Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity

Universitat Internacional de Catalunya

Status: Unknown

Conditions: Recession, Gingival; Tooth Loss

Treatments: Procedure: Soft tissue augmentation tuberosity; Device: Intraoral optical scan; Procedure: Soft tissue augmentation palate

Study type: Interventional

Funder types: Other

Identifiers

NCT03090906

PER- ECL-2011-10-NF

Details and patient eligibility

About

The goal of this study is to compare clinical and histologically the soft tissue changes in terms of volume gain and stability around dental implants in cases where a subepithelial connective tissue graft from the palate or from the tuberosity is used randomly

Full description

Understanding the importance of the soft tissue around implants have lead clinicians to develop surgical approaches to augment it. The majority of them, are described as bilaminar techniques obtaining a subephitelial connective tissue graft (SCTG) from the palate (P). However, recent studies have demonstrated that tuberosity (T) tissue is a very dense and coarse tissue that seems to contain more collagen and less fat and glandular tissue than that from the P, and therefore may have better tissue qualities for soft tissue augmentation, but there is limited scientific evidence comparing these areas.

The main goal of this study is to compare the soft tissue volume gain and stability around implants in cases where a SCTG of the same dimensions from the P or T is used randomly. To calculate volume changes and stability an intraoral optical scan is used and three-dimensional images superimposed.

The secondary goal is to compare histologically both tissues and changes in clinical parameters. Histomorphometry and immunohistochemistry evaluating levels of Type I-III collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13 is performed.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient must be ≥18 years and able to understand the nature of the proposed surgery and to a signed informed consent.
• Implant must be located between 2 fixed reference points i.e. clinical crowns.
• All implants locations with a need of a soft tissue volume augmentation.
• Palate must have ≥2mm of thickness at premolar area.
• Tuberosity > 12mm in length.
• Full mouth plaque and bleeding score <20%.

Exclusion criteria

• Previous soft tissue augmentation in the area.
• Heavy Smokers (> 10 cigarettes per day).
• Local or systemic conditions that would interfere with routine periodontal therapy (non controlled diabetes, liver function disorder, immunosuppressant disease, autoimmune disease).
• Allergy to Non-Steroidal Anti-Inflammatory Drugs.
• Patients taking medications that cause gingival enlargement
• Gingival idiopatic overgrowth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Control group: SCTG from palate

Experimental group

Description:

Soft tissue augmentation palate

Treatment:

Procedure: Soft tissue augmentation palate

Device: Intraoral optical scan

Test group: SCTG from tuberosity

Experimental group

Description:

Soft tissue augmentation tuberosity

Treatment:

Device: Intraoral optical scan

Procedure: Soft tissue augmentation tuberosity