Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
BOP
1 other identifier
observational
150
1 country
1
Brief 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. Over 15 months, participants will attend 6 visits where clinical measurements and maintenance care will be performed every 3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2023
CompletedStudy Start
First participant enrolled
September 11, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
October 10, 2025
October 1, 2025
4.2 years
September 5, 2023
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and 15 months
Secondary Outcomes (3)
Incidence of BOP
3, 6, 9, 12 and 15 months
Changes in probing depth (PD)
Baseline, 3, 6, 9, 12 and 15 months
Mucosal recession
Baseline, 3, 6, 9, 12 and 15 months
Other Outcomes (1)
Peri-implant mucosal phenotype
Baseline and 15 months
Study Arms (4)
Implants with BOP score 0
Implants with no BOP according to the modified bleeding index at baseline.
Implants with BOP score 1
Implants with a bleeding dot at baseline.
Implants with BOP score 2
Implants with a continuous line of blood that fills the sulcus at baseline.
Implants with BOP score 3
Implants with a profuse bleeding and/or hemorrhage drip at baseline.
Interventions
With the aid of a periodontal probe, the incidence of BOP, as well as PD, recession and KM will be assessed.
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 maintenance will be performed every 3 months.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Ravida, DDS MS
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 5, 2023
First Posted
September 13, 2023
Study Start
September 11, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share