A Phase 1/2 interventional study of RGD Peptide in Periodontitis, sponsored by Minia University. Completed at 2 sites in Egypt. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-16.
Sponsored by Minia University · Phase 1/2, Interventional, and Treatment
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
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 45 is close to the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
Patients who received regenerative periodontal therapy last 6 months before the initial examination.
Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with modified minimally invasive surgical technique (M-MIST) alone
Drug: RGD Peptide
Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and hydrogel injection
Drug: RGD Peptide
Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and RGD peptide hydrogel.
Drug: RGD Peptide
adhesion molecules
evaluation of intrabony component dimension component dimension
evaluation of intrabony component dimension (defect base fill) length measured by millimeters
Time frame: 6 months follow up
evaluation of intrabony component dimension
crestal bone level length measured by millimeters
Time frame: 6 months follow up
evaluation of intrabony component dimension
defect width measured by millimeters
Time frame: 6 months follow up
evaluate the clinical parameters attachment gain
The secondary outcomes were to evaluate the clinical attachment gain measured by millimeters
Time frame: 6 months follow up
evaluate the clinical parameters
pocket depth reduction measured by millimeters
Time frame: 6 months follow up
evaluate the clinical parameters
full-mouth plaque index, full mouth sulcular bleeding index by score
Time frame: 6 months follow up
biochemical evaluation
measure bone morphogenetic protein level in gingival crevicular fluid by ELIST test
Time frame: 1, 7,14 days follow up
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Minia University