Laser Bandage and Surgical Stent as Palatal Donor Site Dressing After Free Gingival Graft Surgery.
Condition: Palate; Wound
Study type: Interventional

Summary: 
      The free gingival graft (FGG) procedure is a harvesting technique that creates an open wound
      that heals by secondary intention. Retarded wound healing, excessive bleeding, and
      postoperative pain have been reported after FGG procedures. Hemostatic agents include ferric
      sub-sulfate solution, absorbable synthetic collagen, absorbable gelatin sponge, or oxidized
      regenerated cellulose. The agents are often combined with a surgical stent designed to cover
      the donor site, providing protection and pressure hemostasis. Diode laser also exhibits
      excellent thermal effects with deep tissue penetrative properties, to enhance coagulation.
      Laser Bandage (LB) could also enhance wound healing and reduce subjective postoperative
      complications in the palatal donor area after harvesting FGG similarly.
    

Detailed description: 
      NEED FOR THE STUDY Autogenous soft tissue grafts are widely used to increase the width of
      keratinized tissue.1 The free gingival graft (FGG) procedure is a harvesting technique that
      creates an open wound that heals by secondary intention. Retarded wound healing, excessive
      bleeding, and postoperative pain have been reported after FGG procedures. To overcome these
      problems, several techniques and products have been developed. Hemostatic agents such as
      ferric sub-sulfate solution, absorbable synthetic collagen, absorbable gelatin sponge, or
      oxidized regenerated cellulose. The agents are often combined with a surgical stent designed
      to cover the donor site, providing protection and pressure hemostasis. However, these
      materials may cause adverse effects such as allergies or foreign body reactions or retarded
      healing of the wound. An optimal method to reduce patient morbidity and enhance early wound
      healing in the palatal donor site has not yet been defined. Therefore, obtaining new
      materials that provide better wound care by decreasing bacterial contamination and enhancing
      wound healing has been considered an essential demand.

      Recently, Lasers are also considered a good choice for wound coverage of the donor site due
      to effective tissue ablation, and hemostatic and bactericidal effects. Laser exhibits
      hemostatic effects due to its 'hot-tip' effect caused by heat accumulation at the end of the
      fibre. This produces a thick coagulation layer called a laser bandage or biological bandage.
      It is also referred to as the 'char layer' or 'eschar on the treated surface. Coleton placed
      a biological bandage in the donor site using C02 Laser, set at 5W continuous wave in ablative
      mode. Low and Convissar used erbium laser settings of low wattage with no water, some air and
      few pulses per second to create laser bandage to achieve coagulation. Since Diode laser also
      exhibits excellent thermal effects with deep tissue penetrative properties, it enhances
      coagulation. the investigator proposes Laser Bandage (LB) could also enhance wound healing
      and reduces subjective postoperative complications in the palatal donor area after harvesting
      FGG in a similar way.

      To date, no studies have evaluated and compared if the diode laser bandage method is more
      effective than other palatal wound protection methods. Hence, the current study which is
      first of a kind is undertaken with the objectives of evaluating the effectiveness of Diode LB
      in achieving donor site hemostasis and comparing wound healing with a standardized palatal
      haemostatic agent in gel form with the surgical stent in a randomized controlled fashion.
    

Intervention name(s): Laser Bandage; Hemostatic agent with surgical stent
Intervention type(s): Device; Procedure
Intervention description(s): The Diode Laser will create a biological bandage at a wavelength of 810 nm, set at 5W in continuous-wave mode, applied via a 400-µm optical fibre.; Following graft harvesting, the donor site was secured with a hemostatic agent and protected with a palatal stent
Other intervention name(s): Diode laser (A.R.C- Fox); Abgel with surgical stent
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LASER BANDAGE; WOUND HEALING