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

Not Applicable

Completed

• Conditions: Thin-gingiva; Mucogingival Deformity on Edentulous Ridge; Gingival Recession
• Interventions: Procedure: Simplified suture-less approach; Procedure: Application of hemostatic sponges and compressive sutures

• Registration Number: NCT05381623
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-19
• Study Start: 2022-05-20
• Primary Completion: 2022-06-14
• Study Completion: 2022-09-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simplified suture-less approach	Simplified suture-less approach	Infiltration of local anesthetic (articaine 4% 1:100.000 epinephrine) around the harvesting site and attendance for the establishment of a competent coagulum.
Conventional approach	Application of hemostatic sponges and compressive sutures	Application of hemostatic sponges over the donor site and placement of tooth-suspended compressive sutures over the area.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative bleeding	14 days after surgery	Occurrence of postoperative bleeding during the first two postoperative weeks reported by the patients through a dedicated questionnaire
Wound healing VAS at the donor site	7 days after surgery, 14 days after surgery, 30 days after surgery	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.
Patients related outcomes measures (PROMS)	14 days after surgery	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).
Patients consumption of analgesic rescue medication	14 days after surgery	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
Wound healing index at the donor site	7 days after surgery, 14 days after surgery, 30 days after surgery	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.

Trial Locations

Locations (1)

Department of Periodontology, University Complutense Madrid, Spain; 🇪🇸 Madrid, Spain