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
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
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
NCT ID
NCT03090906
First Posted
January 29, 2017
Last Updated
May 3, 2017
Sponsor
Universitat Internacional de Catalunya
Collaborators
Osteology Foundation
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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Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity
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