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

NCT ID: NCT06578403

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-09-30

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.

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 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)

Biological assessment(Platelet-derived growth factor(PDGF) levels in gingival crevicular fluid Assessment of PDGF in gingival crevicular fluid at baseline,7,14 days

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

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

Group Type: ACTIVE_COMPARATOR

minimally invasive non- surgical periodontal therapy

Intervention Type: OTHER

minimally invasive non- surgical periodontal therapy

external intervention

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

Group Type: EXPERIMENTAL

external microneedling

Intervention Type: DEVICE

external micro\_needling

minimally invasive non- surgical periodontal therapy

Intervention Type: OTHER

minimally invasive non- surgical periodontal therapy

internal intervention

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

Group Type: EXPERIMENTAL

minimally invasive non- surgical periodontal therapy

Intervention Type: OTHER

minimally invasive non- surgical periodontal therapy

internal micro_needling

Intervention Type: DEVICE

internal micro\_ needling

Interventions

external microneedling

external micro\_needling

Intervention Type: DEVICE

minimally invasive non- surgical periodontal therapy

minimally invasive non- surgical periodontal therapy

Intervention Type: OTHER

internal micro_needling

internal micro\_ needling

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Misr University for Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Hasnaa Nassar abdelhamied ali

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

hasnaa nassar, B.D.S

Role: CONTACT

hasnaa.nassar@must.edu.eg

01060949487

radwa elsherif, Phd

Role: CONTACT

radwa.mohamed@must.edu.eg

01007800542

Other Identifiers

MisrUST. MICRONEEDLE

Identifier Type: -

Identifier Source: org_study_id