Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05922527 |
Other study ID # |
PERIO2:5:1 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2021 |
Est. completion date |
August 20, 2022 |
Study information
Verified date |
August 2023 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The ultimate goal for periodontal management is to obtain true periodontal regeneration.
Periodontal regeneration implies that CAL gain is achieved through the formation of new
cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus
a whole new periodontal apparatus is reconstructed. Combined periodontal regenerative
therapy; including bone grafting are considered a viable treatment option and result in
significantly better clinical outcomes in intrabony defects compared to monotherapy.
This study was conducted as a randomized controlled clinical trial to evaluate clinically and
radiographically the possible predictable results regarding the use of amnion chorion
allograft (ACM) barrier and demineralized freeze dried bone allograft, (DFDBA) versus open
flap debridement (OFD) in treatment of periodontal intrabony defects.
Description:
True periodontal regeneration is the ultimate goal for periodontal management, implies that
clinical attachment level gain is achieved through the formation of new cementum and new
inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new
periodontal apparatus is reconstructed. Various techniques and biomaterials have been used to
achieve periodontal regeneration of intraosseous defects.
In order to compare the effectiveness of various periodontal regenerative therapies in
treating periodontal infrabony defects many systematic reviews were carried out. The use of
guided tissue regeneration (GTR) and the combined therapies as regenerative approaches were
shown to be more effective than flap procedures, nonetheless, the differences between
regenerative therapies to be minor and insignificant.
Amnion chorion placental derived membrane (ACM) has been introduced in periodontal
regenerative therapy owing to its biological properties. It is biocompatible, biodegradable
and promotes proliferation and migration of the adjacent autogenous connective tissue. There
is no single reported incidence of graft rejection, disease transmission or immune response
from using placental tissues since its first documented usage till today. ACM has been used
in many surgical dental procedures as GTR, alveolar bone preservation and guided bone
regeneration. ACM possesses unique features that make it different from other materials used
in this fields. In periodontal regenerative procedures as GTR, ACM assists rapid epithelial
cell growth instead of epithelial cells exclusion as for the traditional concept of GTR. As
epithelial cells are encouraged to migrate rapidly across the ACM barrier, they form an
epithelial seal over the underlying bone graft or bony defect space and do not apically
migrate into the defect .
Several studies support the use of ACM as an effective material alternative to the currently
used materials/techniques for periodontal regeneration procedures, however more well
conducted studies are still needed.
Accordingly, numerous data and researches are available nowadays, which support the great and
variant regenerative capacities of the different periodontal biomaterials that are widely
available and currently used for treatment of periodontal intra-bony defects, especially
DFDBA and ACM. However, minimal radiographic findings were mentioned in the previous
systematic reviews comparing combined regenerative approach and OFD.