Comparing different graft materials for dental implant soft tissue thickness

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.

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

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitat Internacional de Catalunya (other)
• Drugs / interventions: radiation
• Locations: 1 site (Sant Cugat del Vallès, Barcelona)
• Trial ID: NCT04766255 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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

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.

Where this trial is running

Sant Cugat del Vallès, Barcelona

• 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

Conditions: Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge, soft tissue graft, acellular dermal graft, collagen matrix