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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 66
- Primary Endpoint
- Clinical attachment level [CAL]):
Study Overview
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 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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or Female systematic health
- •age ≥ 18 years
- •Provide informed consent and willingness to cooperate with the study protocol.
- •Periodontitis stage III patients:
- •Probing depth≥6 mm
- •CAL ≥5 mm.
- •Radiographic bone loss (Extending to middle and beyond)
- •Tooth loss ≥4 teeth.
- •Each patient contributed a maximum of two sides.
Exclusion Criteria
- •History of antibiotic in previous three months.
- •Pregnant or lactating.
- •Treatment with any systemic drug that influences the healing of hard and soft tissues.
- •Patients who received periodontal treatment in the last 6 months
Arms & Interventions
control
minimally invasive non-surgical technique (MINST) in management of periodontitis stage III patients.
Intervention: minimally invasive non- surgical periodontal therapy (Other)
external intervention
minimally invasive non-surgical technique (MINST) with external microneedle (EMN) periodontitis stage III patients.
Intervention: external microneedling (Device)
external intervention
minimally invasive non-surgical technique (MINST) with external microneedle (EMN) periodontitis stage III patients.
Intervention: minimally invasive non- surgical periodontal therapy (Other)
internal intervention
minimally invasive non-surgical technique with an internal microneedle (IMN) on periodontitis stage III patients.
Intervention: minimally invasive non- surgical periodontal therapy (Other)
internal intervention
minimally invasive non-surgical technique with an internal microneedle (IMN) on periodontitis stage III patients.
Intervention: internal micro_needling (Device)
Outcomes
Primary Outcomes
Clinical attachment level [CAL]):
Time Frame: 6month
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)
Probing depth
Time Frame: 6month
measure the pocket depth from the gingival margin to the base of the pocket using UNC 15 probe (mm)
Bleeding on probing
Time Frame: 6 month
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
plaque index
Time Frame: 6 month
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
Secondary Outcomes
- crestal bone level(after 6 month)
- A Visual Analogue Scale (VAS)(immediately after phase 1 therapy)
- Platelet-derived growth factor (PDGF) levels in gingival crevicular fluid(baseline,7,14 days.)
Investigators
Hasnaa Nassar abdelhamied ali
principle investigator
Misr University for Science and Technology