The Evaluation of the Deepithelialized Gingival Graft Healing

Overview

The aim of this study was to compare of the effects of different fixation methods on deepithelialized gingival graft wound healing. Laser doppler flowmetry method was used to determine for blood perfusion changes. 40 patients were devided into two groups randomly and deepithelialized gingival graft procedure was performed and healings were evaluated by laser doppler flowmetry.

Full Title of Study: “Evaluation of the Effects of Different Fixation Methods on Wound Healing After Deepithelialized Gingival Graft”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 3, 2018

Detailed Description

This study evaluates the effects of different fixation methods on the early healing period of deepithelialized gingival grafts placed for non-root coverage gingival augmentation by laser Doppler flowmetry Forty patients were assigned to study groups: 1)test : tissue adhesive or 2) control group: suture. Forty patients completed the study. Blood perfusion in the recipient site was measured by laser doppler flowmetry on the day of surgery and at 3 and 7 days after surgery. Quality of life and pain at recipient sites were also investigated.

Interventions

  • Procedure: deepithelialized gingival graft fixation
    • one group’s deepithelialized gingival graft fixed by sutures and other one’s by tissue adhesive.

Arms, Groups and Cohorts

  • Experimental: fixation by tissue adhesive
    • In this group, deepithelialized gingival grafts were fixed by tissue adhesive without any suture.
  • Experimental: fixation by sutures
    • In this groups, deepithelialized gingival grafts were fixed by 4.0 round vicryl sutures.

Clinical Trial Outcome Measures

Primary Measures

  • deepithelialized gingival graft blood perfusion change
    • Time Frame: measurements were performed at the day of surgery, 1, 3 and 7 days.
    • Blood perfusions (units) were measured by laser doppler flowmetry

Secondary Measures

  • Deepithelialized gingival graft recipient bed pain changes
    • Time Frame: measurements were performed at 1, 3 and 7 days post surgery.
    • In this evaluations, we did not evaluate the total range we used subscale pain evaluation by visual analog scale. visual analog scale consisted of 10 units,in combination with a graphic rating scale.On the visual analog scale,the left and right end of the graphic represented the absence of pain (minimum 0)(score 0) and the most severe pain (maximum 10) (score 10),respectively. Patients were warned to complete the visual analog scale taking into consideration the intensity of their pain in the previous 24 hours on all recall days

Participating in This Clinical Trial

Inclusion Criteria

  • 18 to 65 years of age – systemically healthy – inadequate amount or absence of keratinized gingiva on the labial side of the lower incisor region – no restorations on the lower incisor region – no mucogingival surgical history in the lower incisor region – no periodontal treatment within the previous year – no systemic antibiotics taken for 6 months before the study – not pregnant or lactating – no-smoking Exclusion Criteria:

  • lower 18 and upper than 65 years of age – systemical disease – adequate amount of keratinized gingiva on the labial side of the lower incisor region – restorations on the lower incisor region – mucogingival surgical history in the lower incisor region – periodontal treatment within the previous year – systemic antibiotics taken for ‡6months before the study – pregnancy or lactating – smoking history or current smokers

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • TC Erciyes University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zekeriya Tasdemir, Pricipal investigator – TC Erciyes University
  • Overall Official(s)
    • zekeriya taşdemir, phd, Principal Investigator, TC Erciyes University

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