The Evaluation of the Deepithelialized Gingival Graft Healing

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Procedure: deepithelialized gingival graft fixation

• Registration Number: NCT03665272
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-01-10
• Status Verified: 2018-09
• Primary Completion: 2018-09-03
• Study Completion: 2018-09-03
• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Study First Posted: 2018-09-11
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fixation by tissue adhesive	deepithelialized gingival graft fixation	In this group, deepithelialized gingival grafts were fixed by tissue adhesive without any suture.
fixation by sutures	deepithelialized gingival graft fixation	In this groups, deepithelialized gingival grafts were fixed by 4.0 round vicryl sutures.

Primary Outcome Measures

Name	Time	Method
deepithelialized gingival graft blood perfusion change	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

Name	Time	Method
Deepithelialized gingival graft recipient bed pain changes	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

Trial Locations

Locations (1)

Zekeriya Taşdemir; 🇹🇷 Kayseri, Melikgazi, Turkey