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

NCT04513886 | Completed

• 1 other identifier: 2310/18
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Wound Healing

Keywords

wound healing; palate; connective tissue harvesting; single incision

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Number of participants with immediate bleeding

  immediately postsurgery

• Number of participants with delayed bleeding

  7 days post surgery

• Pain level / discomfort

  first week after surgery,

• Pain level / discomfort

  second week after surgery,

Study Arms (2)

Suture Group

ACTIVE COMPARATOR

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

no Suture Group

EXPERIMENTAL

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

Interventions

Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate PROCEDURE

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.

Suture Group; no Suture Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mariel Viviana Gómez: lead
• Maimonides University: collaborator

Study Sites (1)

Maimonides University

Buenos Aires, Buenos Aires F.D., 1405, Argentina

Location

Related Publications (9)

• 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.

  PMID: 29908088 BACKGROUND

• 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.

  PMID: 30517975 BACKGROUND

• 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.

  PMID: 11203571 BACKGROUND

• 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.

  PMID: 24562700 BACKGROUND

• 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.

  PMID: 31104113 BACKGROUND

• 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.

  PMID: 10588501 BACKGROUND

• 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.

  PMID: 18315424 BACKGROUND

• 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.

  PMID: 12423299 BACKGROUND

• 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.

  PMID: 10635174 RESULT

Study Officials

• Mariel V Gómez, Assoc Prof

  Maimonides University

  STUDY DIRECTOR

• Guillermo Schinini, Assoc Prof

  Maimonides University

  PRINCIPAL INVESTIGATOR

• Hugo J Romanelli, Chair Prof

  Maimonides University

  STUDY CHAIR

• Diego Sales, Assist Prof

  Maimonides University

  PRINCIPAL INVESTIGATOR

• Leandro Chambrone, Chair Prof

  Ibirapuera University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor. Department of Postgraduate Periodontics.

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 14, 2020
• Study Start: November 19, 2018
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)