The Effect of Ozone Therapy on Pain Perception After Free Gingival Graft Surgery in Patients With Mucogingival Defects
Condition: Open Wound of Palate Without Complication; Pain, Postoperative; Free Gingival Grafts; Mucogingival Defects; Gingival Recession; Donor Site; Patient Satisfaction
MeSH terms: Gingival Recession; Pain, Postoperative
Study type: Interventional

Summary: 
      Gaseous ozone (O3-triatomic oxygen) is the third-strongest oxidizing agent worldwide. It
      influences the cellular and the humoral immune system, by stimulating the proliferation of
      immunocompetent cells and the synthesis of immunoglobulin. Additionally; biologically active
      substances, such as interleukins, leukotrienes and prostaglandins which are beneficial in
      reducing inflammation and wound healing are orchestrated following ozone application. Given
      that after harvesting of a free gingival graft from the palatal donor site, healing occurs by
      secondary intention process; for patients with mucogingival conditions. The investigators
      will compare the natural process of healing at the donor site versus the healing process
      consecutive to ozone application; with the primary outcome is to evaluate the postoperative
      pain perception using visual analogue scale and to estimate the consumption of analgesics
      tablets after surgery.
    

Detailed description: 
      The procedures will be explained to all participants and they will be asked to sign an
      informed consent.

      All patients will receive oral hygiene instructions and will receive phase I therapy
      comprising supragingival scaling and subgingival debridement.

      After completion of phase I therapy the patients will be re-examined to ensure meeting all
      inclusion criteria. Then the participants will be allocated to 2 groups.

      Group I will receive ozone therapy after harvesting free gingival graft. Group II following
      the harvesting of the free gingival graft, will be protected by a periodontal pack.

      Surgical intervention:

      Graft harvesting at donor site (Sullivan, & Atkins, 1968) To prepare the donor area, a
      rectangular-shape incision with 1-1.5 mm thickness will be made, and care will be taken to
      place most of the coronal part of the incision at least 2 mm apical from gingival margins of
      the upper teeth. The apical coronal dimension of the graft.

      Following administration of anaesthesia by local infiltration (2% lidocaine with 1:100,000
      epinephrine), a template will be placed over the palatal mucosa and will be used to outline
      the dimensions of the graft. The area chosen to harvest the free gingival graft will be
      chosen between first premolar and first molar.

      The outlined graft will be carefully harvested as follows: The surgical blade entered in the
      contour incision, always in the posterior limit, sliding below the mucosa, and continued to
      find the opposite contour incision, in the anterior limit. The connective tissue surface will
      be carefully inspected for irregularities or adipose tissue after graft separation. Graft
      thickness will be immediately prepared (thinned) to obtain a graft approximately 1 to 1.5 mm
      thick.

      The palatal wound will be protected by a periodontal pack; for the control group.

      While the test group, will receive ozone therapy.

      Ozone Application Protocol:

      An ozone generator device (Ozone DTA-APOZAa- enterPrize Co9-Taiwan,R.0,C) with different
      probe numbers (#1 pointed probe,#2 pointed probe and #3 flat probe) will be used according to
      the manufacturer's instructions. Ozone will be applied on donor sites immediately after
      surgery and at days 1, 3, 7, 14 post-surgeries in the test group with output power at level
      6-12 for 1 minute.

      Ozone application in the control group will be simulated without starting the ozone
      generator.

      Postoperative Protocol:

      The participants will be instructed to abstain from brushing and flossing the teeth at the
      surgical area until suture removal (7days) and to use an antimicrobial rinse (0.12%
      chlorhexidine, 15 ml for 60 seconds twice daily) solution two times a day for 4 weeks.

      The participants will be also instructed to consume only soft foods during the first week and
      to avoid any other mechanical trauma to the treated sites.

      The participants will be given a prescription of Ibuprofen (600 mg every 12 hours) to be
      taken if necessary and the participants will be asked to record the number of tablets taken.

      Participants will be enrolled in a professional plaque control program weekly for the first 4
      weeks, then monthly until the end of the study.
    

Intervention name(s): Ozone generator device (Ozone DTA-APOZAa-enterprize CO9-Taiwan, R.0.C)
Intervention type(s): Device
Intervention description(s): Gaseous ozone ( O3-triatomic oxygen) activates the neuroprotective systems, improve the blood circulation, oxygen delivery, stimulate the immunocompetent cells and enhance the release of growth factors. Moreover, ozone therapy showed to increase the quality of life post-operatively to a free gingival graft harvesting and decrease post-operative pain sensation ( Tasdemir et al, 2016)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: Will receive ozone therapy after harvesting a free gingival graft. Group 2: Following the harvesting of the free gingival graft; the palatal donor site will be protected by a periodontal pack.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ozone; Therapy; Pain; Gingival; Palatal; Donor; site; Recession; Mucogingival; Defects; Free; Grafts