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

NCT ID: NCT06021301

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-06-30

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 .

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 .

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Platelet-Rich Fibrin and Microneedling

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmeen Saleh Tolba

Resident at Faculty of Oral and Dental medicine, Cairo University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yasmeen tolba, Resident

Role: PRINCIPAL_INVESTIGATOR

department of periodontology ,cairo university

Locations

Faculty of Dentistry ,Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

yasmeen tolba, Resident

Role: CONTACT

yasmeen.tolba@dentistry.cu.edu.eg

01027453609

Facility Contacts

yasmeen saleh, Resident

Role: primary

yasmeen.tolba@dentistry.cu.edu.egyas

01027453609

Other Identifiers

P E R 3-3-1

Identifier Type: -

Identifier Source: org_study_id