Harvest of Free Gingival Grafts With or Without the Application of Hemostatic Sutures

Study Overview
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Brief Summary
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Randomized, single-center trial with 2 parallel arms and a 1:1 allocation ratio, with the aim of comparing clinical and microvascular healing and patients related outcomes, which follow the harvest of a free gingival graft, where hemostasis has been achieved with either compressive sutures and homeostatic sponges (control) or with a simplified suture-less approach (test).

Detailed Description
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This randomized two parallel arms controlled clinical trial aims to establish the early microvascular healing, clinical healing, and patients related outcomes, which follow the harvest of a free gingival graft, where hemostasis has been achieved with either compressive sutures and homeostatic sponges (control) or with a simplified suture-less approach (test). The primary outcome is the microvascular healing of the palate14 days after surgery, assessed by measuring the palatal blood flow with a Laser Speckle Contrast Imaging (LSI), expressed in Laser Speckle Perfusion Units (LSPU). Secondary outcomes include the palatal blood flow at 3, 7 and 30 days after surgery, the clinical healing of the palate, the occurrence of postoperative bleeding and patients related outcome measures assessed 14 postoperative days. A figure of 16 subjects per group was obtained based on an expected difference of 7 LSPU, considering a SD of 6.3 SLPU, 80% power, alpha 0.05, and assuming a foreseen drop-out rate of 15%. Patients will be randomly allocated to two groups: test (simplified suture-less approach) and control (compressive sutures and homeostatic sponges). Cases will be the unit of analysis and T-student (normal distribution) or U Mann Whitney (non normal distribution or non parametric variables) will be performed setting the significance level at p < 0.05.

Official Title
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Microvascular Response to the Harvest of Free Gingival Grafts With or Without the Application of Hemostatic Sutures: a Randomized Controlled Clinical Trial Assessing Palatal Blood Flow by Laser Speckle Contrast Imaging

Conditions
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Thin-gingiva, Mucogingival Deformity on Edentulous Ridge, Gingival Recession

Intervention / Treatment
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* Procedure: Simplified suture-less approach
* Procedure: Application of hemostatic sponges and compressive sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult (≥ 18 year old), male or female patient from the University Complutense of Madrid, being able to sign an informed consent form, presenting any mucogingival condition requiring the placement of a free gingival graft or a connective tissue graft obtained through the extra oral de-epithelialization of a free gingival graft. Exclusion Criteria: Patients fitting to all the above inclusion criteria will be excluded from the study if unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria will be found at any time through the study: Systemic primary exclusion criteria: Compromised general health status contraindicating the study procedures (≥ASA IV); Drug abuse, alcohol abuse, or smoking > 10 cigarettes a day; Chronic use of corticosteroids, NSAIDs, or immune-modulators (any type, any dose); Use of anti-aggregant or anti-coagulant drugs; Pregnant or nursing women; Hypersensitivity to ibuprofen. Local primary exclusion criteria: History of previous soft tissue surgeries in the area of the harvest; Preoperative evidence of a palate thickness < 2mm in the area of interest; Intraoperative evidence of active bleeding from the harvesting site at the end of surgery, which impedes the stabilisation of a good coagulum over the harvesting area; Secondary exclusion criteria: a. Non compliant patients: poor oral hygiene (FMPS >20%) at 2 consecutive visits.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simplified suture-less approach<br>Infiltration of local anesthetic (articaine 4% 1:100.000 epinephrine) around the harvesting site and attendance for the establishment of a competent coagulum. | Procedure: Simplified suture-less approach<br>* Immediately after the harvest of a free gingival graft from hard palate, at least a half carpule of local anesthetic (articaine 4% 1:100.000 epinephrine) will be infiltrated within the apical border of the harvesting site and another half mesially and distally to the harvesting site. At the end of the mucogingival procedure, the donor site will be evaluated to inquire regarding the presence of a competent coagulum over the wound area. In such a case, no additional procedure will be performed at the recipient site.<br>|
| Active Comparator: Conventional approach<br>Application of hemostatic sponges over the donor site and placement of tooth-suspended compressive sutures over the area. | Procedure: Application of hemostatic sponges and compressive sutures<br>* Immediately after the harvest of a free gingival graft from hard palate, hemostatic collagen sponges will be applied over the harvesting site and a series of tooth suspended external mattress sutures (PGA 5/0) will be applied over the area, in order to provide a compressive effect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatal microvascular healing | Changes in the palatal blood flow measured with Laser Speckle Contrast Imaging (LSI), expressed in Laser Speckle Perfusion Units (LSPU) | before surgery, 3 days after surgery, 7 days after surgery, 14 days after surgery, 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative bleeding | Occurrence of postoperative bleeding during the first two postoperative weeks reported by the patients through a dedicated questionnaire | 14 days after surgery | 
| Patients related outcomes measures (PROMS) | Patients pain and discomfort with respect to the procedure will be evaluated during the first 2 postoperative weeks with a dedicated questionnaire, utilising VAS scales ranging from 0 (no pain) to 10 (maximum pain). | 14 days after surgery | 
| Patients consumption of analgesic rescue medication | Patients will be asked to report the amount of rescue medication (ibuprofen 600mg) that have assumed for pain control every day during the first 2 postoperative weeks | 14 days after surgery | 
| Wound healing index at the donor site | Healing at the donor site will be evaluated at 7, 14 and 30 days after the surgery with the wound healing index (WHI) (Huang et al. 2005), using the following criteria: score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence; score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration; and score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration. Scoring will be performed by two independent investigators (DP & AD) over clinical pictures. | 7 days after surgery, 14 days after surgery, 30 days after surgery | 
| Wound healing VAS at the donor site | Healing will be assessed with a VAS scale, scoring 0 in case of evident tissue necrosis and 10 in case of uneventful healing with no signs of edema or erythema. Scoring will be performed by two independent investigators (DP & AD) over clinical pictures. | 7 days after surgery, 14 days after surgery, 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Connective tissue graft, Free gingival graft, Mucogingival surgery, Mucogingival conditions, Gingival Recession