Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870774
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2023-04-25
Brief Title:
Comparative Analysis Using the Collagen Matrix and Autogenous Graft Clinical Course Aesthetic Results
Sponsor:
IM Sechenov First Moscow State Medical University
Organization:
IM Sechenov First Moscow State Medical University
Study Overview
Official Title:
Soft Tissue Augmentation Around Implants With Collagen Matrix and Autogenous Graft 6-months Prospective Randomized Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was an interventional prospective randomized clinical trial RCT in parallel groups The sample size is 32 patients who were randomly divided into two groups depending on the surgical intervention used First group - patients underwent increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the upper jaw Second group - patients used collagen matrix Fibro-Gide Geistlich Pharma AG Bahnhofstrasse 40 6110 Wolhusen Switzerland registration in Russia 19082020 No FSZ -2020711765 In the postoperative period the value of soft tissue thickness gain severity of pain collateral edema amount of analgesics consumed soft tissue aesthetics keratinized mucosa width quality of life and duration of surgery were assessed
Detailed Description:
The aim of this research was to perform a comparative clinical analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation Thirty two patients diagnosed with partial absence of teeth was examined on the basis of the Department of Surgical Dentistry of the EV Borovsky Institute of Dentistry of IM Sechenov First Moscow State Medical University Patients had a soft tissue thickness deficiency from the vestibular surface in the area of the planned dental implant placement in the distal parts of the mandible which was an indication for its increase All patients were randomly divided into two groups depending on method of soft tissue augmentation used In 1 group n16 transplantation of a free connective tissue graft CTG from tuberosity area of the upper jaw was performed In 2 group n16 collagen matrix Fibro-Gide was used According to gender and age characteristics both groups were comparable Randomization of patients was carried out at the stage of surgical intervention as follows after a dental implant placement and preparation of recipients bed an envelope with a randomly assigned treatment method using a connective tissue graft or a collagen matrix was opened
During the operation incision was made along the top of the alveolar ridge within the defect a full-thickness muco-periosteal flap was elevated Traditional 2-stage dental implantation was performed according to surgical protocols of dental implant systems Astra Tech Dentsply Implants Manufacturing GmbH Germany registration in Russia 27122019 No FSZ 20153214 A free connective tissue graft was harvested in patients of the first group Graft was fixed with a horizontal U-shaped suture to the buccal muco-periosteal flap In second patients group a fragment of the collagen matrix Fibro-Gide was fixed to the buccal muco-periosteal flap Geistlich Pharma AG Bahnhofstrasse 40 6110 Wolhusen Switzerland registration in Russia 19082020 No FSZ - 2020711765 For patients of all groups mobilization of the muco-periosteal flap conducted followed by suturing the wound tightly without tension with simple interrupted sutures
Postoperative recommendations included standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed
During the operation incision was made along the top of the alveolar ridge within the defect a full-thickness muco-periosteal flap was elevated Traditional 2-stage dental implantation was performed according to surgical protocols of dental implant systems Astra Tech Dentsply Implants Manufacturing GmbH Germany registration in Russia 27122019 No FSZ 20153214 A free connective tissue graft was harvested in patients of the first group Graft was fixed with a horizontal U-shaped suture to the buccal muco-periosteal flap In second patients group a fragment of the collagen matrix Fibro-Gide was fixed to the buccal muco-periosteal flap Geistlich Pharma AG Bahnhofstrasse 40 6110 Wolhusen Switzerland registration in Russia 19082020 No FSZ - 2020711765 For patients of all groups mobilization of the muco-periosteal flap conducted followed by suturing the wound tightly without tension with simple interrupted sutures
Postoperative recommendations included standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None