- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06033859
Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression (BOP)
Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression: A Prospective Study
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Andrea Ravida, DDS MS
- Phone Number: 734-730-9678
- Email: andrearavida@pitt.edu
Study Contact Backup
- Name: Carla Sanchez, MS
- Phone Number: 412-624-1179
- Email: cab28@pitt.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh School of Dental Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Implants with BOP score 0
Implants with no BOP according to the modified bleeding index at baseline.
|
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.
|
Implants with BOP score 1
Implants with a bleeding dot at baseline.
|
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.
|
Implants with BOP score 2
Implants with a continuous line of blood that fills the sulcus at baseline.
|
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.
|
Implants with BOP score 3
Implants with a profuse bleeding and/or hemorrhage drip at baseline.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of BOP
Time Frame: 3, 6, 9, 12 and 15 months
|
Changes in BOP at each of the 4 sites assessed in baseline, according to Mombelli et al. (1987):
|
3, 6, 9, 12 and 15 months
|
Changes in probing depth (PD)
Time Frame: Baseline, 3, 6, 9, 12 and 15 months
|
Differences in probing depth over the study period.
PD increase must exceed a threshold of 0.8mm to be considered progression.
|
Baseline, 3, 6, 9, 12 and 15 months
|
Mucosal recession
Time Frame: Baseline, 3, 6, 9, 12 and 15 months
|
Measured at each of the 4 locations surrounding the implant of interest.
|
Baseline, 3, 6, 9, 12 and 15 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peri-implant mucosal phenotype
Time Frame: Baseline and 15 months
|
Assessed by determining the keratinized mucosa (KM) width, measured in millimeters with a periodontal probe, at the mid-buccal aspect of the implant from the gingival margin to the mucogingival junction and the mucosal thickness, measured in millimeters, at the mid-buccal aspect of the implant, 1.5mm below the gingival margin with an endodontic spreader (0.25mm diameter) and endodontic cursor.
|
Baseline and 15 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea Ravida, DDS MS, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22060166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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