CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Simplified suture-less approach +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05381623
NCT05381623N/ACompleted

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

Universidad Complutense de Madrid·interventional·Posted May 19, 2022·Updated Oct 4, 2023

In Brief

A clinical study evaluating Simplified suture-less approach and Application of hemostatic sponges and compressive sutures for Thin-gingiva and 2 related conditions. Completed, enrolled 34 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 19, 2022
Enrollment StartMay 20, 2022
Primary CompletionJun 14, 2022
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 24 daysPosted 4.1 years ago

Interventions

Simplified suture-less approachprocedure

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.

Application of hemostatic sponges and compressive suturesprocedure

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.