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

Wound Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513886
• Other study ID #: 2310/18
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: August 26, 2019

Study information

• Verified date: August 2020
• Source: Maimonides University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 26, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Healing

Intervention

Procedure:
• Subepithelial 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.

Locations

Country	Name	City	State
Argentina	Maimonides University	Ciudad Autonoma de Buenos Aires	Caba

Sponsors (2)

Lead Sponsor	Collaborator
Mariel Viviana Gómez	Maimonides University

Country where clinical trial is conducted

Argentina, 

References & Publications (9)

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. — View 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. — View Citation

Hürzeler 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. — View 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. — View Citation

Lorenzana ER, Allen EP. The single-incision palatal harvest technique: a strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 2000 Jun;20(3):297-305. — View Citation

Maino GNE, Valles C, Santos A, Pascual A, Esquinas C, Nart J. Influence of suturing technique on wound healing and patient morbidity after connective tissue harvesting. A randomized clinical trial. J Clin Periodontol. 2018 Aug;45(8):977-985. doi: 10.1111/jcpe.12960. Epub 2018 Jul 24. — View 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. — View Citation

Stavropoulou C, Atout RN, Brownlee M, Schroth RJ, Kelekis-Cholakis A. A randomized clinical trial of cyanoacrylate tissue adhesives in donor site of connective tissue grafts. J Periodontol. 2019 Jun;90(6):608-615. doi: 10.1002/JPER.18-0475. Epub 2018 Dec 26. — View 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 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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,
Secondary	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,