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Search / Trial NCT04766255

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

Launched by UNIVERSITAT INTERNACIONAL DE CATALUNYA · Feb 20, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Soft Tissue Graft Acellular Dermal Graft Collagen Matrix

ClinConnect Summary

This clinical trial is studying how different types of graft materials can help improve the thickness of soft tissue around dental implants, which are artificial teeth roots placed in the jawbone. The researchers want to compare three types of materials: a graft taken from the patient's own palate, a porcine collagen matrix (a material made from pig skin), and a porcine acellular dermal matrix (another pig-derived material). They will look at how much soft tissue volume increases and how stable it is over time, specifically checking in at 3 and 15 months after the implant is placed.

To participate in this trial, patients should be at least 18 years old and need a single dental implant with some soft tissue issues, such as thin tissue or gaps. Key requirements include having enough bone structure for the implant and a healthy mouth with minimal plaque and bleeding. Participants can expect to undergo the usual procedure for a dental implant, along with receiving one of the graft materials. It's important to note that certain conditions, like pregnancy, active gum disease, or specific health issues, may prevent someone from joining the study. This research could help improve outcomes for dental implant patients by finding the best way to support the surrounding tissue.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.
  • The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
  • The implant must be located between 2 fixed reference points (i.e. clinical crowns).
  • Anterior and premolar teeth (from premolar to premolar).
  • Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
  • Palate must have ≥2mm of thickness at premolar area.
  • Full mouth plaque and bleeding score \<20%.
  • Exclusion Criteria:
  • Pregnant or lactation.
  • Active periodontal disease.
  • Previous soft tissue augmentation in the area.
  • Need of guided bone regeneration (GBR) during or after the placement of the implant.
  • Heavy smokers (\> 10 cigarettes per day).
  • Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose steroid therapy, bone metabolic diseases, radiation, immunosuppressive disorders, liver function disorder, immunosuppressant disease, autoimmune disease).
  • Allergy to non-steroidal anti-inflammatory drugs.
  • Patients taking medications that cause gingival enlargement.

About Universitat Internacional De Catalunya

The Universitat Internacional de Catalunya (UIC) is a prestigious higher education institution situated in Barcelona, Spain, renowned for its commitment to academic excellence and innovation in research. With a strong emphasis on interdisciplinary collaboration, UIC actively engages in clinical trials that aim to advance medical knowledge and improve patient outcomes. The university's dedicated research teams are equipped with cutting-edge facilities and experienced professionals, enabling them to conduct rigorous studies across various health-related fields. UIC's focus on ethical practices and compliance ensures that all clinical trials are conducted with the highest standards of scientific integrity and participant safety.

Locations

Sant Cugat Del Valles, Barcelona, Spain

Patients applied

CW

TN

AG

3 patients applied

Trial Officials

Andres Pascual La Rocca, DDS

Principal Investigator

Universitat Internacional de Catalunya

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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