The Evaluation of the Deepithelialized Gingival Graft Healing

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665272
• Other study ID #: Zeck
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: September 3, 2018

Study information

• Verified date: September 2018
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 3, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal

Intervention

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

Locations

Country	Name	City	State
Turkey	Zekeriya Tasdemir	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	deepithelialized gingival graft blood perfusion change	Blood perfusions (units) were measured by laser doppler flowmetry	measurements were performed at the day of surgery, 1, 3 and 7 days.
Secondary	Deepithelialized gingival graft recipient bed pain changes	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.