Clinical trial NCT05381623: Harvest of Free Gingival Grafts With or Without the Application of Hemostatic Sutures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thin-gingiva
Mucogingival Deformity on Edentulous Ridge
Gingival Recession
Keywords: Connective tissue graft
Free gingival graft
Mucogingival surgery
Mucogingival conditions
Gingival Recession
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Palatal microvascular healing
timeFrame: before surgery, 3 days after surgery, 7 days after surgery, 14 days after surgery, 30 days after surgery
Secondary outcomes:
measure: Postoperative bleeding
timeFrame: 14 days after surgery
measure: Patients related outcomes measures (PROMS)
timeFrame: 14 days after surgery
measure: Patients consumption of analgesic rescue medication
timeFrame: 14 days after surgery
measure: Wound healing index at the donor site
timeFrame: 7 days after surgery, 14 days after surgery, 30 days after surgery
measure: Wound healing VAS at the donor site
timeFrame: 7 days after surgery, 14 days after surgery, 30 days after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Department of Periodontology, University Complutense Madrid, Spain
Study officials:
affiliation: Faculty of Odontology, University Complutense, Madrid, Spain
name: Mariano Sanz Alonso
role: STUDY_CHAIR
affiliation: Faculty of Odontology, University Complutense, Madrid, Spain
name: David Palombo
role: STUDY_DIRECTOR
References:
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citation: Molnar E, Fazekas R, Lohinai Z, Toth Z, Vag J. Assessment of the test-retest reliability of human gingival blood flow measurements by Laser Speckle Contrast Imaging in a healthy cohort. Microcirculation. 2018 Feb;25(2). doi: 10.1111/micc.12420.
citation: Sanz-Martin I, Rojo E, Maldonado E, Stroppa G, Nart J, Sanz M. Structural and histological differences between connective tissue grafts harvested from the lateral palatal mucosa or from the tuberosity area. Clin Oral Investig. 2019 Feb;23(2):957-964. doi: 10.1007/s00784-018-2516-9. Epub 2018 Jun 18.
citation: Tavelli L, Barootchi S, Ravida A, Oh TJ, Wang HL. What Is the Safety Zone for Palatal Soft Tissue Graft Harvesting Based on the Locations of the Greater Palatine Artery and Foramen? A Systematic Review. J Oral Maxillofac Surg. 2019 Feb;77(2):271.e1-271.e9. doi: 10.1016/j.joms.2018.10.002. Epub 2018 Oct 11.
citation: Tavelli L, Barootchi S, Greenwell H, Wang HL. Is a soft tissue graft harvested from the maxillary tuberosity the approach of choice in an isolated site? J Periodontol. 2019 Aug;90(8):821-825. doi: 10.1002/JPER.18-0615. Epub 2019 Feb 12.
citation: Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
citation: Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.