Effect of Internal and External Micro-needling in Treatment of Stage III Periodontitis

NCT06578403 | Not Yet Recruiting

• 1 other identifier: MisrUST. MICRONEEDLE
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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

Conditions

Periodontal Diseases

Keywords

microneedling; periodontitis; Minimally invasive non-surgical therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• A Visual Analogue Scale (VAS)

  immediately after phase 1 therapy

• Platelet-derived growth factor (PDGF) levels in gingival crevicular fluid

  baseline,7,14 days.

• crestal bone level

  after 6 month

Study Arms (3)

control

ACTIVE COMPARATOR

minimally invasive non-surgical technique (MINST) in management of periodontitis stage III patients.

Other: minimally invasive non- surgical periodontal therapy

external intervention

EXPERIMENTAL

minimally invasive non-surgical technique (MINST) with external microneedle (EMN) periodontitis stage III patients.

Device: external microneedling; Other: minimally invasive non- surgical periodontal therapy

internal intervention

EXPERIMENTAL

minimally invasive non-surgical technique with an internal microneedle (IMN) on periodontitis stage III patients.

Other: minimally invasive non- surgical periodontal therapy; Device: internal micro_needling

Interventions

external microneedling DEVICE

external micro\_needling

external intervention

minimally invasive non- surgical periodontal therapy OTHER

minimally invasive non- surgical periodontal therapy

control; external intervention; internal intervention

internal micro_needling DEVICE

internal micro\_ needling

internal intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• smoker
• 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

Sponsors & Collaborators

• Misr University for Science and Technology: lead

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

hasnaa nassar, B.D.S

CONTACT

01060949487; hasnaa.nassar@must.edu.eg

radwa elsherif, Phd

CONTACT

01007800542; radwa.mohamed@must.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 1:1:1

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: August 29, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08