Injectable Platelet-Rich Fibrin and Microneedling For Papillae Reconstruction In Esthetic Zone

NCT06021301 | Unknown Phase 2

• 1 other identifier: P E R 3-3-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The currently available non-surgical techniques for papillary reconstruction did not provide long term maintenance of papillary regeneration, Surgical techniques are invasive and the results are unpredictable . The study is based upon the positive effects of iPRF upon enhancing wound healing in terms of new collagen formation, angiogenesis and increasing keratinized tissue phenotype . iPRF exhibited comparable effects to subepithelial connective tissue graft in papillary reconstruction . The effect of microneedling on the tissue responds as if experiencing tissue trauma and the body's own collagen production is induced to preserve tissue integrity . Growth factors are released immediately after injury, inducing the proliferation of new cells, and fibroblasts are transformed into collagen and elastin fibres from day 5 up to week 8 .

Conditions

Injectable Platelet Rich Fibrin and Microneedling in Papilla Reconstruction; Interdental Papillae Reconstruction

Outcome Measures

Primary Outcomes (1)

• Papillary height

  using UNC probe from papillary tip till incisal edge.

  at 3,6 months

Study Arms (1)

iPRF and Microneedling

EXPERIMENTAL

First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively.

Other: Platelet-Rich Fibrin and Microneedling

Interventions

Platelet-Rich Fibrin and Microneedling OTHER

First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively.

iPRF and Microneedling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonsmoking patients aged above 18 years.
• At least one site with interdental papilla recession in the anterior region of the maxillary or mandibular jaws.
• The distance from the contact point to alveolar bone is crest \< 7 mm.
• Class I or Class II papillary recession, according to Nordland and Tarnow's classification systems (Nordland et al., 1998).
• No active periodontal diseases and good oral hygiene.

You may not qualify if:

• Patients were excluded from the study if they have:
• Spacing or crowding between the teeth to be treated
• Abnormal tooth shape
• Systemic diseases such as diabetes mellitus, hypertension or conditions that alter the outcome of periodontal therapy.
• In addition, patients will be excluded if they are Pregnant and lactating women.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry ,Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• yasmeen tolba, Resident

  department of periodontology ,cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yasmeen tolba, Resident

CONTACT

01027453609; yasmeen.tolba@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Faculty of Oral and Dental medicine, Cairo University.

Model Details: Case Series

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)