Effect of Internal and External Micro-needling in Treatment of Stage III Periodontitis
NCT Number: NCT06578403
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontal Diseases
Interventions: DEVICE: external microneedling|OTHER: minimally invasive non- surgical periodontal therapy|DEVICE: internal micro_needling
Sponsor: Misr University for Science and Technology
Sex: ALL
Age: ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2025-09-30

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 maintenance.Microneedling (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 it's 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 parameters(GT, 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

Primary Outcome Measures: Probing depth, measure the pocket depth from the gingival margin to the base of the pocket using UNC 15 probe (mm), 6month|Clinical attachment level [CAL]):, measured with the periodontal probe as the distance from the cemento-enamel junction(CEJ) to the base of the pocket by UNC 15 probe (mm), 6month|plaque index, The desirability of distinguishing clearly between the soft debris aggregates' severity and location by system Score 0 = The tooth surface is clean. - Score 1 = The tooth surface appears clean, but dental plaque can be removed from the gingival third with a sharp explorer. - Score 2 = Plaque is visible along the gingival margin. - Score 3 = The tooth surface is covered with abundant plaque, 6 month|Bleeding on probing, 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 is the score criteria: 0: no bleeding 1: one bleeding point appears 2: multiple bleeding points or one bleeding line appear 3: interdental triangle filled with blood 4: excessive bleeding when probing and blood flow to the marginal sulcus, 6 month
Secondary Outcome Measures: A Visual Analogue Scale (VAS), a pain rating scale 1,2,3,4,5,6,7,8,9 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), immediately after phase 1 therapy|Platelet-derived growth factor (PDGF) levels in gingival crevicular fluid, PDGF are major mitogens for many cell types of mesenchymal origin and for some cells that are neuroectodermal in origin, like oligodendrocytes. PDGF have chemoattractant properties and have been involved in bone formation, erythropoiesis, wound healing and angiogenesis, baseline,7,14 days.|crestal bone level, assessment of crestal bone level by periapical x-ray, after 6 month