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading Among these groups, it was checked whether periodontitis was seen in patients with peri-implantitis, gingivitis in patients with peri-implant mucositis, and whether healthy gums were seen in individuals with peri-implant health.
To determine the health and disease status of individuals' implants, plaque index (Silness Loe 1964), gingival index (Loe Silness 1963), bleeding on probing (Ainoma Bay 1975), pocket depth measurements, and clinical attachment level were collected.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis | – | Other: disease |
| Peri-implant mucositis | – | Other: disease |
| Peri-implant health | – | Other: disease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.
Key inclusion criteria (3 listed)
- Patients between the ages of 18- 70
- Drugs that have a systemically healthy and controlled treatment situation
- Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading
Key exclusion criteria (2 listed)
- Bruxism
- Uncontrolled medical conditions
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 |
|---|---|---|
| diseasecompare to diseases | Other | Peri-implant health, Peri-implant mucositis, Peri-implantitis |
Primary outcome
Plaque index
Time frame: Baseline
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth
Gingival index
Time frame: Baseline
This measurement is based on the presence or absence of bleeding on gentle probing
Bleeding on probing
Time frame: Baseline
Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.
2 secondary outcomes
Periodontal pocket depth
Time frame: Baseline
Clinical attachment level
Time frame: Baseline
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 24 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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-Implantitis and Peri-implant Mucositis, run by Abant Izzet Baysal 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 3 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 24 Jul 2024. 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?
Plaque index (time frame: Baseline). The study lists 3 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 24 Jul 2024.