Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578403
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Effect of Internal and External Micro-needling in Treatment of Stage III Periodontitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Minimally Invasive Non-surgical Therapy Augmented With Internal Versus External Micro-needling in Treatment of Stage Iii Periodontitis a Randomized Controlled Clinical Trial and Biochemical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Periodontitis is a dysbiotic disease characterized by the destruction of the periodontium alveolar bone cementum periodontal ligament gingiva and considered the main cause of tooth loss which is linked to a change in the microbial community from primarily beneficial bacteria known as symbionts to an imbalance with a high presence of harmful bacteria dysbiosis also known as pathobionts
Ideally periodontal therapy should eliminate inflammation arrest the advancement of periodontal disease enhance appearance and create an environment conducive to health maintenanceMicroneedling MN is known as percutaneous collagen induction therapy Micro injuries created by MN result in minimal superficial bleedings and create a wound-healing The body responds to micro-needling as if its experiencing tissue trauma leading to the release of various growth factors such as platelet-derived growth factors transforming growth factors connective tissue growth factors and fibroblast growth factors These growth factors induce the production of collagen to preserve skin integrity After an injury growth factors are released promoting the proliferation of new cells From day 5 to week 8 fibroblasts produce collagen and elastin fibers thickening the tissue in a process known as neocollagenesis Additionally fibroblasts trigger neoangiogenesis by stimulating the proliferation of endothelial cells in the vessels According to a randomized clinical trial comparing micro-needling and acellular dermal matrix significant improvements were observed in various parametersGT RW RD CAL PD Rec- Red and percentage of root coverage with reduced PI and BOP at 3 and 6 months this study aim to The effect of minimally invasive non-surgical augmented with micro-needling both externally and internally for the management of stage III periodontitis
Ideally periodontal therapy should eliminate inflammation arrest the advancement of periodontal disease enhance appearance and create an environment conducive to health maintenanceMicroneedling MN is known as percutaneous collagen induction therapy Micro injuries created by MN result in minimal superficial bleedings and create a wound-healing The body responds to micro-needling as if its experiencing tissue trauma leading to the release of various growth factors such as platelet-derived growth factors transforming growth factors connective tissue growth factors and fibroblast growth factors These growth factors induce the production of collagen to preserve skin integrity After an injury growth factors are released promoting the proliferation of new cells From day 5 to week 8 fibroblasts produce collagen and elastin fibers thickening the tissue in a process known as neocollagenesis Additionally fibroblasts trigger neoangiogenesis by stimulating the proliferation of endothelial cells in the vessels According to a randomized clinical trial comparing micro-needling and acellular dermal matrix significant improvements were observed in various parametersGT RW RD CAL PD Rec- Red and percentage of root coverage with reduced PI and BOP at 3 and 6 months this study aim to The effect of minimally invasive non-surgical augmented with micro-needling both externally and internally for the management of stage III periodontitis
Detailed Description:
Study Settings and Source of Patients The study will take place in the outpatient clinics of the oral medicine periodontology and Diagnosis department at the Faculty of Oral and Dental Surgery at Misr University for Science and Technology All procedures will be conducted with the approval of the Research Ethics Committee REC of the Faculty of Oral and Dental Surgery at Misr University for Science and Technology
SIX periodontitis stage III patients seeking periodontal therapy will be included in this study The selection of patients will be done after careful clinical radiographic and periodontal examination according to the following inclusion and exclusion criteria
Methods of measurement of outcome
Clinical Parameters
The following parameters will be recorded at baseline 3 months after initial periodontal therapy and after 6 months
1 Probing depth
UNC 15 probe will be used to measure the pocket depth from the gingival margin to the base of the pocket
2 Gingival index GI
It is used to assess gingival inflammation
3 Clinical attachment level CAL
Represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance from the cemento-enamel junction CEJ to the base of the pocket
4 plaque index
The desirability of distinguishing clearly between the soft debris aggregates severity and location
5 Bleeding on probing POB
bleeding indices have been devised some assess bleeding as simply present or absent whereas others use grading in an attempt to assess severity of bleeding
6 Vas index
A Visual Analogue Scale VAS is a pain rating scale 123456789 Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-no pain on the left end 0 cm of the scale and the worst pain on the right end of the scale 10 cm
Biological assessmentPlatelet-derived growth factorPDGF levels in gingival crevicular fluid Assessment of PDGF in gingival crevicular fluid at baseline714 days
SIX periodontitis stage III patients seeking periodontal therapy will be included in this study The selection of patients will be done after careful clinical radiographic and periodontal examination according to the following inclusion and exclusion criteria
Methods of measurement of outcome
Clinical Parameters
The following parameters will be recorded at baseline 3 months after initial periodontal therapy and after 6 months
1 Probing depth
UNC 15 probe will be used to measure the pocket depth from the gingival margin to the base of the pocket
2 Gingival index GI
It is used to assess gingival inflammation
3 Clinical attachment level CAL
Represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance from the cemento-enamel junction CEJ to the base of the pocket
4 plaque index
The desirability of distinguishing clearly between the soft debris aggregates severity and location
5 Bleeding on probing POB
bleeding indices have been devised some assess bleeding as simply present or absent whereas others use grading in an attempt to assess severity of bleeding
6 Vas index
A Visual Analogue Scale VAS is a pain rating scale 123456789 Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-no pain on the left end 0 cm of the scale and the worst pain on the right end of the scale 10 cm
Biological assessmentPlatelet-derived growth factorPDGF levels in gingival crevicular fluid Assessment of PDGF in gingival crevicular fluid at baseline714 days
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