Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture
NCT ID: NCT04513886
Last Updated: 2020-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2018-11-19
2019-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Suture Group
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.
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.
no Suture Group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Maimonides University
OTHER
Mariel Viviana Gómez
OTHER
Responsible Party
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Mariel Viviana Gómez
Associate Professor. Department of Postgraduate Periodontics.
Principal Investigators
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Mariel V Gómez, Assoc Prof
Role: STUDY_DIRECTOR
Maimonides University
Guillermo Schinini, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
Maimonides University
Hugo J Romanelli, Chair Prof
Role: STUDY_CHAIR
Maimonides University
Diego Sales, Assist Prof
Role: PRINCIPAL_INVESTIGATOR
Maimonides University
Leandro Chambrone, Chair Prof
Role: PRINCIPAL_INVESTIGATOR
Ibirapuera University
Locations
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Maimonides University
Buenos Aires, Buenos Aires F.D., Argentina
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2310/18
Identifier Type: -
Identifier Source: org_study_id
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