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

Universidad Complutense de Madrid

Status: Completed

Conditions: Mucogingival Deformity on Edentulous Ridge; Gingival Recession; Thin-gingiva

Treatments: Procedure: Simplified suture-less approach; Procedure: Application of hemostatic sponges and compressive sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT05381623

22/244-EC_X

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

1. Compromised general health status contraindicating the study procedures (≥ASA IV);
2. Drug abuse, alcohol abuse, or smoking > 10 cigarettes a day;
3. Chronic use of corticosteroids, NSAIDs, or immune-modulators (any type, any dose);
4. Use of anti-aggregant or anti-coagulant drugs;
5. Pregnant or nursing women;
6. Hypersensitivity to ibuprofen.

Local primary exclusion criteria:

1. History of previous soft tissue surgeries in the area of the harvest;
2. Preoperative evidence of a palate thickness < 2mm in the area of interest;
3. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Simplified suture-less approach

Experimental group

Description:

Infiltration of local anesthetic (articaine 4% 1:100.000 epinephrine) around the harvesting site and attendance for the establishment of a competent coagulum.

Treatment:

Procedure: Simplified suture-less approach

Conventional approach

Active Comparator group

Description:

Application of hemostatic sponges over the donor site and placement of tooth-suspended compressive sutures over the area.

Treatment:

Procedure: Application of hemostatic sponges and compressive sutures