Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506539
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-06
Brief Title:
Placenta Extract Gel as a Periodontal Local Delivery Drug
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Laboratory Evaluation of Placenta Extract Gel as an Adjunct to Non Surgical Periodontal Therapy in Patients With Grade B Stage II Periodontitis
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Periodontal disease is one of the most prevalent global chronic disorders Pathology affecting the structure surrounding teeth results in inflammation initiated by bacterial aggregation and alteration in their profile
conventional periodontal therapeutics has focused on the control of etiologic agents thereby promoting healing repair of tissues delivery of therapeutic agents into the pocket act as drug reservoirs which could alter pathogenic flora and promote its repair and wound healing Aim of the study Evaluate the effect of locally delivered placenta extract gel as an adjunct to scaling and root planning in the treatment of periodontal pocket Methodology 30 patients with grade B stage II periodontitis will be selected from the Faculty of Dentistry Suez Canal University outpatient clinic and divided into 2 equal groups Group I will have scaling and root planning
Group II will have scaling and root planning with placenta extract gel locally delivered in the periodontal pocket All clinical parameters plaque index gingival index probing pocket depth and clinical attachment and lab investigations vascular endothelial growth factor and fibroblast growth factor will be measured at 01 and 3 months All results will be tabulated and statistically analyzed using the SPSS program
conventional periodontal therapeutics has focused on the control of etiologic agents thereby promoting healing repair of tissues delivery of therapeutic agents into the pocket act as drug reservoirs which could alter pathogenic flora and promote its repair and wound healing Aim of the study Evaluate the effect of locally delivered placenta extract gel as an adjunct to scaling and root planning in the treatment of periodontal pocket Methodology 30 patients with grade B stage II periodontitis will be selected from the Faculty of Dentistry Suez Canal University outpatient clinic and divided into 2 equal groups Group I will have scaling and root planning
Group II will have scaling and root planning with placenta extract gel locally delivered in the periodontal pocket All clinical parameters plaque index gingival index probing pocket depth and clinical attachment and lab investigations vascular endothelial growth factor and fibroblast growth factor will be measured at 01 and 3 months All results will be tabulated and statistically analyzed using the SPSS program
Detailed Description:
Group I control group where subgingival scaling and root planning will be performed and the pocket will be allowed to heal with secondary intention Group II test group where subgingival scaling and root planing and 1ml of human placental extracts gel adsorbed in 30 beads of gelatin foam of 1sq mm will be placed into the pockets with the help of a probe to fill the sulcus to the deepest point coepak will be placed patients will be recalled after seven 12 days to remove the coePak A customized acrylic stent will be fabricated for each patient to provide a reproducible insertion axis for the periodontal probe The stent will be grooved in an occlusal-apical direction for the above-mentioned purpose
Lab assessment
The area will be isolated with cotton rolls gingival crevicular fluid will be collected using a paper point three times for each pocket and samples will be stored at -80
Vascular endothelial growth factor and fibroblast growth factor will be measured for the two groups using the ELISA technique
Clinical assessment
The following parameters will be recorded for the two groups plaque index gingival index depth probing pocket and clinical attachmentSilness and Löe 1964 Löe and Silness 1963 Measurements will be taken from the stent to the deepest probing depth to record Probing pocket depth PPD while Relative Attachment level RAL will be recorded by subtracting the length of the deepest probing depth from the stent from the length from the stent to the cemento-enamel junction All the clinical parameters will be recorded on day 01 months and 3 months and all results will be tabulated and statistically analyzed
Lab assessment
The area will be isolated with cotton rolls gingival crevicular fluid will be collected using a paper point three times for each pocket and samples will be stored at -80
Vascular endothelial growth factor and fibroblast growth factor will be measured for the two groups using the ELISA technique
Clinical assessment
The following parameters will be recorded for the two groups plaque index gingival index depth probing pocket and clinical attachmentSilness and Löe 1964 Löe and Silness 1963 Measurements will be taken from the stent to the deepest probing depth to record Probing pocket depth PPD while Relative Attachment level RAL will be recorded by subtracting the length of the deepest probing depth from the stent from the length from the stent to the cemento-enamel junction All the clinical parameters will be recorded on day 01 months and 3 months and all results will be tabulated and statistically analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None