The Evaluation of the Deepithelialized Gingival Graft Healing

September 7, 2018 updated by: Zekeriya Tasdemir, TC Erciyes University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Melikgazi
      • Kayseri, Melikgazi, Turkey, 38039
        • Zekeriya Taşdemir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fixation by tissue adhesive
In this group, deepithelialized gingival grafts were fixed by tissue adhesive without any suture.
Procedure: deepithelialized gingival graft fixation
one group's deepithelialized gingival graft fixed by sutures and other one's by tissue adhesive.
Experimental: fixation by sutures
In this groups, deepithelialized gingival grafts were fixed by 4.0 round vicryl sutures.
Procedure: deepithelialized gingival graft fixation
one group's deepithelialized gingival graft fixed by sutures and other one's by tissue adhesive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measurements were performed at the day of surgery, 1, 3 and 7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measurements were performed at 1, 3 and 7 days post surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

September 3, 2018

Study Completion (Actual)

September 3, 2018

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Zeck

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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