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

Not Applicable

Completed

• Conditions: Wound Healing
• Interventions: Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate

• Registration Number: NCT04513886
• Lead Sponsor: Mariel Viviana Gómez

Brief 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.

Study Timeline

• Study Start: 2018-11-19
• Primary Completion: 2019-08-26
• Study Completion: 2019-08-26
• Status Verified: 2020-08
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Study First Posted: 2020-08-14
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture Group	Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate	After harvesting a subepithelial connective tissue graft using the single incision technique collagen haemostatic sponge placement and subsequent compression with gauze soaked in saline for 5 minutes, a cross- mattress suture and interrupted single sutures were performed using nylon 5-0 when appropriate.
no Suture Group	Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate	After harvesting a subepithelial connective tissue graft using the single incision technique, collagen haemostatic sponge placement and subsequent compression with gauze soaked in saline for 5 minutes no suture was performed.

Primary Outcome Measures

Name	Time	Method
Early healing index	Day 30 post surgery	1. Complete flap closure without fibrin line at the palate; 2. Complete flap closure with fibrin line at the palate; 3. Complete flap closure with small fibrin clot(s) at the palate; 4. Incomplete flap closure with partial necrosis of the palatal tissue; 5. Incomplete flap closure with complete necrosis of the palatal tissue.

Secondary Outcome Measures

Name	Time	Method
Pain level / discomfort	second week after surgery,	Pain level / discomfort experienced at the surgical site of the palate, was self-reported by the subject and registered with a Visual Analogue Scale (VAS). It was required to the subject to graduate their sensitivity using a scale of 10 cm marked in mm between 0 and 100, labelled numerically from 0 to 10. Zero corresponds to "no discomfort" and 10 "unbearable pain". All other possible adverse effects were also recorded.
Number of participants with immediate bleeding	immediately postsurgery	An embedded gauze with saline was pressed on the palate wound for 5 minutes in both groups. Positive iB was recorded if once the gauze was removed, bleeding persisted. Compression was repeated as many times as necessary until bleeding was arrested. If this maneuver was not enough, additional actions should be performed to stop bleeding and the patient would be excluded from the study.
Number of participants with delayed bleeding	7 days post surgery	Any type of bleeding from the palatal area reported during the postoperative period was recorded as positive

Trial Locations

Locations (1)

Maimonides University; 🇦🇷 Ciudad Autonoma de Buenos Aires, Caba, Argentina