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Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity

NCT03090906 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-05-04

No results posted yet for this study

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

Conditions

  • Tooth Loss
  • Recession, Gingival

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Osteology Foundation

    collaborator OTHER

  • Universitat Internacional de Catalunya

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-03-31
Completion
2017-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090906 on ClinicalTrials.gov