Different Platelet Concentrates After Gingivectomy and Gingivoplasty Evaluation of Its Effect on Early Wound Healing.
Condition: Wound Heal; Gingival Overgrowth; Gingival Enlargement; Platelet Rich Fibrin
MeSH terms: Gingival Overgrowth; Gingival Hyperplasia; Gingival Hypertrophy; Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of PRF, CGF and AFG application on early
      wound healing after gingivectomy and gingivoplasty operations. In the study designed split
      mouth, gingivectomy and gingivoplasty surgery were performed on 19 patients. The
      postoperative PRF, CGF, and AFG applied areas were compared with the control regions. 0th,7
      th,14 th and 28 th on the days, the surgical area was painted with mira-2-tone solution and
      evaluated in the ImageJ program. Measurements of clinical periodontal parameters including
      PI, GI, SC and SD were recorded at the beginning, after IPT and 28 days after the operation.
      Wound healing was evaluated with H2O2 test, VAS-Pain, and LTH index on 7th, 14th and 28th
      days. The patients were asked to evaluate their aesthetic perceptions on the VAS aesthetic
      scale.
    

Detailed description: 
      Study design and patient selection

      In this randomized, controlled, split-mouth (lower, upper jaw, right and left anterior
      regions) clinical study, who applied to İnönü University Faculty of Dentistry Department of
      Periodontology between January 2020 and May 2020, due to gingival problems, chronic
      examination was performed. included individuals diagnosed with inflammatory gingival
      enlargement.

      All patients received initial periodontal therapy (BPT). The patients were called for control
      after 2 weeks and surgery was planned for the patients who provided adequate oral hygiene. In
      our study, the vertical DM index, first described by Goaz and Angelopoulos, and later
      modified by Damm and Miller (DM), was used to classify the gingival enlargement in the
      vertical direction (1). In order to classify the bucco-lingual gingival growths in the
      interdental papillae, the horizontal MB index, first described by Seymour et al. And later
      modified by Miranda and Brunet (MB), was used (2). As a result of the measurements made,
      grades other than score 0 according to the DB and MB indices were accepted as having gingival
      enlargement. The distribution of control (n = 19) and three test groups (n = 19, n = 19, n =
      19) after gingivectomy and gingivoplasty was randomized (block randomization).

      Clinical Measurements

      In clinical periodontal evaluation, plaque index (PI) (3), gingival index (GI) (4), bleeding
      on probing (SC) and probing depth (SD ) measurements were performed at baseline (T0), after
      BPT (T1) and on the 28th day (T2) after gingivectomy and gingivoplasty operation.
      Measurements were made in a total of 6 regions of all teeth: mesio-buccal, mid-buccal,
      disto-buccal, disto-lingual / palatinal, mid-lingual / palatinal and mesio-lingual /
      palatinal. Clinical periodontal measurements of all teeth of the individuals included in the
      study were performed by a single investigator (E.B.).

      Gingivectomy and gingivoplasty

      Before surgery, all patients were gargled with 0.12% chlorhexidine for 1 minute. The incision
      lines were determined by applying infiltrative anesthesia (Maxicaine Fort) to the areas to be
      operated, and the external bevel incision was performed with a # 15 scalpel (Broche® Medical
      scalpel tip; carbon steel) and a Kirkland blade (Hu-Friedy, Chicago, IL, USA). Orban blade
      (Hu-Friedy, Chicago, IL, USA) was used in the interproximal areas. After the incision was
      completed, the remaining gum pieces were removed with the help of periodontal curette and
      microsurgical scissors (Hu-Friedy, Chicago, IL, USA). Then gingivoplasty was performed. After
      gingivectomy and gingivoplasty, the control areas were left to recover spontaneously. PRF,
      CGF and AFG were applied to the test areas. Surgical areas in control and test areas were
      covered with a periodontal pat (Coe-Pak, lsip, IL, USA).

      Preparation of platelet-rich fibrin membrane

      Blood taken from the antecubital veins of the patients was collected into 10 ml sterile
      glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain
      anticoagulants. The collected venous blood was placed in the PC-02 (Process, Nice, France)
      centrifuge device and centrifuged at 3000 rpm for 10 (400xg) minutes (5). The obtained PRF
      was taken out of the tube, placed in the PRF-BOX and turned into a membrane by compressing
      with light pressure for about 1 minute. The prepared PRF membranes were applied to the
      surgical operation area and the operation area was closed with a periodontal pat.

