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Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity

Primary Purpose

Tooth Loss, Recession, Gingival

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Soft tissue augmentation palate
Soft tissue augmentation tuberosity
Intraoral optical scan
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring volume gain, soft tissue augmentation, dental implants, histology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Control group: SCTG from palate

    Test group: SCTG from tuberosity

    Arm Description

    Soft tissue augmentation palate

    Soft tissue augmentation tuberosity

    Outcomes

    Primary Outcome Measures

    Soft tissue volume gain
    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
    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

    Histology
    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 Plaque Index and Bleeding on probing
    Plaque index, bleeding on probing expressed as a full mouth %.
    Clinical periodontal parameters.Probing depth
    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
    Width of keratinized tissue expressed in mm, evaluated at medial point at implant and adjacent teeth one.

    Full Information

    First Posted
    January 29, 2017
    Last Updated
    May 3, 2017
    Sponsor
    Universitat Internacional de Catalunya
    Collaborators
    Osteology Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03090906
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat Internacional de Catalunya
    Collaborators
    Osteology Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Loss, Recession, Gingival
    Keywords
    volume gain, soft tissue augmentation, dental implants, histology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group: SCTG from palate
    Arm Type
    Experimental
    Arm Description
    Soft tissue augmentation palate
    Arm Title
    Test group: SCTG from tuberosity
    Arm Type
    Experimental
    Arm Description
    Soft tissue augmentation tuberosity
    Intervention Type
    Procedure
    Intervention Name(s)
    Soft tissue augmentation palate
    Other Intervention Name(s)
    subepithelial connective tissue graft
    Intervention Description
    Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table. Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness. Palate (CG) The double incision was made approximately 2 to 3 mm apical to the gingival margins of premolars. The donor tissue was removed and cross-mattress sutures were used to approximate the wound on the palate. In both groups the epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick.
    Intervention Type
    Procedure
    Intervention Name(s)
    Soft tissue augmentation tuberosity
    Other Intervention Name(s)
    subepithelial connective tissue graft
    Intervention Description
    Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table. Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness. Tuberosity (TG) The double incision was made from the distal of the terminal tooth. A second incision was made perpendicular to the linear incision at a distal point, which joined the two linear incisions. The graft was removed and a crossed horizontal suspension suture was used. Epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick.
    Intervention Type
    Device
    Intervention Name(s)
    Intraoral optical scan
    Intervention Description
    Intraoral optical scan was performed at both groups at baseline, 3 months, 4 months and 12 months to be able to compare volumetric changes.
    Primary Outcome Measure Information:
    Title
    Soft tissue volume gain
    Description
    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.
    Time Frame
    Baseline to 3 months postoperative
    Title
    Soft tissue stability
    Description
    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.
    Time Frame
    4 months postoperative to 12 months postoperative
    Secondary Outcome Measure Information:
    Title
    Histology
    Description
    Descriptive histology and immunohistochemistry evaluating: Type I-III collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13.
    Time Frame
    Baseline
    Title
    Clinical periodontal parameters Plaque Index and Bleeding on probing
    Description
    Plaque index, bleeding on probing expressed as a full mouth %.
    Time Frame
    Baseline, 3 months, 4 months, 12 months
    Title
    Clinical periodontal parameters.Probing depth
    Description
    Probing depth expressed in mm. Evaluated at implant and adjacent teeth. At Mesial, distal, buccal, lingual, mesiobuccal, mesiolingual, distobuccal and distolingual levels.
    Time Frame
    Baseline, 3 months, 4 months, 12 months
    Title
    Clinical periodontal parameters. Width of keratinized tissue
    Description
    Width of keratinized tissue expressed in mm, evaluated at medial point at implant and adjacent teeth one.
    Time Frame
    Baseline, 3 months, 4 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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