Status:

UNKNOWN

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

Lead Sponsor:

George Eastman Dental Hospital, Italy

Collaborating Sponsors:

University of Belgrade

Conditions:

Peri-Implantitis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 g...

Detailed 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...

Eligibility Criteria

Inclusion

  • · Be able and willing to provide consent and sign the informed consent form.
  • 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

  • Compromised systemic health which contraindicates the study procedures.
  • 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.

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2023

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT04323540

Start Date

September 1 2020

End Date

December 1 2023

Last Update

March 26 2020

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