Implant AssesmentEIPPDRAASNCT05823038
Risk and Aesthetic Assesment in Implant Patient
An observational study of Implant Assesment, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study examines the peri-implant risk assessment diagram and the aesthetic, peri-implant health status, and gingival level around the implant in patients with implants by comparing them in smokers and non-smokers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Assesment
- How many people
- 298 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jul 2022to 5 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 298 dental implants for at least 6 months after functional prosthetic loading were included in the study. Patients are primarily divided into smokers and non-smokers.
Who may be able to join
- 18-70 years old patients
- Patients who are systemically healthy and have a controlled medical condition
- Patients with fixed prosthesis on the implant at least 6 months after the functional prosthetic loading of the dental implant
Who cannot join
- Patients with uncontrolled systemic diseases
- Those who have the habit of bruxism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, Turkey
About this study
Official title: Evaluation of Implant Patients by Peri-implant Disease Risk Analysis and Aesthetic Score
This study examines the peri-implant risk assessment diagram and the aesthetic, peri-implant health status, and gingival level around the implant in patients with implants by comparing them in smokers and non-smokers.
: After completion of the examination, 298 dental implants for at least three months after functional prosthesis loading, except for patients with bruxism and uncontrolled diabetes, were included in the study. Patients are primarily divided into smokers and non-smokers. In all implant patients, plaque, gingival index, bleeding on probing, pocket depth, clinical attachment loss, gingival recession, keratinized thickness, keratinized width, vestibule depth, pink aesthetic score, and peri-implant disease risk analysis are evaluated in sequence.
- Conditions
- Implant Assesment
- Keywords
- Implant disease risk assesment, Pink esthetic score, Implant quality scale, Periodontal health, Periodontal disease
- Medical subject headings
- Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant disease risk assesment
The IDRA algorithm is a promising tool to assess patients at moderate or high risk of developing peri-implantitis. The eight vectors of the diagram include: an assessment of a history of periodontitis, the percentage of sites with bleeding on probing (BOP), the number of teeth/implants with probing depths (PD) ≥5 mm, the ratio of periodontal bone loss (evaluated from a radiograph) divided by the patient's age, periodontitis susceptibility as described by the staging and grading categories from the 2017 World Workshop on the Classification of Periodontal and Peri-implant Diseases , the frequency/compliance with supportive periodontal therapy, the distance from the restorative margin of the implant-supported prosthesis to the marginal bone crest, and prosthesis related factors including cleanability and fit of the implant-supported prosthesis.
Measured: baseline
Pink esthetic scale
With the pink aesthetic score, the post-implant process is scored according to the papilla, tissue contours, gingival level, alveolar process, color, and tissue condition. The thresholds for clinical acceptance, which was currently set at values of 8/14 for the PES. The thresholds for clinical acceptance are currently set at values of 8 to 14 for the PES.
Measured: baseline
Dental implant health scale
The Implant Quality of The Health Scale allows the dentist to evaluate an implant using the listed criteria, place it in the appropriate category of health or disease, and then treat the implant accordingly. Three primary classes were established by the Consensus: success, survival, and failure. The success category describes optimum conditions, the survival category describes implants still in function but not with ideal conditions, and the loss of an implant represents an the implant that should be or already has been removed.
Implant Quality Scale Group Clinical Conditions
- Success (optimum health) a) No pain or tenderness upon function b) 0 mobility c) <2 mm radiographic bone loss from initial surgery d) No exudates history
- Satisfactory survival a) No pain on function b) 0 mobility c) 2-4 mm radiographic bone loss d) No exudates history
- Compromised survival a) May have sensitivity on function b) No mobility c) Radiographic bone loss> 4 mm(less than ½ of implant
Measured: baseline
Keratinized tissue thickness
It is advanced to the bone with a canal file. The distance between the stopper and the tip of the file is measured.
Measured: baseline
Keratinized tissue width
Keratinized mucosa width was defined as the distance between the gingival margin and mucogingival junction at the mid-buccal area
Measured: baseline
Periodontal depth
Measuring the distance from the gingival margin to the mucogingival line with a periodontal probe.
Measured: baseline
Bleeding on probing
To determine the bleeding index on probing, the pocket floor, and the inflammatory state of the pocket epithelium, an evaluation is made according to whether there is bleeding in the sulcus 30 seconds after the pocket depth measurement from 6 regions of all the teeth of the patients: mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual and distolingual.
Measured: baseline
Vestibular depth
Vestibular depth is measured either from crest of lip or from coronal border of the attached gingiva to depth of mucobuccal fold.
Measured: baseline
Secondary outcomes (4)
Plaque index
In the plaque index, the mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, and distolingual regions of the implant or implants and dental plaque thickness to the gingiva are evaluated by probing.
Measured: baseline
Gingival index
The gingival index evaluates bleeding, the most basic sign of inflammation. The implants' mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, and distolingual surfaces are measured.
Measured: baseline
Clinical attachment level
Clinical attachment level/loss measured in mm as distance from the CEJ to the gingival margin.
