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

Mariel Viviana Gómez

Status: Completed

Conditions: Wound Healing

Treatments: Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate

Study type: Interventional

Funder types: Other

Identifiers

NCT04513886

2310/18

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Subjects with an indication of mucogingival surgery for single gingival recession treatment that required harvesting a subepithelial connective tissue graft
• Age >18 years ≤ 60 years.
• Periodontally and systemically healthy.
• Palatal fibromucosa width ≥ 2mm evaluated with a North Carolina probe placed perpendicular to the hard palate, prior to surgery.

Exclusion Criteria

• Smoking.
• Contraindications for periodontal surgery.
• Subjects presenting coagulation disorders (history of Haemophilia, von Willebrand disease or anticoagulant therapy).
• Subjects taking medications known to interfere with periodontal tissue health or healing.
• Subjects that had been operated on the palate (connective tissue removed) previously from that same donor area.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Suture Group

Active Comparator group

Description:

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.

Treatment:

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

no Suture Group

Experimental group

Description:

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.

Treatment:

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