Clinical Trials Logo

Clinical 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. Over 15 months, participants will attend 6 visits where clinical measurements and maintenance care will be performed every 3 months.


Clinical Trial 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: 1. BOP: at each of the 4 measured locations surrounding the implant of interest will be recorded as follows: 1. Score 0 - No BOP 2. Score 1 - Bleeding dot 3. Score 2 - Continuous line of blood that fills the sulcus 4. Score 3 - Profuse bleeding and/or hemorrhage drip. 2. 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. 3. Recession: measured at each of the 4 locations surrounding the implant of interest. 4. Keratinized mucosa width: measured at the midbuccal aspect of the implant(s). 5. Mucosal thickness: assessed with the aid of an endodontic spreader, 2mm below the mucosal margin, at the midbuccal aspect of the implant(s). 6. 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


Related Conditions & MeSH terms


NCT number NCT06033859
Study type Observational
Source University of Pittsburgh
Contact
Status Enrolling by invitation
Phase
Start date September 11, 2023
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT05332327 - Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
Enrolling by invitation NCT06063876 - Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty N/A
Completed NCT04249024 - Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery N/A
Withdrawn NCT03624257 - Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery N/A
Completed NCT03018795 - Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis N/A
Completed NCT02375750 - Treatment of Peri-implantitis Lesions by Using Biomaterial N/A
Completed NCT03157193 - Effect of Hyaluronic Acid on Perimplantitis Phase 4
Enrolling by invitation NCT02575274 - Peri-Implantitis Surgical Treatment an RCT Study Phase 2/Phase 3
Completed NCT04833569 - ICG-PDT, Periimplantitis, Diabetes Mellitus Phase 1
Not yet recruiting NCT04337645 - Resective Surgical Treatment of Peri-implantitis. N/A
Active, not recruiting NCT06390124 - Reconstructive Therapy of Peri-implantitis With PDGF-BB (Gem-21) Phase 4
Enrolling by invitation NCT05675241 - Characterizing the Inflammation Around Dental Implants
Recruiting NCT04983758 - 20-year Implant Survival in Periodontally Healthy and Compromised Patients
Completed NCT04874467 - Influence of Keratinized Mucosa on Dental Implants With Mucositis N/A
Not yet recruiting NCT04323540 - Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation N/A
Completed NCT04769609 - Reconstructive Surgical Therapy of Peri-implantitis
Completed NCT05724706 - An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
Completed NCT04559841 - Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin N/A
Recruiting NCT05906810 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis N/A
Completed NCT05595746 - Radiological Bone Loss on Different Levels of Dental Implants N/A