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

Injectable Platelet-Rich Fibrin and Microneedling For Papillae Reconstruction In Esthetic Zone (A Case Series )

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 .

Study Overview

• Status: Recruiting
• Conditions: Interdental Papillae Reconstruction; Injectable Platelet Rich Fibrin and Microneedling in Papilla Reconstruction
• Intervention / Treatment: Other: Platelet-Rich Fibrin and Microneedling

Detailed Description

The patients diagnosed with black triangles according to Norland classification system for loss of papillary height will be selected. Each patient will receive a proper knowledge of the study protocols along with full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments and will be given personalized oral hygiene instructions. After oral prophylaxis and baseline measurements of insufficient interdental papilla the treatment will be MN and iPRF. 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. The final clinical photographs and measurements will recorded 3 and 6 months of last dose administered . After the intervention, patients will receive oral hygiene instructions that include the roll technique when brushing without the use of floss and toothpick during the study period to minimize trauma to the treated site .

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: yasmeen tolba, Resident; Phone Number: 01027453609; Email: yasmeen.tolba@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of dentistry ,Cairo university
    • Contact: yasmeen saleh, Resident; Phone Number: 01027453609; Email: yasmeen.tolba@dentistry.cu.edu.egyas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: iPRF and Microneedling; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Papillary height	using UNC probe from papillary tip till incisal edge.	at 3,6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: yasmeen tolba, Resident, department of periodontology ,cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 27, 2023
• First Submitted That Met QC Criteria: August 27, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: P E R 3-3-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No