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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMisr University for Science and Technology

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or Female systematic health

age ≥ 18 years

Provide informed consent and willingness to cooperate with the study protocol.

Probing depth≥6 mm

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • external microneedling

    Device

    external micro\_needling

  • minimally invasive non- surgical periodontal therapy

    Other intervention

    minimally invasive non- surgical periodontal therapy

  • internal micro_needling

    Device

    internal micro\_ needling

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: controlActive comparator 1 intervention
Group B: external interventionExperimental treatment 2 interventions
Group C: internal interventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Probing depth

measure the pocket depth from the gingival margin to the base of the pocket using UNC 15 probe (mm)

Time frame
6month
2

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)

Time frame
6month
3

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

Time frame
6 month
4

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

Time frame
6 month

Secondary outcomes

1

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)

Time frame
immediately after phase 1 therapy
2

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

Time frame
baseline,7,14 days.
3

crestal bone level

assessment of crestal bone level by periapical x-ray

Time frame
after 6 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: