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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wound Healing

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were assigned to one of two groups in parallel for the duration of the study: This study was a non-masked, randomized, controlled clinical trial, with a parallel design, comparing early healing of palatal wounds after harvesting subepithelial connective tissue graft using the single incision technique, with and without palatal sutures.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture Group<br>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. | Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate<br>* 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.<br>|
| Experimental: no Suture Group<br>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. | Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early healing index | 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. | Day 7 post surgery | 
| Early healing index | 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. | Day 14 post surgery | 
| Early healing index | 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. | Day 30 post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with immediate bleeding | 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. | immediately postsurgery | 
| Number of participants with delayed bleeding | Any type of bleeding from the palatal area reported during the postoperative period was recorded as positive | 7 days post surgery | 
| Pain level / discomfort | 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. | first week after surgery, | 
| Pain level / discomfort | 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. | second week after surgery, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, palate, connective tissue harvesting, single incision