Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Gingival thickness plays a key role not only in the etiology but also in the treatment of
      gingival recessions. a thin marginal tissue lining the hard periodontal tissues seems to be
      one of the main risk factor for the onset of gingival recession ; more recently, authors
      reported that as the gingival thickness decreases, the gingival recession severity increases
      . When gingival inflammation occurs, if the tissue is thin the consequent destruction can
      quickly produce a gingival recession (GR) .

      When treating a gingival recession, the clinician should aim not only to completely cover the
      exposed root surface but also to prevent a future recession recurrence Currently, CAF
      associated with graft is considered as the gold standard for exposed root coverage; this
      technique has demonstrated high rates in gingival recession reduction and positive
      predictability in obtaining complete root coverage . However, some disadvantages about this
      surgical approach can be easily highlighted: patients experience more discomfort, longer
      chair-time it's necessary and a second wound area is created . On the other hand, CAF
      procedure alone does not require a second surgical site, with better post-operative course,
      also reducing the surgical time. However, long term-studies report lower probability of
      complete root coverage when using the CAF technique without a simultaneous increase of the
      gingival thickness as compared to CAF+graft treatment.

      In this scenario, The Platelet rich fibrin (PRF) could be a valuable alternative treatment of
      gingival defects. It's a platelet concentrate, obtained by a fast and simple procedure that
      does not require anticoagulant and bovine thrombin . It can also be categorized as a live
      tissue thanks to platelets, leukocytes, growth factors and stem cells trapped in a
      polymerized fibrin mesh. PRF is used in various fields of regenerative medicine; It promotes
      stabilization and revascularization of the flaps, contributes to soft tissue wound healing
      and reduces post-operative discomfort.

      The purpose of this clinical study will be to determine if the combination of platelet rich
      fibrine membrane with a modified coronally advanced flap (MCAF) improved the gingival biotype
      compared to CAF + graft or CAF alone.
    

Detailed description: 
      This prospective, randomized and controlled clinical trial will compare three modalities of
      treatment of Miller's class I-II recession: CAF with PRF versus CAF with Sub-epithelial
      tissue graft (SCTG) versus CAF. From each patient a single recession on a single tooth
      located in the upper arches will be selected. Clinical parameters will be evaluated at
      base-line and after 6 months.

      The protocol is approved by the "G. D'Annunzio" University Ethical Committee. This study is
      in accordance with the Declaration of Helsinki of 1975. Patients will be recruited from the
      Unit of Periodontology, Department of Medical, Oral and Biotechnological Sciences, "G.
      D'Annunzio" University of Chieti-Pescara, Italy. All the volunteer candidates will sign a
      written informed consent.

      The trial director will be responsible for randomly assigning patients to treatment after
      enrollment and will not involve with the clinical interventions or the study measurements. A
      computer-generated table will be used to make the random assignment, known only to the trial
      director. An opaque envelope will conceal group allocation and will be opened just before the
      intervention surgery. Matching between group and treatment will be performed by a figure
      extraneous to the experimentation, responsible even for keeping and breaking the blinding,
      and known only to him.

      Patients and examiners will be masked to group membership; clinical examiners will be blinded
      to each other. The study analyst will be also blind to group membership. The analyst will
      receive the data by groups labeled as A and B. The blind will not be broken until after study
      completion.

      At baseline and 6 months after surgery, the following clinical measurements will be recorded
      on the mid-buccal point of exposed root surface: Gingival thickness (GT) will be determined
      using a stent at a mid-buccal location about 1 mm apical to the pocket depth (PD) level with
      a #15 endodontic reamer with a silicon disk stop. The soft tissue will be gently pierced at a
      90° angle, until hard tissue will be felt. Once the silicon disk will be in contact with the
      soft tissue surface, it will be fixed by a drop of cyanoacrylate adhesive. After the careful
      removal of the reamer, the distance between the reamer tip and the stop will be measured with
      a calliper accurate to the nearest 0.1 mm. The other measurements will be taken with a
      periodontal probe and will be recorded to the nearest millimetre as follows: Gingival
      recession (GR) will be measured as the distance from the cement-enamel junction (CEJ) to the
      mid-buccal point of the gingival margin. PD and Clinical attachment level (CAL) will be
      measured as the distance between the bottom of the pocket and the gingival margin and CEJ,
      respectively. Keratinized tissue (KT) will be recorded from the mid-buccal point of the
      gingival margin to the mucogingival junction.

