NCT04513886

Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture

Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mariel Viviana Gómez · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study evaluated the outcomes in the early healing of palatal wounds after harvesting a subepithelial connective tissue graft (SCTG) using the single incision technique with placement of a collagen haemostatic sponge (CHS) without suturing the palate. The primary outcome of this study was to evaluate the early wound healing index (EHI).

Detailed description

The aim of this study was to compare the outcomes in the early wound healing after harvesting a subepithelial connective tissue graft (SCTG) using the single incision technique and collagen haemostatic sponge (CHS) placement, with and without suturing the palate. 36 subjects were randomized to receive (n=18, Suture group-SG) or not a suture (n=18, no Suture group-nSG). Outcomes variables were: Early healing index (EHI) at 7, 14 and 30 days, self-reported pain using a visual analogue scale (VAS) at 7 and 14 days, immediate (iB) and delayed bleeding (dB). Data obtained were compared by Fisher's exact test, T test for independent sample, Mann-Whitney test (U test) and Wilcoxon sign test as appropriate. The level of significance was set at p \< 0.05. Statistical analysis was performed with Infostat version 2015.

Conditions

• Wound Healing

Interventions

Type	Name	Description
PROCEDURE	Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate	A SCTG was harvested using the single incision technique described by Hürzeler \& Weng. The palatal incisions were standardized to extend between the area between mesial of the canine and mesial of the first molar.In the Suture Group sites a cross- mattress suture and interrupted single sutures were performed using nylon 5-0 when appropriate. In the no Suture Group sites, no suture was performed. In both groups, a CHS was placed after removing the graft to achieve the haemostasis of the palate and subsequent compressed with gauze soaked in saline for 5 minutes.

Timeline

• Start date: 2018-11-19
• Primary completion: 2019-08-26
• Completion: 2019-08-26
• First posted: 2020-08-14
• Last updated: 2020-08-14

Locations

1 site across 1 country: Argentina