An interventional study of Simplified suture-less approach and Application of hemostatic sponges and compressive sutures in Thin-gingiva, Mucogingival Deformity on Edentulous Ridge and Gingival Recession, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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).
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 34 is above the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Systemic primary exclusion criteria:
Local primary exclusion criteria:
Secondary exclusion criteria:
a. Non compliant patients: poor oral hygiene (FMPS >20%) at 2 consecutive visits.
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
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, 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.
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.
Palatal microvascular healing
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
Postoperative bleeding
Occurrence of postoperative bleeding during the first two postoperative weeks reported by the patients through a dedicated questionnaire
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 7 days after surgery, 14 days after surgery, 30 days after surgery
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Complutense de Madrid