Effect of Monolayer Versus Multilayer Leucocyte-Platelet Rich Fibrin (L-PRF) in Interdental Papillary Reconstruction
Condition: Recession
Study type: Interventional

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.
    

Detailed description: 
      A total of 20 patients will be selected who are caring about esthetics and concerned to go
      through the management of eradication of "black triangles" by interdental papillae
      reconstruction in esthetic zone and systemically free with Nordland's class I or II and 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, Gingival biotype of the area to be treated is ≥ 2 mm in thickness.

      The study protocol will be explained in details to all patients. Then a signed informed
      consent will be obtained from the patients. The data obtained from patients as well as the
      results of the follow up will be kept confidential.

      The study will be introduced to ethics' committee of Faculty of Dentistry Ain Shams
      University and has to be approved before the start of the study Eligible patients will be
      randomized in a 1:1 ratio into two groups; (Group I) included 10 patients and (Group II)
      included 10 patients. The computer-generated randomization assignment (blocks of 4) and
      allocation concealment will be performed by sealed envelopes containing the randomization
      number prepared by non involved member and sent to principle investigator to assign the
      interventions to patients Group I: 10 patients will undergo interdental papillary
      reconstruction using one layer of L-PRF.

      Group II: 10 patients will receive interdental papillary reconstruction using multiple layers
      of L-PRF (Two or more according to the compressibility in which if ≥1mm, it needs one more
      layer, and if ≤1 mm, then no need to more than 2 layers; it cannot be standardized).

      Procedure:

        1. All patients will receive Phase I therapy including oral hygiene measures and scaling
           and root planning whenever indicated.

        2. Preparation of recipient site:

           The preparation of the recipient site is similar to that described by Reddy.

             -  Anasthesia of the surgical field.

             -  A single vertical incision will be made in the buccal vestibule apical to the
                mucogingival junction in the mid interproximal area of the papilla to be treated.

             -  Intrasulcular releasing incisions will be made on the teeth adjacent to the papilla
                to be augmented and extend to the buccal and palatal aspects without altering the
                integrity of the papilla.

             -  The incisions will maintain the full height and thickness of the gingiva.

             -  Papilla will be undermined carefully to maintain integrity and a space will be
                created under the papilla by elevating it coronally.

        3. Preparation of L-PRF:

           L-PRF will be prepared according to Chaukroun's et al. 2001. Immediately prior to the
           surgery, 10 ml of blood (for each membrane) will be collected from the patient by
           venipuncture of antecubital vein and then drawn quickly into sterile glass tube with no
           anticoagulant and immediately centrifuged at 2700 rpm for 12 minutes at room temperature
           by using the Intra-Spin centrifuge (Intra-Lock).

           Then L-PRF clot will be removed by sterile tweezers and placed in Xpression™ kit for
           gentle compression by gravity. Then L-PRF will be ready to be used after 5 minutes (For
           group II, membranes will be sutured together before placement in the vertical incision).

        4. Placement and suturing of L-PRF in the recipient site:

           The L-PRF membrane will be trimmed to the desired shape and size and then placed under
           the papilla and mucogingival complex through the vertical incision to fill the black
           space.

           Then incision will be closed with 5-0 polypropylene simple interrupted sutures.

        5. Post operative management:

      It will include pain control using anti-inflammatory and analgesics (Brufen 600 mg) when
      needed and twice mouth rinse with chlorohexidine gluconate daily for one week.

      All Clinical and volumetric measurements will be carried out at baseline and after 6 months
      follow up and esthetic assessment will be done.

      Clinical assessment will be Plaque score index (PI), gingival score index (GI), papillary
      height from the tip of the papilla to mesial line angle, Nordland and Tarnaw classification.

      volumetric assessment will be with intraoral scan with CAD-CAM preoperative and 6 months
      postoperative.

      Esthetic assessment will be done by means of the root coverage esthetic score (RES), this
      score estimates five variables: gingival margin level (GM), the contour of the marginal
      tissue (MTC), soft tissue texture (STT), location of mucogingival junction (MGJ), and
      gingival color (GC). Zero, 3, or 6 points will be used for the estimation of the location of
      the gingival margin, while a score of 0 or 1 point will be used for each of the other
      variables.GM. Zero points = no root coverage (in which the gingival margin is in equal level
      to the baseline or migrated apically); 3 points = partial coverage; 6 points = Complete
      coverage.

      MTC. Zero points = asymmetrical gingival margin (does not track the CEJ); 1point =
      appropriate marginal contour/ scalloped gingival margin (tracks the CEJ).

      STT. Zero points = scar development; 1 point = absence of scar. MGJ. Zero points =MGJ is not
      uniform with the MGJ of neighboring teeth; 1 point = MGJ is uniform with the MGJ of
      neighboring teeth.

      GC. Zero points = tissue color differs from gingival color of neighboring teeth; 1 point =
      normal color and unification with the neighboring soft tissues.

      Accordingly, the perfect esthetic score is 10. Satisfaction questionnaire, to score degree of
      pain experienced during and after treatment and the degree of patient satisfaction with the
      cosmetic results of the procedure.

      All data will be collected blindly and subjected to statistical analysis.
    

Intervention name(s): interdental papilla reconstruction with L-PRF
Intervention type(s): Procedure
Intervention description(s): interdental papilla reconstruction with single layer of L-PRF versus multiple layers of L-PRF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: interdental papilla reconstruction; Leucocyte-Platelet Rich Fibrin (L-PRF)