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Primary aim of the study is to evaluate efficacy of RGD adhesion molecule loaded hydrogel with minimally invasive surgical technique in treatment of periodontal intrabony defect at baseline and 6months. Secondary outcome is the biochemical evaluation to detect bone morphogenetic proteins level
Periodontitis is a multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by clinical attachment loss caused by the destruction of the periodontal ligament and loss of supporting bone. One of periodontal therapy goals is regeneration of the lost periodontal attachment apparatus.
. To regenerate healthy periodontal tissue, various clinical techniques were developed to prevent downward epithelial migration and promote periodontal tissue regeneration by the remaining periodontal ligament (PDL) cells or osteoblasts such as open flap debridement (OFD), natural or synthetic filling materials and guided tissue regeneration (GTR).
. Tissue engineering has become one of the most commonly used approaches for bone tissue reconstruction and regeneration, injectable hydrogels have attracted the attention of biomaterials scientists for bone tissue-engineering applications, because they can replace regenerative surgery with a minimally invasive injection method and can form any desired shape, to match irregular defects. Various injectable hydrogels with good moldability and 3D structures have been widely investigated for use in bone tissue engineering.
. Recently a variety of bioactive peptides have been studied and applied for the promotion of bone regeneration to repair local bone defects or treat other bone diseases including extracellular matrix (ECM)- derived peptides, bone morphogenetic proteins (BMPs)-derived peptides and others.
. The arginyl-glycyl-aspartic acid (RGD) peptide is one of bioactive peptides which is the cardinal integrin-binding domain and presents in many extracellular matrix proteins, such as fibronectin and vitronectin. As a part of cell surface signalling, RGD peptide can enhance the expression of osteocalcin (OCN), osteopontin (OPN) and BMP to ensure osteoblast proliferation, differentiation and mineralization.
. The induction of bone depending on the concentration of BMPs which considered important bone biological factors that play essential roles in osteogenesis. BMPs are members of secreted signaling proteins that belong to transforming growth factor beta (TGF-β) superfamily. It has been demonstrated that BMPs induce bone formation by differentiating mesenchymal stem cells to osteoblastic cells
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with modified minimally invasive surgical technique (M-MIST) alone |
|
| Group 2 | Placebo Comparator | Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and hydrogel injection |
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| Group 3 | Active Comparator | Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and RGD peptide hydrogel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGD Peptide | Drug | adhesion molecules |
|
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of intrabony component dimension component dimension | evaluation of intrabony component dimension (defect base fill) length measured by millimeters | 6 months follow up |
| evaluation of intrabony component dimension | crestal bone level length measured by millimeters | 6 months follow up |
| evaluation of intrabony component dimension | defect width measured by millimeters | 6 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the clinical parameters attachment gain | The secondary outcomes were to evaluate the clinical attachment gain measured by millimeters | 6 months follow up |
| evaluate the clinical parameters |
| Measure | Description | Time Frame |
|---|---|---|
| biochemical evaluation | measure bone morphogenetic protein level in gingival crevicular fluid by ELIST test | 1, 7,14 days follow up |
Inclusion Criteria:
- Patients with diagnosis of periodontitis (stage III or IV and grade B or C) according to new American Academy of Periodontology classification (Tonetti et al., 2018a) (Nguyen et al., 2021).
Exclusion Criteria:
Patients who received regenerative periodontal therapy last 6 months before the initial examination.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaimaa Hamdy | Minya | 12345 | Egypt | |||
| Shaimaa Hamdy |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C047981 | arginyl-glycyl-aspartic acid |
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The total of 45 infra-bony defects were randomly divided into 3 equal groups (n=15 each) by simple randomization and all surgeries were done by the same periodontist (Sh.H):
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pocket depth reduction measured by millimeters
| 6 months follow up |
| evaluate the clinical parameters | full-mouth plaque index, full mouth sulcular bleeding index by score | 6 months follow up |
| Minya |
| 123 |
| Egypt |