Clinical trial NCT03090906: Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity
Official title: Clinical and Histological Analysis of Soft Tissue Volume Gain and Stability Around Dental Implants Using Autogenous Subepithelial Connective Tissue Grafts Harvested From the Palate or Tuberosity. A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Recession, Gingival
Keywords: volume gain
soft tissue augmentation
dental implants
histology
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Osteology Foundation
First posted: 2017-03-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Soft tissue volume gain
timeFrame: Baseline to 3 months postoperative
measure: Soft tissue stability
timeFrame: 4 months postoperative to 12 months postoperative
Secondary outcomes:
measure: Histology
timeFrame: Baseline
measure: Clinical periodontal parameters Plaque Index and Bleeding on probing
timeFrame: Baseline, 3 months, 4 months, 12 months
measure: Clinical periodontal parameters.Probing depth
timeFrame: Baseline, 3 months, 4 months, 12 months
measure: Clinical periodontal parameters. Width of keratinized tissue
timeFrame: Baseline, 3 months, 4 months, 12 months
Other outcomes:
Locations:
Study officials:
References: