Clinical trial NCT04513886: Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture
Official title: Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Keywords: wound healing
palate
connective tissue harvesting
single incision
Lead sponsor: Maimonides University
Sponsor class: OTHER
Collaborators: name: Maimonides University
First posted: 2020-08-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Early healing index
timeFrame: Day 7 post surgery
measure: Early healing index
timeFrame: Day 14 post surgery
measure: Early healing index
timeFrame: Day 30 post surgery
Secondary outcomes:
measure: Number of participants with immediate bleeding
timeFrame: immediately postsurgery
measure: Number of participants with delayed bleeding
timeFrame: 7 days post surgery
measure: Pain level / discomfort
timeFrame: first week after surgery,
measure: Pain level / discomfort
timeFrame: second week after surgery,
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Maimonides University
state: Caba
Study officials:
affiliation: Maimonides University
name: Mariel V Gómez, Assoc Prof
role: STUDY_DIRECTOR
affiliation: Maimonides University
name: Guillermo Schinini, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Maimonides University
name: Hugo J Romanelli, Chair Prof
role: STUDY_CHAIR
affiliation: Maimonides University
name: Diego Sales, Assist Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ibirapuera University
name: Leandro Chambrone, Chair Prof
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Fickl S, Fischer KR, Jockel-Schneider Y, Stappert CF, Schlagenhauf U, Kebschull M. Early wound healing and patient morbidity after single-incision vs. trap-door graft harvesting from the palate--a clinical study. Clin Oral Investig. 2014 Dec;18(9):2213-9. doi: 10.1007/s00784-014-1204-7. Epub 2014 Feb 23.
citation: Lektemur Alpan A, Torumtay Cin G. PRF improves wound healing and postoperative discomfort after harvesting subepithelial connective tissue graft from palate: a randomized controlled trial. Clin Oral Investig. 2020 Jan;24(1):425-436. doi: 10.1007/s00784-019-02934-9. Epub 2019 May 18.
citation: Rossmann JA, Rees TD. A comparative evaluation of hemostatic agents in the management of soft tissue graft donor site bleeding. J Periodontol. 1999 Nov;70(11):1369-75. doi: 10.1902/jop.1999.70.11.1369.
citation: Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.
citation: Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x.
citation: Hurzeler MB, Weng D. A single-incision technique to harvest subepithelial connective tissue grafts from the palate. Int J Periodontics Restorative Dent. 1999 Jun;19(3):279-87.