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Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.

NCT04766255 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-11

No results posted yet for this study

Summary

The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.

Conditions

  • Soft Tissue Atrophy
  • Mucogingival Deformity on Edentulous Ridge
  • Edentulous Alveolar Ridge

Interventions

PROCEDURE

Soft Tissue graft augmentation

Donor site: SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured. Recipient site: SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture PADM Group: the ADM (NovoMatrix, Biohorizons, Birmingham AL) graft will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture

PROCEDURE

Implant Placement

A crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a healing abutment will be placed.

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • Andres Pascual La Rocca, DDS · Universitat Internacional de Catalunya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2025-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766255 on ClinicalTrials.gov