Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation
NCT ID: NCT04323540
Last Updated: 2020-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2020-09-01
2023-12-01
Brief Summary
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Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, patient-reported outcome measures including an aesthetic self-evaluation.
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Detailed Description
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More specifically, the control group will be a "pure" reconstructive approach (xenograft bone graft granules and reservable collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). This is in accordance with gold standard practices of reconstructive therapy of peri-implant defects.
The test group will be treated with the same approach and materials, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to the grafting materials. The graft will be harvested from the homolateral palate (molar region).
Outcomes will include CAL, clinical attachment level (primary outcome), PD or probing depth, MR or mucosal recession, defect resolution (composite outcome made up of simultaneous absence of PD\>5 mm, BOP/SUP and bone level changes \>0.5 mm, PI, BoP or bleeding upon probing, suppuration SUP on probing, SUP on palpation, patient-reported outcome measures including an aesthetic self-evaluation.
The measures will be recorded at baseline, 6-, 12-, 18- and 24 months. Radiographic bone levels will be compared with 2 week image at 12 and 24 months
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Xenograft+collagen membrane
Reconstructive approach (Xenograft+collegen membrane)
Peri-implantitis reconstructive surgery
For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture.
Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area.
Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap.
Xenograft+collagen membrane+autologous soft tissue graft
Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)
Peri-implantitis reconstructive surgery
For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture.
Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area.
Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap.
Interventions
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Peri-implantitis reconstructive surgery
For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture.
Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area.
Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap.
Eligibility Criteria
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Inclusion Criteria
* Be able and willing to comply with study procedures and follow-up appointments required by the study protocol.
* Age\>18 years
* Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) \>6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of \>3 mm from that level will be considered.
* Implants in function (i.e. loaded) for at least 1 year.
* Screw- and cement-retained suprastructures for both fixed and removable prostheses.
Exclusion Criteria
* Pregnant or nursing women.
* Cigarette smoking\>5 per day
* Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c\<7% will be enrolled.
* Patients taking medications known to interfere with gingival or bone metabolism.
18 Years
ALL
Yes
Sponsors
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University of Belgrade
OTHER
George Eastman Dental Hospital, Italy
OTHER
Responsible Party
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Lucrezia Paternò Holtzman
Investigator
Principal Investigators
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Luca Cordaro, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
G. Eastman Dental Hospital Rome, Italy
Central Contacts
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Other Identifiers
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18117
Identifier Type: -
Identifier Source: org_study_id
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