      Preparation of concentrated growth factor membrane

      Blood taken from the antecubital veins of the patients was collected into 10 ml sterile
      glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain
      anticoagulants. These tubes were then centrifuged in a centrifuge device (Medifuge;
      Silfradent srl, Sofia, Italy) using a program with the following features: acceleration for
      30 seconds followed by 2 minutes (692xg) at 2700 rpm, 4 minutes (547xg) at 2400 rpm, 2700
      rpm. Centrifugation for 4 minutes (592xg) at 3000 rpm for 3 minutes (855xg) and finally
      deceleration for 36 seconds (6). After centrifugation, CGF was taken from the middle part of
      the tube, placed in PRF-BOX and turned into a membrane by compressing with light pressure for
      about 1 minute. Prepared CGF membranes were applied to the surgical operation area and the
      operation area was closed with a periodontal pat.

      Preparation of autologous fibrin glue

      Venous blood taken from the patient was transferred to a 9 ml glass-covered plastic tube
      (Vacuette serum tubes, Greiner Bio-one) that did not contain any anticoagulants. Sohn et al.
      In the protocol he recommended (7), the venous blood collected in the tube was centrifuged in
      a centrifuge device (Medifuge, Silfradent, Italy) at 2700 rpm (approximately 692 g) for 2
      min. AFG obtained from the upper part of the tube after centrifugation was collected with the
      help of an injector and transferred to the metal body. The polymerization was allowed for
      15-20 minutes. After polymerization was completed, AFG was applied to the surgical operation
      area and the operation area was covered with a periodontal pat.

      Post Operative Care and Suggestion

      Patients were advised to protect the wound area with periodontal pats from trauma, not to
      consume too hot and too cold foods, and to eat soft foods. It was stated that the pat should
      be kept in the mouth for 1 week, and if the pat was damaged during this period, they should
      apply to our clinic immediately. Patients were prescribed paracetamol-containing analgesic
      (Parol 500 mg) and a mouthwash containing 0.12% chlorhexidine to use three times a day for a
      week. The patients were only advised not to brush their teeth in the operation area for 1
      week. It was stated that he should provide oral hygiene in areas that were not operated. They
      were advised to use an extra soft toothbrush in the area after the pat was removed.

      Surface area determination

      Mira-2-tone, a plaque staining agent (GMBH & Co., Duisburg, Germany), was used to detect
      wound surface epithelization at baseline, postoperative 7, 14, and 28 days. Standardized
      photographs were taken from each patient to evaluate the dark stained areas after staining
      with Mira-2-tone in the gingiva where epithelialization was not completed and wound healing
      continued. During the photo shoot, the patients were seated upright and facing straight
      ahead. All photos were taken by a single person on the same camera (Nikon Coolpix 4500,
      Tokyo, Japan), at the same distance (20 cm) and light values (ISO-800). The photo size was
      scaled by using a 10 mm Williams periodontal probe during the photo taking. Wound surface
      epithelization was calculated using Image J software program (National Institutes of Health,
      USA ImageJ 1.48V) from the photographs obtained. Each measurement step was done by the same
      researcher (E.B.) each time. The calibration of the person who made the measurements was
      performed by repeating the wound surface epithelialization area measurement at one-week
      intervals on the photo images of 10 patients who had undergone gingivectomy and gingivoplasty
      surgery and were not included in the study. In these two separate evaluations, the
      calculations were 95% compatible.

      Epithelialization test

      In order to evaluate the wound surface epithelization during the healing process, 3% H2O2 was
      applied to the surface of the operation area with the help of an injector. As a result of the
      decomposition of H2O2 into water and oxygen through the catalase enzyme released by the blood
      cells present in the wound area, it was evaluated as "epithelization incomplete" if foaming
      was observed with oxygen formation, and "epithelization completed" if foaming was not
      observed . H2O2 test was performed at the controls on the 7th, 14th and 28th days after the
      operation.

      Healing index Landry, Turnbull, and Howley (LTH) index, which classified the healing process
      according to wound surface redness, presence of bleeding, granulation tissue, epithelization,
      and suppuration (8). The wound healing process with LTH index was performed at the
      postoperative 7th, 14th and 28th days.

      Postoperative pain and aesthetic

      VAS was used for postoperative pain and aesthetic evaluation (9). The patient's 7th, 14th He
      was asked to evaluate the level of pain he felt from 1 to 10 according to the VAS-Pain (1:
      low pain, 10: severe pain) scale in the control sessions on the 28th and 28th days. In the
      control session on the 28th day, the patients were asked to evaluate their aesthetic
      perceptions from 1 to 10 according to the VAS-Aesthetics (1: dissatisfied, 10: very
      satisfied) scale.
    

Intervention name(s): Control group; PRF group; CGF group; AFG group
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The group that did not undergo any procedure after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied to the wound area.; The group in which PRF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA)was applied over the PRF.; The group in which CGF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the CGF.; The group in which AFG is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the AFG.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth design was used in the study. The chin was divided into lower, upper and right, and left anterior regions. The distribution of the platelet concentrate and control group to be used after gingivectomy and gingivoplasty was randomly decided.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Autologous fibrin glue; Concentrated growth factor; Gingivectomy; Gingivoplasty; Platelet rich fibrin