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Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences

U

University of Turin

Status

Enrolling

Conditions

Dental Implants

Treatments

Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)
Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)

Study type

Interventional

Funder types

Other

Identifiers

NCT05466006
GFGTurin2

Details and patient eligibility

About

This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or volume stable collagen matrix and evaluated at 3 months after surgery and at 12 months of follow up after crown placement.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Single tooth edentulous space
  • Expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) assessed according to the prosthetically guided position of an implant of 4 mm in diameter planned using the pre-surgical CBCT
  • Completed non-surgical periodontal therapy (if needed)
  • FMPS and FMBS < 20%

Exclusion criteria

  • Age < 18 years old
  • Pregnancy or lactation
  • Heavy smokers (> 10 cigarette/day)
  • Conditions or diseases contraindicating surgical interventions
  • Absence of the expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) verified after implant placement
  • Need for bone regeneration at the implant site

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 2 patient groups

Subepithelial Connective Tissue Graft (SCTG)
Active Comparator group
Description:
Soft tissue augmentation at peri-implant small buccal dehiscence with subepithelial connective tissue graft harvested from the patient's palate
Treatment:
Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)
Volume Stable Collagen Matrix (VCMX)
Experimental group
Description:
Soft tissue augmentation at peri-implant small buccal dehiscence with xenogenic volume stable collagen matrix
Treatment:
Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)

Trial contacts and locations

1

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Central trial contact

Mario Aimetti

Data sourced from clinicaltrials.gov

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