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

Recruiting now · Phase 4

Conditions studied: Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge

In brief

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.

Key facts

Study ID

NCT04766255

Run by

Universitat Internacional de Catalunya

People needed

60

Starts

2021-05-01

Expected to finish

2026-12-30

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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 is running

• Universitat Internacional de Catalunya — Sant Cugat del Vallès, Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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