Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity

Not Applicable

• Conditions: Tooth Loss; Recession, Gingival
• Interventions: Procedure: Soft tissue augmentation palate; Procedure: Soft tissue augmentation tuberosity; Device: Intraoral optical scan

• Registration Number: NCT03090906
• Lead Sponsor: Universitat Internacional de Catalunya

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2017-01-29
• Primary Completion: 2017-03
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-27
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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%.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group: SCTG from palate	Intraoral optical scan	Soft tissue augmentation palate
Control group: SCTG from palate	Soft tissue augmentation palate	Soft tissue augmentation palate
Test group: SCTG from tuberosity	Soft tissue augmentation tuberosity	Soft tissue augmentation tuberosity
Test group: SCTG from tuberosity	Intraoral optical scan	Soft tissue augmentation tuberosity

Primary Outcome Measures

Name	Time	Method
Soft tissue volume gain	Baseline to 3 months postoperative	Following soft tissue augmentation procedure volume gain is registered using intraoral optical scan. Superposition between three dimensional images from baseline (before augmentation procedure) and 3 months postoperative is done.
Soft tissue stability	4 months postoperative to 12 months postoperative	To evaluate soft tissue stability an intraoral optical scan is performed at 4 and 12 months postoperative. Also a superimposition between 4 months and 12 months optical images is done.

Secondary Outcome Measures

Name	Time	Method
Clinical periodontal parameters Plaque Index and Bleeding on probing	Baseline, 3 months, 4 months, 12 months	Plaque index, bleeding on probing expressed as a full mouth %.
Histology	Baseline	Descriptive histology and immunohistochemistry evaluating: Type I-III collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13.
Clinical periodontal parameters.Probing depth	Baseline, 3 months, 4 months, 12 months	Probing depth expressed in mm. Evaluated at implant and adjacent teeth. At Mesial, distal, buccal, lingual, mesiobuccal, mesiolingual, distobuccal and distolingual levels.
Clinical periodontal parameters. Width of keratinized tissue	Baseline, 3 months, 4 months, 12 months	Width of keratinized tissue expressed in mm, evaluated at medial point at implant and adjacent teeth one.