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

Universitat Internacional de Catalunya

Status and phase: Enrolling; Phase 4

Conditions: Edentulous Alveolar Ridge; Mucogingival Deformity on Edentulous Ridge; Soft Tissue Atrophy

Treatments: Procedure: Implant Placement; Procedure: Soft Tissue graft augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT04766255

PER-ECL-2017-07

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups

Control Group

Active Comparator group

Description:

Implant placement and prosthetic rehabilitation of the missing tooth

Treatment:

Procedure: Implant Placement

SCTG group

Experimental group

Description:

Implant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth.

Treatment:

Procedure: Soft Tissue graft augmentation

Procedure: Implant Placement

CM group

Experimental group

Description:

Implant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth.

Treatment:

Procedure: Soft Tissue graft augmentation

Procedure: Implant Placement

PADM group

Experimental group

Description:

Implant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth.

Treatment:

Procedure: Soft Tissue graft augmentation

Procedure: Implant Placement