Peri-ImplantitisBOPNCT06033859
Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
An observational study of Peri-Implantitis and Bleeding of Subgingival Space, run by University of Pittsburgh at 1 site in United States.
Trial summary
The primary goal of the present prospective cohort study is to evaluate the effect of varying incidences of BOP at implant sites across 15 months of maintenance visits on the probability of peri-implant disease progression. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Bleeding of Subgingival Space
- What is being tested?
- Clinical measurements, Radiographic measurement and Dental prophylaxis or maintenance
- Type of treatment
- Surgery or procedure
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to Dec 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population from which cases will be recruited are from the patients of record at the University of Pittsburgh Periodontics Department who meet the inclusion criteria of the study.
Who may be able to join
- To be enrolled in the study, the participant must meet the following inclusion criteria:
- adults in good general health (at least ASA 2)
- having ≥ 1 dental implant that was restored before January 2021
- patients of the University of Pittsburgh Periodontics Department
- available for maintenance visits every 3 months for the length of the study
Who cannot join
- Active infectious diseases of any kind
- Pregnant or planning to become pregnant (self-reported)
- Congenital or metabolic bone disorders
- Current heavy smokers: Subjects who have smoked more than 1 pack/day within 6 months of study onset
- Co-morbid conditions that would affect the study outcome or interpretation of study results
- Require treatment for periodontal disease prior to baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression: A Prospective Study
The primary goal of the present prospective cohort study is to evaluate the effect of varying incidences of BOP at implant sites across 15 months of maintenance visits on the probability of peri-implant disease progression. Over 15 months, participants will attend 6 visits where clinical measurements and maintenance care will be performed every 3 months.
Read the detailed description
Screening/Baseline/Maintenance Visit 1 (V1) After participants have consented, their health history will be reviewed, and their vitals including blood pressure and heart rate will be recorded. A dental exam of the teeth and gums will be completed. During this exam, a UNC 15 periodontal probe will be used to perform the clinical assessments. Intraoral photographs will be taken. An x-ray of the implant(s) included in the study will be taken using a customized x-ray holder (created during Visit 1) so that at the end of the study, a final x-ray will be taken in the exact same position. Finally, each participant will receive a dental prophylaxis (D1110) or maintenance (D4910) according to their prior periodontal diagnosis.
Maintenance Visits 2-6 (V2-V6) Participants will return in 3-month intervals at approximately 3, 6, 9, 12, and 15 months (+/- 10 days) for Study Visits V2 - V6. At each of these visits, individuals will be asked about continued participation in the study. Participants will also be asked if there have been any changes to medical or dental history and if they are taking any new medications. Intraoral photographs of the study area will be performed, as well as, collecting measurements from around the dental implant(s), and providing regular dental cleaning. At the 15 month visit, a final x-ray will be taken using the custom x-ray holder made at the first visit.
Clinical and radiographic assessments will include:
- BOP: at each of the 4 measured locations surrounding the implant of interest will be recorded as follows:
- Score 0 - No BOP
- Score 1 - Bleeding dot
- Score 2 - Continuous line of blood that fills the sulcus
- Score 3 - Profuse bleeding and/or hemorrhage drip.
- Probing depths (PD): at 4 locations surrounding the implant of interest (mesiolingual (ML), mesiobuccal (MB), distolingual (DL), and distobuccal (DB)). PD increase must exceed a threshold of 0.8mm to be considered progression.
- Recession: measured at each of the 4 locations surrounding the implant of interest.
- Keratinized mucosa width: measured at the midbuccal aspect of the implant(s).
- Mucosal thickness: assessed with the aid of an endodontic spreader, 2mm below the mucosal margin, at the midbuccal aspect of the implant(s).
- Marginal bone loss (MBL): measured by overlaying the baseline and final radiographs and measuring the change in marginal bone levels. Progression will have to exceed a threshold of 0.5mm to be considered.
- Conditions
- Peri-Implantitis, Bleeding of Subgingival Space
- Being tested
- Clinical measurements, Radiographic measurement, Dental prophylaxis or maintenance
- Keywords
- Bleeding on probing, Peri-implant mucositis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical measurementsDiagnostic test
With the aid of a periodontal probe, the incidence of BOP, as well as PD, recession and KM will be assessed.
