Tissue Transplantation
Conditions
Interventions
This is a double-blind, 2-arm split-mouth randomized controlled clinical study, where 7 patients who met all inclusion and exclusion criteria were selected to participate in the research. All the surg
Sponsors
FAESA-Centro Universitário Espíritosantense
FAESA-Centro Universitário Espíritosantense
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Good oral hygiene with visible plaque index less than 20%; age higher or equal to 18 years; both genders; sufficient tissue availability to harvest an autogenous soft tissue graft from the palate with 12 mm width, 8 mm height, and 2 mm of thickness; soft tissue at the implant site with a thickness inferior to 2 mm; an implant installed for at least 3 months in both sides of the posterior mandible; need for reopening procedure in the implants
Exclusion criteria
Exclusion criteria: Systemic alterations; presence of inflammation or infection involving the regions where the surgical procedures were performed; bone pathology in the implant site; smoking; excessive use of alcohol; drug addiction; diabetes; pregnancy or desire to become pregnant in the next year; history of radiotherapy treatment in the head and neck region, and people who take medications that may interfere with bone remodeling or who have pathologies that affect bone metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to find a greater increase in the volume of peri-implant soft tissue over one year when the autogenous connective tissue extract is used instead of the collagen matrix, verified by the analysis of plaster models obtained through impressions taken previously and subsequently to surgical procedures, based on a statistical analysis comparing both grafts with the confidence level established at 95%.;Outcome found 1: A change in the volume of the peri-implant soft tissue was found after the grafting procedures, favoring the autogenous graft, with an increase of up to 100% in the peri-implant volume when compared to the collagen matrix in the pre-surgical period up to 18 months after the procedure. All patients underwent an alginate impression before the surgical procedure, 6 months, and 18 months later, and all models obtained were scanned to make them digital. Then, all digital models were imported into specific software (CloudCompare) so that soft tissue changes could be measured. After obtaining the data, the data were put into a statistical analysis program (GraphPad) to analyze whether the data obtained were statistically significant. After complete data analysis, it was possible to observe that the change in peri-implant soft tissue increased significantly | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactFausto Frizzera
FAESA Centro Universitário
Outcome results
None listed