The Effectiveness of Different Methods for Healing a Palatal Donor Site
Condition: Wound Heal; Graft Pain; Palate; Wound
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Postoperative complications associated with free gingival graft (FGG) procedures are
      prolonged bleeding from the donor site, postoperative pain and delayed wound healing which
      increases the patients' morbidity. Hence, the aim of this study is to assess the
      effectiveness of different treatment modalities on palatal wound healing and patient's
      morbidity after FGG. Ninety patients requiring FGG were randomly will be assigned into six
      groups: group 1: Platelet rich fibrin (PRF) membrane, group 2: Essix retainer, group 3:
      topical ozone therapy, group 4: low-level laser therapy (LLLT), group 5: collagen fleece and
      group 6: untreated control group. Epithelization will be evaluated by means of bubble
      formation; sensitivity, edema, pain, changes in eating habits and burning sensation will be
      assessed by using visual analog scale (VAS) and also the presence of discomfort and bleeding
      will be evaluated in the postoperative first week and at 14 days, 1 and 3 months
      postoperatively.
    

Detailed description: 
      Inadequate attached gingiva is one of the major mucogingival problems for many individuals.
      However, the width of the keratinized tissue required to prevent periodontal disease remains
      unclear. Recently, a consensus report highlighted that if an individual's plaque control is
      suboptimal, a minimum of 2 mm of keratinized tissue and 1 mm of attached gingiva is needed.

      Palatal keratinized mucosa is the most favorable donor region for a free gingival graft (FGG)
      due to its anatomic properties such as being histologically identical to keratinized attached
      mucosa of alveolar ridge and its ideal tissue thickness. The FGG surgical wound heals within
      2-4 weeks, and prolonged bleeding, pain, and delayed wound healing of either the donor or
      recipient sites, which increases the patient's risk of morbidity, are the most common
      postoperative complications following surgery. Although homeostatic agents, mechanical
      barriers, and bioactive materials have been found to be effective in preventing these
      complications, the most ideal treatment has not yet been determined.

      Platelet-rich fibrin (PRF), a platelet concentrate, is a safe and cost-effectiveness
      procedure that does not require biochemical blood handling. PRF has been used in many fields
      as an autologous biomaterial with a great healing potential for regenerating soft tissue and
      bones without inflammatory reactions, and it may be used to promote hemostasis and wound
      healing due to the presence of many growth factors. Recent studies have concluded that using
      PRF membranes after harvesting FGG enhances wound healing, reduces a patient's discomfort,
      and decreases need to change eating habits; thus, it reduces patient morbidity.

      An Essix® retainer (Clear Advantage Series, Ortho Technology, Florida, USA) is a
      thermoplastic material used for stabilization after orthodontic treatment. It has been
      reported that gingival wounds that heal by secondary intention should be sheltered during the
      period of epithelization to protect against topical irritants, trauma, acidic or highly
      seasoned foods, and toothbrush abrasion.

      It has been suggested that hemostatic agents provide faster and continuous hemostasis and
      make a positive contribution to early soft tissue healing. Application of hemostatic agents
      to the palatal donor sites has been found to be highly beneficial for achieving hemostasis in
      comparison to pressure only. Collagen fleece is a hemostatic agent that is made from the
      natural collagen of porcine dermis. The structure of the collagen promotes the formation and
      stabilization of blood clots during the initial wound healing phase. Recently, collagen-based
      materials have been used to improve early wound healing with an open healing design in the
      palatal area.

      Ozone is a natural gaseous molecule made up of three oxygen atoms. The use of ozone has been
      proposed in dentistry because of its a strong oxidation effect and its antimicrobial
      potential, biocompatibility, and healing properties. In a previous study, the application of
      ozonated oil was reported to improve epithelial healing and gingival health following topical
      application. Taşdemir et al. concluded that ozone therapy could enhance wound healing, and
      the patients receiving this therapy experienced less pain after FGG operations than patients
      that had not received it.

      Lower-level laser therapy (LLLT) is known as 'soft laser therapy' or 'bio-stimulation'. In
      dentistry, LLLT is usually used to accelerate wound healing, enhance remodeling and repair of
      bone, and reduce pain. Application of LLLT has been shown to improve wound healing after FGG
      and gingivectomy.

      In light of this aforementioned information, it has been hypothesized that applications of
      PRF, an Essix retainer, collagen fleece, ozone therapy, and LLLT can result in improved wound
      healing after harvesting FGG in comparison to spontaneous healing. Thus, the present study
      aimed to assess and compare the effectiveness of these methods on palatal wound healing and
      patient morbidity.
    

Intervention name(s): PRF; Essix retainer; Ozone therapy; LLLT; Collagen fleece
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Applying to the palatal wounds; Applying to the palatal wounds; Applying to the palatal wounds; Applying to the palatal wounds; Applying to the palatal wounds
Other intervention name(s): medical device; medical device; medical device; medical device; medical device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Graft; Pain; Palate; Wound healing