Radiographic measurementDiagnostic test
A standardized periapical radiograph of the implant will be completed at the beginning and the end of study to determine the marginal bone loss.
Dental prophylaxis or maintenanceProcedure or surgery
Dental prophylaxis or maintenance will be performed every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Implants with BOP score 0 | Implants with no BOP according to the modified bleeding index at baseline. Receives: Diagnostic Test: Clinical measurements; Diagnostic Test: Radiographic measurement; Procedure: Dental prophylaxis or maintenance | |
| Implants with BOP score 1 | Implants with a bleeding dot at baseline. Receives: Diagnostic Test: Clinical measurements; Diagnostic Test: Radiographic measurement; Procedure: Dental prophylaxis or maintenance | |
| Implants with BOP score 2 | Implants with a continuous line of blood that fills the sulcus at baseline. Receives: Diagnostic Test: Clinical measurements; Diagnostic Test: Radiographic measurement; Procedure: Dental prophylaxis or maintenance | |
| Implants with BOP score 3 | Implants with a profuse bleeding and/or hemorrhage drip at baseline. Receives: Diagnostic Test: Clinical measurements; Diagnostic Test: Radiographic measurement; Procedure: Dental prophylaxis or maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss (MBL)
MBL will be calculated by measuring the difference in marginal bone level between the standardized periapical radiographs. Progression will have to exceed a threshold of 0.5mm to be considered.
Measured: Baseline and 15 months
Secondary outcomes (3)
Incidence of BOP
Changes in BOP at each of the 4 sites assessed in baseline, according to Mombelli et al. (1987):
- Score 0 - No BOP
- Score 1 - Bleeding dot
- Score 2 - Continuous line of blood that fills the sulcus
- Score 3 - Profuse bleeding and/or hemorrhage drip.
Measured: 3, 6, 9, 12 and 15 months
Changes in probing depth (PD)
Differences in probing depth over the study period. PD increase must exceed a threshold of 0.8mm to be considered progression.
Measured: Baseline, 3, 6, 9, 12 and 15 months
Mucosal recession
Measured at each of the 4 locations surrounding the implant of interest.
Measured: Baseline, 3, 6, 9, 12 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start11 Sep 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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 University of PittsburghThe 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
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Ravida, University of Pittsburgh
- Investigators
- Andrea Ravida, DDS MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033859
- Sponsor's protocol ID
- STUDY22060166
- Acronym
- BOP
- Status last verified
- May 2026
- First submitted
- 5 Sep 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression: A Prospective Study
- ClinicalTrials.gov ID
- NCT06033859
- Acronym / sponsor ID
- BOP / STUDY22060166
- Conditions
- Peri-Implantitis, Bleeding of Subgingival Space
- Keywords
- Bleeding on probing, Peri-implant mucositis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Sep 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 primary goal of the present prospective cohort study is to evaluate the effect of varying incidences of BOP at implant sites across 15 months of maintenance visits on the probability of peri-implant disease progression. Over 15 months, participants will attend 6 visits where clinical measurements and maintenance care will be performed every 3 months.
Detailed description
Screening/Baseline/Maintenance Visit 1 (V1) After participants have consented, their health history will be reviewed, and their vitals including blood pressure and heart rate will be recorded. A dental exam of the teeth and gums will be completed. During this exam, a UNC 15 periodontal probe will be used to perform the clinical assessments. Intraoral photographs will be taken. An x-ray of the implant(s) included in the study will be taken using a customized x-ray holder (created during Visit 1) so that at the end of the study, a final x-ray will be taken in the exact same position. Finally, each participant will receive a dental prophylaxis (D1110) or maintenance (D4910) according to their prior periodontal diagnosis.
Maintenance Visits 2-6 (V2-V6) Participants will return in 3-month intervals at approximately 3, 6, 9, 12, and 15 months (+/- 10 days) for Study Visits V2 - V6. At each of these visits, individuals will be asked about continued participation in the study. Participants will also be asked if there have been any changes to medical or dental history and if they are taking any new medications. Intraoral photographs of the study area will be performed, as well as, collecting measurements from around the dental implant(s), and providing regular dental cleaning. At the 15 month visit, a final x-ray will be taken using the custom x-ray holder made at the first visit.
