Effect of Monolayer Versus Multilayer Leucocyte-Platelet Rich Fibrin (L-PRF) in Interdental Papillary Reconstruction

NCT04091802 | Completed DMC

• 1 other identifier: FDASU-RECO 1214403
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The interdental papilla is very small but it has a great implication from an aesthetic view, more specifically in the anterior region because it is always displayed during smiling. The lack of interdental papilla due to periodontal disease or periodontal therapy leads to aesthetic problems with food stagnation as well as phonetic problem due to the space that allows passage of the air or saliva. Leukocyte-PRF (L-PRF) membrane was developed which includes the majority of the platelets in addition to half of the leukocytes so that lymphocytes as well as the platelet growth factors are trapped inside a fibrin network. Multiple layers of L-PRF may have observable effect on tissue regeneration because it increases the number of growth factors and acts as a strong scaffold which helps in creeping of the cells along it as it remains active and in place for more than 7 days. Thus, the aim of this study will be conducted to compare the effect of one layer versus multiple layers of L-PRF in interdental papillary reconstruction.

Conditions

Recession

Keywords

interdental papilla reconstruction; Leucocyte-Platelet Rich Fibrin (L-PRF)

Outcome Measures

Primary Outcomes (1)

• clinical assessment

  papillary height from the tip of the papilla to mesial line angle

  change from baseline to 6 months

Secondary Outcomes (1)

• volumetric analysis

  change from baseline to 6 months

Study Arms (2)

single layer of L-PRF

EXPERIMENTAL

single layer of L-PRF will be put in the vertical incision

Procedure: interdental papilla reconstruction with L-PRF

multiple layers of L-PRF

EXPERIMENTAL

multiple layers of L-PRF will be put in the vertical incision

Procedure: interdental papilla reconstruction with L-PRF

Interventions

interdental papilla reconstruction with L-PRF PROCEDURE

interdental papilla reconstruction with single layer of L-PRF versus multiple layers of L-PRF

multiple layers of L-PRF; single layer of L-PRF

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients diagnosed with black triangles. 2. Both genders aged from 18-40 years. 3. Patients should be systemically free. 4. Patients with Nordland's class I or II. Nordland and Tarnow classified the interdental papilla loss; the classification is based on three anatomic landmarks: the contact point interdentally, the coronal level of the CEJ interproximally and the facial apical level of the cemento-enamel junction (CEJ). \[Nordland WP, et al, 1998\] Four classes were identified
• Normal: The interdental papilla fills up the whole embrasure to the interproximal contact point.
• Class I: Presence of the tip of the papilla between interdental contact point and the interproximal CEJ.
• Class II: Presence of the tip of the papilla at the interproximal CEJ or apical to it but still coronal to the facial CEJ.
• Class III: Presence of the tip of papilla at similar plane with the labial CEJ or apical to it.
• \. The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding.
• \. A band of keratinized tissue should be present around the test teeth ≥ 2 mm. 7. Gingival biotype of the area to be treated is ≥ 2 mm in thickness.

You may not qualify if:

• Acute periapical lesion.
• moderate to severe form of periodontitis.
• Pregnancy and lactation.
• parafunctional habits.
• Smoking, alcoholics or drug abusers.
• Teeth with interdental spacing, rotation or inclination or crowding.
• Vulnerable group of patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Officials

• Nivine H. kheir el den, professor

  faculty of dentistry- ain shams university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator at Ain shams university

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 17, 2019
• Study Start: January 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share