Wound Healing
Conditions
Keywords
wound healing, palate, connective tissue harvesting, single incision
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.
Interventions
PROCEDURESubepithelial 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.
Sponsors
Maimonides University
Mariel Viviana Gómez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early healing index | Day 7 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pain level / discomfort | first 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. |
Countries
Argentina
Outcome results
None listed