Clinical and radiographic assessments will include:
- BOP: at each of the 4 measured locations surrounding the implant of interest will be recorded as follows:
- Score 0 - No BOP
- Score 1 - Bleeding dot
- Score 2 - Continuous line of blood that fills the sulcus
- Score 3 - Profuse bleeding and/or hemorrhage drip.
- Probing depths (PD): at 4 locations surrounding the implant of interest (mesiolingual (ML), mesiobuccal (MB), distolingual (DL), and distobuccal (DB)). PD increase must exceed a threshold of 0.8mm to be considered progression.
- Recession: measured at each of the 4 locations surrounding the implant of interest.
- Keratinized mucosa width: measured at the midbuccal aspect of the implant(s).
- Mucosal thickness: assessed with the aid of an endodontic spreader, 2mm below the mucosal margin, at the midbuccal aspect of the implant(s).
- Marginal bone loss (MBL): measured by overlaying the baseline and final radiographs and measuring the change in marginal bone levels. Progression will have to exceed a threshold of 0.5mm to be considered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Implants with BOP score 0 | – | Diagnostic Test: Clinical measurements, Diagnostic Test: Radiographic measurement, Procedure: Dental prophylaxis or maintenanceImplants with no BOP according to the modified bleeding index at baseline. |
| Implants with BOP score 1 | – | Diagnostic Test: Clinical measurements, Diagnostic Test: Radiographic measurement, Procedure: Dental prophylaxis or maintenanceImplants with a bleeding dot at baseline. |
| Implants with BOP score 2 | – | Diagnostic Test: Clinical measurements, Diagnostic Test: Radiographic measurement, Procedure: Dental prophylaxis or maintenanceImplants with a continuous line of blood that fills the sulcus at baseline. |
| Implants with BOP score 3 | – | Diagnostic Test: Clinical measurements, Diagnostic Test: Radiographic measurement, Procedure: Dental prophylaxis or maintenanceImplants with a profuse bleeding and/or hemorrhage drip at baseline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population from which cases will be recruited are from the patients of record at the University of Pittsburgh Periodontics Department who meet the inclusion criteria of the study.
Key inclusion criteria (5 listed)
- adults in good general health (at least ASA 2)
- having ≥ 1 dental implant that was restored before January 2021
- patients of the University of Pittsburgh Periodontics Department
- available for maintenance visits every 3 months for the length of the study
Key exclusion criteria (6 listed)
- Active infectious diseases of any kind
- Pregnant or planning to become pregnant (self-reported)
- Congenital or metabolic bone disorders
- Current heavy smokers: Subjects who have smoked more than 1 pack/day within 6 months of study onset
- Co-morbid conditions that would affect the study outcome or interpretation of study results
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 |
|---|---|---|
| Clinical measurementsWith the aid of a periodontal probe, the incidence of BOP, as well as PD, recession and KM will be assessed. | Diagnostic test | Implants with BOP score 0, Implants with BOP score 1, Implants with BOP score 2, Implants with BOP score 3 |
| Radiographic measurementA standardized periapical radiograph of the implant will be completed at the beginning and the end of study to determine the marginal bone loss. | Diagnostic test | Implants with BOP score 0, Implants with BOP score 1, Implants with BOP score 2, Implants with BOP score 3 |
| Dental prophylaxis or maintenanceDental prophylaxis or maintenance will be performed every 3 months. | Procedure or surgery | Implants with BOP score 0, Implants with BOP score 1, Implants with BOP score 2, Implants with BOP score 3 |
Primary outcome
Marginal Bone Loss (MBL)
Time frame: Baseline and 15 months
MBL will be calculated by measuring the difference in marginal bone level between the standardized periapical radiographs. Progression will have to exceed a threshold of 0.5mm to be considered.
3 secondary outcomes
Incidence of BOP
Time frame: 3, 6, 9, 12 and 15 months
Changes in probing depth (PD)
Time frame: Baseline, 3, 6, 9, 12 and 15 months
Mucosal recession
Time frame: Baseline, 3, 6, 9, 12 and 15 months
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 11 May 2026.
- Individual participant dataSharing planned: No
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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.
Andrea Ravida, DDS MS principal investigator
University of Pittsburgh
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 Bleeding of Subgingival Space, run by University of Pittsburgh at 1 site in United States.
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 5 inclusion and 6 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 11 May 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 United States. 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?
Marginal Bone Loss (MBL) (time frame: Baseline and 15 months). 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 11 May 2026.