      Patient morbidity will be evaluated with a visual analogue scale (VAS). Root coverage
      esthetic score (RES) (Cairo et al., 2009) will be used for assessing aesthetic outcomes of
      root coverage procedures.

      All clinical parameters will be measured by the same investigator. To avoid a calibration
      probing bias, 60 recession defects will be measured twice within 72 hours. When 90% of the
      measurements of Gingival thickness will be within 0.3 mm and within 0.5 mm for measurements
      of GR , calibration will be successfully accepted.

      30 ml of blood samples will be collected in 10-ml tubes without anticoagulant and promptly
      centrifuged at 3,000 revolutions per minute for 10 minutes. The acellular plasma formed in
      the upper layer will be washed out. The clot, positioned in the middle of the vial, will be
      cut off from the lower red corpuscles part. Each PRF clot will be folded onto itself in order
      to double the thickness, and two membranes placed one over the other (quadruple L-PRF layer)
      represented the L-PRF graft.

      The connective tissue graft will be harvested from the palatal area on the opposite side of
      the gingival defect according to Zucchelli et al12. Briefly, two horizontal and two vertical
      incisions will delimitate the donor area. The graft will be separated from the underlying
      tissues by the scalpel's blade oriented parallel to the palatal surface to obtain an about 2
      mm thick graft. Then, the graft will be de-epithelialized by a 15c blade and the fatty tissue
      will be eliminated until obtaining a graft with a thickness of about 1,5 mm. measured by a
      standard caliper.

      Exposed and intrasulcular root surface will be accurately scaled using curettes. A modified
      coronally advanced flap technique (MCAF) will be used to treat the recession defect. The ﬂap
      will be elevated as follows: an intrasulcular incision will be performed around the selected
      tooth, the incision moves on contiguous papillae area, avoiding the gingival margin of
      adjacent teeth. From each side, from coronal to apical, an oblique incision will be carried
      out. A split-full-split dissection will be undertaken until the CEJ could be passively cover
      by the flap. Both papillae will be de-epithelialized. The PRFs and the SCTGs will be placed
      over the exposed root surface of the Test group and Control 1 group respectively. The
      gingival defect will be fully lined by grafts that mildly cover the neighbouring sub-papillae
      areas. The grafts will be fixed applying suture to the periosteum below. In each group, ﬂap
      will be coronally positioned and sutured over the enamel in a tension-free position.

      All patients will receive 2 g/day amoxicillin+clavulanic acid for 6 days for post-operative
      infection prevention; 400 mg of oral ibuprofen, twice daily, will control the pain; 0.12%
      chlorhexidine rinses, twice daily for 3 weeks, will be prescribe to the patients. Sutures
      will be removed after 14 days. Only 2-4 weeks after sutures removal, respectively, cautious
      brushing by a soft toothbrush and interdental brushing will be recommend; meantime, the
      patients use a 1% chlorhexidine gel twice daily. Weekly supra-gingival professional hygiene
      and motivational reinforcement will be administer to the patients for 6 weeks.
    

Intervention name(s): PRF+CAF treated patients; SCTG+ CAF treated patients; CAF treated patients
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Patients will be treated by coronally advanced flap with addition of PRF membrane; Patients will be treated by coronally advanced flap with addition of SCTG graft; Patients will be treated by coronally advanced flap
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Platelet-Rich fibrin; Plastic surgery; Phenotype