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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Simplified suture-less approach

Application of hemostatic sponges and compressive sutures

About this trial

This is an interventional treatment trial for Thin-gingiva focused on measuring Connective tissue graft, Free gingival graft, Mucogingival surgery, Mucogingival conditions, Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

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.

Local primary exclusion criteria:

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;

Secondary exclusion criteria:

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

Sites / Locations

Department of Periodontology, University Complutense Madrid, Spain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simplified suture-less approach

Conventional approach

Arm Description

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

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

Outcomes

Primary Outcome Measures

Palatal microvascular healing

Changes in the palatal blood flow measured with Laser Speckle Contrast Imaging (LSI), expressed in Laser Speckle Perfusion Units (LSPU)

Secondary Outcome Measures

Postoperative bleeding

Occurrence of postoperative bleeding during the first two postoperative weeks reported by the patients through a dedicated questionnaire

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).

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

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.

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.

Full Information

NCT ID

NCT05381623

First Posted

May 13, 2022

Last Updated

October 3, 2023

Sponsor

Universidad Complutense de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT05381623

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

May 20, 2022 (Actual)

Primary Completion Date

June 14, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Masking Description

Allocation to the test or control group will be revealed to the surgeon only after completing the harvest of the free gingival graft.

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simplified suture-less approach

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional approach

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Simplified suture-less approach

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Application of hemostatic sponges and compressive sutures

Intervention Description

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.

Primary Outcome Measure Information:

Title

Palatal microvascular healing

Description

Changes in the palatal blood flow measured with Laser Speckle Contrast Imaging (LSI), expressed in Laser Speckle Perfusion Units (LSPU)

Time Frame

before surgery, 3 days after surgery, 7 days after surgery, 14 days after surgery, 30 days after surgery

Secondary Outcome Measure Information:

Title

Postoperative bleeding

Description

Occurrence of postoperative bleeding during the first two postoperative weeks reported by the patients through a dedicated questionnaire

Time Frame

14 days after surgery

Title

Patients related outcomes measures (PROMS)

Description

Time Frame

14 days after surgery

Title

Patients consumption of analgesic rescue medication

Description

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

Time Frame

14 days after surgery

Title

Wound healing index at the donor site

Description

Time Frame

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

Title

Wound healing VAS at the donor site

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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. Local primary exclusion criteria: 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; Secondary exclusion criteria: a. Non compliant patients: poor oral hygiene (FMPS >20%) at 2 consecutive visits.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mariano Sanz Alonso

Organizational Affiliation

Faculty of Odontology, University Complutense, Madrid, Spain

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

David Palombo

Organizational Affiliation

Faculty of Odontology, University Complutense, Madrid, Spain

Official's Role

Study Director

Facility Information:

Facility Name

Department of Periodontology, University Complutense Madrid, Spain

City

Madrid

ZIP/Postal Code

28040

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24600654

Citation

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.

Results Reference

result

PubMed Identifier

16253095

Citation

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.

Results Reference

result

PubMed Identifier

28976050

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.

Results Reference

result

PubMed Identifier

29915931

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.

Results Reference

result

PubMed Identifier

30395825

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.

Results Reference

result

PubMed Identifier

30690733

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.

Results Reference

result

PubMed Identifier

20590963

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.

Results Reference

result

PubMed Identifier

31461778

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.

Results Reference

result

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

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