Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity

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

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

Study Overview

• Status: Unknown
• Conditions: Tooth Loss; Recession, Gingival
• Intervention / Treatment: Procedure: Soft tissue augmentation palate; Device: Intraoral optical scan; Procedure: Soft tissue augmentation tuberosity

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group: SCTG from palate; Soft tissue augmentation palate	Procedure: Soft tissue augmentation palate; 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.; Other Names: subepithelial connective tissue graft; Device: Intraoral optical scan; Intraoral optical scan was performed at both groups at baseline, 3 months, 4 months and 12 months to be able to compare volumetric changes.
Experimental: Test group: SCTG from tuberosity; Soft tissue augmentation tuberosity	Device: Intraoral optical scan; Intraoral optical scan was performed at both groups at baseline, 3 months, 4 months and 12 months to be able to compare volumetric changes.; Procedure: Soft tissue augmentation tuberosity; 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.; Other Names: subepithelial connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 3 months postoperative
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.	4 months postoperative to 12 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
Clinical periodontal parameters Plaque Index and Bleeding on probing	Plaque index, bleeding on probing expressed as a full mouth %.	Baseline, 3 months, 4 months, 12 months
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.	Baseline, 3 months, 4 months, 12 months
Clinical periodontal parameters. Width of keratinized tissue	Width of keratinized tissue expressed in mm, evaluated at medial point at implant and adjacent teeth one.	Baseline, 3 months, 4 months, 12 months

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Collaborators: Osteology Foundation

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: soft tissue augmentation; histology; dental implants; volume gain
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Periodontal Atrophy; Gingival Recession; Tooth Loss
• Other Study ID Numbers: PER- ECL-2011-10-NF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No