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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091802
Recruitment Status : Completed
First Posted : September 17, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Amir ahmed Lashin, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Recession Procedure: interdental papilla reconstruction with L-PRF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Monolayer Versus Multilayer Leucocyte-Platelet Rich Fibrin (L-PRF) in Interdental Papillary Reconstruction" (A Randomized Controlled Clinical Study)
Actual Study Start Date : January 2016
Actual Primary Completion Date : July 2019
Actual Study Completion Date : August 2019

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Arm Intervention/treatment
Experimental: single layer of L-PRF
single layer of L-PRF will be put in the vertical incision
Procedure: interdental papilla reconstruction with L-PRF
interdental papilla reconstruction with single layer of L-PRF versus multiple layers of L-PRF

Experimental: multiple layers of L-PRF
multiple layers of L-PRF will be put in the vertical incision
Procedure: interdental papilla reconstruction with L-PRF
interdental papilla reconstruction with single layer of L-PRF versus multiple layers of L-PRF




Primary Outcome Measures :
  1. clinical assessment [ Time Frame: change from baseline to 6 months ]
    papillary height from the tip of the papilla to mesial line angle


Secondary Outcome Measures :
  1. volumetric analysis [ Time Frame: change from baseline to 6 months ]
    intraoral scan with CAD-CAM



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. 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.

      5. The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding.

      6. 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.

Exclusion Criteria:

  1. Acute periapical lesion.
  2. moderate to severe form of periodontitis.
  3. Pregnancy and lactation.
  4. parafunctional habits.
  5. Smoking, alcoholics or drug abusers.
  6. Teeth with interdental spacing, rotation or inclination or crowding.
  7. Vulnerable group of patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091802


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Nivine H. kheir el den, professor faculty of dentistry- ain shams university
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Responsible Party: Sara Amir ahmed Lashin, Principle investigator at Ain shams university, Ain Shams University
ClinicalTrials.gov Identifier: NCT04091802    
Other Study ID Numbers: FDASU-RECO 1214403
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Amir ahmed Lashin, Ain Shams University:
interdental papilla reconstruction
Leucocyte-Platelet Rich Fibrin (L-PRF)