Peri-Implantitis Clinical Trial
Official title:
Resective Surgical Treatment of Peri-implantitis. A Randomized Controlled Clinical Trial.
Verified date | June 2020 |
Source | University of Belgrade |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgical treatment of peri-implantitis can be regenerative or resective, depending on defect configuration. The aim of resective therapy of peri-implantitis is to reduce the severity of soft tissue inflammation and stabilize crestal bone levels whilst reducing probing depths.This will be a multicenter randomized controlled trial in which two resective peri-implantitis protocols will be assessed. The aim of this trial is to compare a resective approach in the surgical treatment of peri-implantitis (decontamination performed with titanium brushes and sterile saline) with a resective approach combined with implantoplasty.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 15, 2023 |
Est. primary completion date | September 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - · Patients >18 years old, able to provide consent and willing to undergo study procedures. - Implants in function for at least 1 year. - Patients with implant-supported partial/full jaw restorations having at least one implant diagnosed with peri-implantitis (probing pocket depth [PPD] =6mm, bleeding/suppuration on probing [BoP/SoP+] and marginal bone loss >2 mm compared to a previous radiographic examination or marginal bone level >3 mm (Berglundh et al. 2018) - Patients with suprabony defects and intrabony defects up to 3mm in depth - Retrievability of prosthetic reconstructions prior the surgical treatment (i.e. screw-retained restorations or cement-retained restorations which can easily be removed prior to all study visits) - According to classification by Monje (Monje, 2019), implants presenting Class II, eventually Class IIIa and Class IIIb - No implant mobility - No evidence of occlusal overload - Satisfactory oral hygiene level (FMPS<25%) and periodontal health or localized periodontal inflammation (FMBS<30%) - Treated periodontal disease with adequate periodontal supportive therapy Exclusion Criteria: - · Patients unable or unwilling to comply with study procedures and study visits. - Pregnant or nursing women - Local conditions that may interfere with surgical treatment (non-treated periodontal disease, acute infections, carious lesions, etc.) - Compromised systemic health preventing the patient from attending study visits or representing a contraindication for surgical treatment - Patients with uncontrolled systemic conditions which may affect healing (i.e. diabetes mellitus). Diabetic patients will have to document their level of metabolic control by means of HbA1c and will only be included when HbA1c<7%. - Patients smoking more than 5 cigarettes per day (self-reported) - Patients taking medications known to interfere with gingival or bone metabolism (e.g. calcium channel blockers, bisphosphonates). |
Country | Name | City | State |
---|---|---|---|
Serbia | Iva Milinkovic | Belgrade |
Lead Sponsor | Collaborator |
---|---|
University of Belgrade | George Eastman Dental Hospital, Italy |
Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | probing depth | measured distance in milimeters from the mucosal margin to the bottom of the probeable pocket (mm). | 18 months |
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 |
NCT02375750 -
Treatment of Peri-implantitis Lesions by Using Biomaterial
|
N/A | |
Completed |
NCT03018795 -
Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis
|
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 | |
Enrolling by invitation |
NCT06033859 -
Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
|
||
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 |
NCT04769609 -
Reconstructive Surgical Therapy of Peri-implantitis
|
||
Not yet recruiting |
NCT04323540 -
Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation
|
N/A | |
Completed |
NCT04874467 -
Influence of Keratinized Mucosa on Dental Implants With Mucositis
|
N/A | |
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 |