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

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ClinicalTrials.gov Identifier: NCT04513886
Recruitment Status : Completed
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
Maimonides University
Information provided by (Responsible Party):
Mariel Viviana Gómez, Maimonides University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Wound Healing Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture: A Randomized Controlled Trial
Actual Study Start Date : November 19, 2018
Actual Primary Completion Date : August 26, 2019
Actual Study Completion Date : August 26, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 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.
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Early healing index [ Time Frame: 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.

  2. Early healing index [ Time Frame: Day 14 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.

  3. Early healing index [ Time Frame: Day 30 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 Outcome Measures :
  1. Number of participants with immediate bleeding [ Time Frame: 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.

  2. Number of participants with delayed bleeding [ Time Frame: 7 days post surgery ]
    Any type of bleeding from the palatal area reported during the postoperative period was recorded as positive

  3. Pain level / discomfort [ Time Frame: 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.

  4. Pain level / discomfort [ Time Frame: second 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513886


Locations
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Argentina
Maimonides University
Ciudad Autonoma de Buenos Aires, Caba, Argentina, 1405
Sponsors and Collaborators
Mariel Viviana Gómez
Maimonides University
Investigators
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Study Director: Mariel V Gómez, Assoc Prof Maimonides University
Principal Investigator: Guillermo Schinini, Assoc Prof Maimonides University
Study Chair: Hugo J Romanelli, Chair Prof Maimonides University
Principal Investigator: Diego Sales, Assist Prof Maimonides University
Principal Investigator: Leandro Chambrone, Chair Prof Ibirapuera University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Mariel Viviana Gómez, Associate Professor. Department of Postgraduate Periodontics., Maimonides University
ClinicalTrials.gov Identifier: NCT04513886    
Other Study ID Numbers: 2310/18
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mariel Viviana Gómez, Maimonides University:
wound healing
palate
connective tissue harvesting
single incision