Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue

Status Not yet recruiting

Clinical Trial Summary

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). The test group will be the same with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to grafting materials.

Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, patient-reported outcome measures including an aesthetic self-evaluation.

Clinical Trial Description

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects.

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 ;

Study Design

Related Conditions & MeSH terms

Peri-Implantitis

Clinical Trial Details

NCT number	NCT04323540
Study type	Interventional
Source	George Eastman Dental Hospital, Italy
Contact	Lucrezia Paternò Holtzman, DMD
Phone	+39.06.3241406
Email	lucreziaph@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	September 1, 2020
Completion date	December 1, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms