Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Comparing different graft materials for dental implant soft tissue thickness

Official title: Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.

Run by Universitat Internacional de Catalunya · NCT04766255 · Data updated 2026-11-12

This study is testing which of three different materials used for gum tissue around dental implants helps people have better results and satisfaction after their procedure.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorUniversitat Internacional de Catalunya
Academic / other
Drugs / interventionsradiation
Locations1 site (Sant Cugat del Vallès, Barcelona)
StatusRecruiting
StartedMay 1, 2021
Main results expectedDecember 30, 2025
Study endsDecember 30, 2026
Registry record updatedDecember 11, 2024
Trial IDNCT04766255 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old who require a single dental implant and have specific soft tissue augmentation needs.

Probably not a fit

Patients with active periodontal disease, previous soft tissue augmentation in the area, or those who are heavy smokers may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the changes in soft tissue volume around dental implants using three different graft materials: sub-epithelial connective tissue grafts from the palate, porcine collagen matrix, and porcine acellular dermal matrix. Participants will receive a single dental implant and undergo soft tissue augmentation to address issues like buccal defects and thin biotype. The effectiveness of each graft material will be assessed at 3 and 15 months post-implant placement, focusing on volume gain and stability. Patient-reported outcomes will also be measured to evaluate overall satisfaction and aesthetic results.

Why it matters

Potential benefit: If successful, this study could improve the outcomes of dental implants by identifying the most effective graft material for enhancing soft tissue thickness.

How similar studies have gone: Previous studies have shown varying success with different graft materials in dental implant procedures, making this approach both relevant and necessary for further exploration.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Universitat Internacional de Catalunya
    Sant Cugat del Vallès, Barcelona, Spain
    Recruiting

Study contacts

  • Principal investigator: Andres Pascual La Rocca, DDS — Universitat Internacional de Catalunya
  • Study coordinator: Andres Pascual La Rocca, DDS
  • Email: pascuallarocca@hotmail.com
  • Phone: 0034627725044

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.