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

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

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).

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Department of Periodontology, University Complutense Madrid, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Simplified suture-less approach; 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.
Active Comparator: Conventional approach; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Study Chair: Mariano Sanz Alonso, Faculty of Odontology, University Complutense, Madrid, Spain; Study Director: David Palombo, Faculty of Odontology, University Complutense, Madrid, Spain

Publications and helpful links

General Publications

• 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.
• 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.
• Dellavia C, Ricci G, Pettinari L, Allievi C, Grizzi F, Gagliano N. Human palatal and tuberosity mucosa as donor sites for ridge augmentation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):179-86. doi: 10.11607/prd.1929.
• Huang LH, Neiva RE, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedure. J Periodontol. 2005 Oct;76(10):1729-34. doi: 10.1902/jop.2005.76.10.1729.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Gingival Recession; Connective tissue graft; Free gingival graft; Mucogingival surgery; Mucogingival conditions
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession; Coagulants; Hemostatics
• Other Study ID Numbers: 22/244-EC_X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No