Measured: baseline
Gingival recession
Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cementoenamel junction.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start4 Jul 2022
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant AssesmentStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 298 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
- Investigators
- Ramazan Kurul, Ass. Prof, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823038
- Sponsor's protocol ID
- 2022/160
- Acronym
- EIPPDRAAS
- Status last verified
- Feb 2025
- First submitted
- 8 Apr 2023
- Last updated
- 4 Feb 2025
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implant Patients by Peri-implant Disease Risk Analysis and Aesthetic Score
- ClinicalTrials.gov ID
- NCT05823038
- Acronym / sponsor ID
- EIPPDRAAS / 2022/160
- Conditions
- Implant Assesment
- Keywords
- Implant disease risk assesment, Pink esthetic score, Implant quality scale, Periodontal health, Periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 21 Apr 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.
This study examines the peri-implant risk assessment diagram and the aesthetic, peri-implant health status, and gingival level around the implant in patients with implants by comparing them in smokers and non-smokers.
: After completion of the examination, 298 dental implants for at least three months after functional prosthesis loading, except for patients with bruxism and uncontrolled diabetes, were included in the study. Patients are primarily divided into smokers and non-smokers. In all implant patients, plaque, gingival index, bleeding on probing, pocket depth, clinical attachment loss, gingival recession, keratinized thickness, keratinized width, vestibule depth, pink aesthetic score, and peri-implant disease risk analysis are evaluated in sequence.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 298 dental implants for at least 6 months after functional prosthetic loading were included in the study. Patients are primarily divided into smokers and non-smokers.
Key inclusion criteria (3 listed)
- 18-70 years old patients
- Patients who are systemically healthy and have a controlled medical condition
- Patients with fixed prosthesis on the implant at least 6 months after the functional prosthetic loading of the dental implant
Key exclusion criteria (2 listed)
- Patients with uncontrolled systemic diseases
- Those who have the habit of bruxism
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
Implant disease risk assesment
Time frame: baseline
The IDRA algorithm is a promising tool to assess patients at moderate or high risk of developing peri-implantitis. The eight vectors of the diagram include: an assessment of a history of periodontitis, the percentage of sites with bleeding on probing (BOP), the number of teeth/implants with probing depths (PD) ≥5 mm, the ratio of periodontal bone loss (evaluated from a radiograph) divided by the patient's age, periodontitis susceptibility as described by the staging and grading categories from the 2017 World Workshop on the Classification of Periodontal and Peri-implant Diseases , the frequency/compliance with supportive periodontal therapy, the distance from the restorative margin of the implant-supported prosthesis to the marginal bone crest, and prosthesis related factors including cleanability and fit of the implant-supported prosthesis.
Pink esthetic scale
Time frame: baseline
With the pink aesthetic score, the post-implant process is scored according to the papilla, tissue contours, gingival level, alveolar process, color, and tissue condition. The thresholds for clinical acceptance, which was currently set at values of 8/14 for the PES. The thresholds for clinical acceptance are currently set at values of 8 to 14 for the PES.
Dental implant health scale
Time frame: baseline
The Implant Quality of The Health Scale allows the dentist to evaluate an implant using the listed criteria, place it in the appropriate category of health or disease, and then treat the implant accordingly. Three primary classes were established by the Consensus: success, survival, and failure. The success category describes optimum conditions, the survival category describes implants still in function but not with ideal conditions, and the loss of an implant represents an the implant that should be or already has been removed. Implant Quality Scale Group Clinical Conditions 1. Success (optimum health) a) No pain or tenderness upon function b) 0 mobility c) <2 mm radiographic bone loss from initial surgery d) No exudates history 2. Satisfactory survival a) No pain on function b) 0 mobility c) 2-4 mm radiographic bone loss d) No exudates history 3. Compromised survival a) May have sensitivity on function b) No mobility c) Radiographic bone loss> 4 mm(less than ½ of implant
Keratinized tissue thickness
Time frame: baseline
It is advanced to the bone with a canal file. The distance between the stopper and the tip of the file is measured.
Keratinized tissue width
Time frame: baseline
Keratinized mucosa width was defined as the distance between the gingival margin and mucogingival junction at the mid-buccal area
Periodontal depth
Time frame: baseline
Measuring the distance from the gingival margin to the mucogingival line with a periodontal probe.
Bleeding on probing
Time frame: baseline
To determine the bleeding index on probing, the pocket floor, and the inflammatory state of the pocket epithelium, an evaluation is made according to whether there is bleeding in the sulcus 30 seconds after the pocket depth measurement from 6 regions of all the teeth of the patients: mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual and distolingual.
Vestibular depth
Time frame: baseline
Vestibular depth is measured either from crest of lip or from coronal border of the attached gingiva to depth of mucobuccal fold.
4 secondary outcomes
Plaque index
Time frame: baseline
Gingival index
Time frame: baseline
Clinical attachment level
Time frame: baseline
Gingival recession
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 4 Feb 2025.
- 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.
Ramazan Kurul, Ass. Prof principal investigator
Abant Izzet Baysal University
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 Assesment, 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 4 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?
Implant disease risk assesment (time frame: baseline). The study lists 8 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 4 Feb 2025.