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

NCT05381623 | Completed

• 1 other identifier: 22/244-EC_X
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Connective tissue graft; Free gingival graft; Mucogingival surgery; Mucogingival conditions; Gingival Recession

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative bleeding

  14 days after surgery

• Patients related outcomes measures (PROMS)

  14 days after surgery

• Patients consumption of analgesic rescue medication

  14 days after surgery

• Wound healing index at the donor site

  7 days after surgery, 14 days after surgery, 30 days after surgery

• Wound healing VAS at the donor site

  7 days after surgery, 14 days after surgery, 30 days after surgery

Study Arms (2)

Simplified suture-less approach

EXPERIMENTAL

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

Conventional approach

ACTIVE COMPARATOR

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

Interventions

Simplified suture-less approach PROCEDURE

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.

Simplified suture-less approach

Application of hemostatic sponges and compressive sutures PROCEDURE

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.

Conventional approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;
• a. Non compliant patients: poor oral hygiene (FMPS \>20%) at 2 consecutive visits.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Department of Periodontology, University Complutense Madrid, Spain

Madrid, 28040, Spain

Location

Related Publications (8)

• 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.

  PMID: 24600654 RESULT

• 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.

  PMID: 16253095 RESULT

• 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.

  PMID: 28976050 RESULT

• 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.

  PMID: 29915931 RESULT

• 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.

  PMID: 30395825 RESULT

• 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.

  PMID: 30690733 RESULT

• 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.

  PMID: 20590963 RESULT

• 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.

  PMID: 31461778 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Mariano Sanz Alonso

  Faculty of Odontology, University Complutense, Madrid, Spain

  STUDY CHAIR

• David Palombo

  Faculty of Odontology, University Complutense, Madrid, Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Allocation to the test or control group will be revealed to the surgeon only after completing the harvest of the free gingival graft.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 19, 2022
• Study Start: May 20, 2022
• Primary Completion: June 14, 2022
• Study Completion: September 30, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)