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Vertical Soft Tissue Augmentation With CTG vs ADM

Recruiting
18 - 99 years of age
Both
Phase N/A

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Overview

The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative

Description

The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative) when performed for vertical soft tissue augmentation at sites with peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic, and patient-reported outcomes will be evaluated at different time points up to 1 year.

Eligibility

Inclusion criteria:

  • Age ≥ 18 years
  • Periodontally and systemically healthy
  • Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
  • Presence of single functional dental implant in the anterior with a PSTD
  • Implants diagnosed as healthy (Berglundh et al., 2018)

Exclusion criteria are:

  • Contraindications for surgery
  • Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing
  • Patients pregnant or attempting to get pregnant (self-reported)
  • Untreated periodontitis
  • Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018)
  • Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded
  • History of soft tissue grafting at the implant site within the last 6 months

Study details

Implant Complication

NCT05729607

Harvard Medical School (HMS and HSDM)

22 June 2024

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