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Completed

NCT Number: NCT03665272

The Evaluation of the Deepithelialized Gingival Graft Healing

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.

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Key information

Conditions

Wound Heal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zekeriya Taşdemir

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

deepithelialized gingival graft fixation

Procedure

one group's deepithelialized gingival graft fixed by sutures and other one's by tissue adhesive.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Evaluation of the Effects of Different Fixation Methods on Wound Healing After Deepithelialized Gingival Graft

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2018
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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