Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Evaluation of the Deepithelialized Gingival Graft Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03665272
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Zekeriya Tasdemir, TC Erciyes University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Wound Heal Procedure: deepithelialized gingival graft fixation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Different Fixation Methods on Wound Healing After Deepithelialized Gingival Graft
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : September 3, 2018
Actual Study Completion Date : September 3, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665272


Locations
Layout table for location information
Turkey
Zekeriya Taşdemir
Kayseri, Melikgazi, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Layout table for investigator information
Principal Investigator: zekeriya taşdemir, phd TC Erciyes University

Layout table for additonal information
Responsible Party: Zekeriya Tasdemir, Pricipal investigator, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03665272     History of Changes
Other Study ID Numbers: Zeck
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No