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Use of Tilapia Skin for Palate Repair and Protection After Graft Removal

Primary Purpose

Pain, Postoperative, Palate; Wound, Cicatrization

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Tilapia skin
Surgical Wound Dressing
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients need periodontal or peri-implant surgical procedures requiring palate gingival graft

Exclusion Criteria:

  • Patients with an infectious condition that compromises the procedures
  • Users of drugs that can act on periodontal tissues or the healing process
  • Pregnant
  • Smokers
  • Diabetes
  • Irradiated

Sites / Locations

  • Bauru School of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tilapia skin

Surgical Wound Dressing

Arm Description

Procedure/Surgery: Free gingival graft harvesting from hard palate. After gingival graft harvesting from hard palate, it will be placed a tilapia skin as an occlusive biological dressing for palatal wound healing. Device: Tilapia skin. A xenogeneic collagen dressing will be placed over palate wound and stabilized with sutures during the healing process.

Procedure/Surgery: Free gingival graft harvesting from hard palate. After gingival graft harvesting from hard palate, it will be placed a surgical wound dressing as a mechanical protection during palatal wound healing. Device: Surgical wound dressing A surgical wound dressing will be placed over palate wound during the healing process to provide mechanical protection.

Outcomes

Primary Outcome Measures

Self-reported pain perception evaluated by a visual analog scale
Patient's self-reported pain perception will be evaluated using a visual analog scale with a score ranging from 0 (no pain) to 10 (unbearable pain).

Secondary Outcome Measures

Self-reported discomfort evaluated by a visual analog scale
Patient's self-reported discomfort will be evaluated using a visual analog scale with a score ranging from 0 (no discomfort) to 2 (high discomfort).
Self-reported trouble with speech evaluated by a visual analog scale
Patient's self-reported trouble with speech will be evaluated using a visual analog scale with a score ranging from 0 (no trouble) to 2 (high trouble).
Self-reported trouble with eating evaluated by a visual analog scale
Patient's self-reported trouble with eating will be evaluated using a visual analog scale with a score ranging from 0 (no trouble) to 2 (high trouble).
Comparison of the palate healing process evaluated through linear measurements (millimiter)
Pictures will be taken immediately after the gingival graft harvesting and compared with post-operativa pictures through the use of linear measurements at Image J.
Number of analgesic pills taken after surgery
Evaluate the patient's perception of postoperative pain and discomfort by counting the number of analgesic pills taken after the surgery.

Full Information

First Posted
September 27, 2019
Last Updated
August 26, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04168125
Brief Title
Use of Tilapia Skin for Palate Repair and Protection After Graft Removal
Official Title
Use of Tilapia Skin for Palate Repair and Protection After Graft Removal
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
November 23, 2020 (Anticipated)
Study Completion Date
March 24, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomised Clinical Study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.
Detailed Description
Autogenous grafts are currently considered the gold standard in regenerative and reconstructive procedures. However, these procedures require a second surgical site to provide the tissue graft. In autogenous gingival grafts, the area commonly selected for graft harvesting is the palate, which is linked to great discomfort and morbidity for the patient. In order to overcome these limitations, xenogeneic and alloplastic materials have been tested as tissue substitutes, but their results are still considerably inferior when compared to autogenous grafts. Faced with this superiority, another approach to favor the use of autogenous grafting is to develop materials that provide greater postoperative comfort and patient safety. Since the main complaint arising from the technique is related to pain resulting from the remaining surgical wound on the palate, it is interesting to look for mechanisms to reduce this sensitivity and accelerate the healing process. For this, the use of tilapia skin as a postoperative dressing seems to be a good alternative. Thus, the purpose of this study is to evaluate the use of tilapia skin, with the intention of accelerating the palate healing process, and to serve as a protector barrier during the healing process. Patients treated according to two techniques for palate protection after autogenous gingival graft harvesting will be evaluated: C- use of surgical cement and T- use of tilapia skin. Will be selected 60 patients of both sexes,> 18 years old, requiring the removal of the palate graft for periodontal surgery. At the time of graft removal, palate thickness and graft dimensions will be measured. After 7, 14 and 30 days, the patient's discomfort and the difficulty in chewing and speaking will be recorded through a visual analog scale, the consumption of analgesic, and the dimensions of the surgical wound on the palate. For statistical analysis, two-way ANOVA will be performed and t-test paired on the obtained results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Palate; Wound, Cicatrization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tilapia skin
Arm Type
Experimental
Arm Description
Procedure/Surgery: Free gingival graft harvesting from hard palate. After gingival graft harvesting from hard palate, it will be placed a tilapia skin as an occlusive biological dressing for palatal wound healing. Device: Tilapia skin. A xenogeneic collagen dressing will be placed over palate wound and stabilized with sutures during the healing process.
Arm Title
Surgical Wound Dressing
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Free gingival graft harvesting from hard palate. After gingival graft harvesting from hard palate, it will be placed a surgical wound dressing as a mechanical protection during palatal wound healing. Device: Surgical wound dressing A surgical wound dressing will be placed over palate wound during the healing process to provide mechanical protection.
Intervention Type
Device
Intervention Name(s)
Tilapia skin
Intervention Description
Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
Intervention Type
Device
Intervention Name(s)
Surgical Wound Dressing
Intervention Description
Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
Primary Outcome Measure Information:
Title
Self-reported pain perception evaluated by a visual analog scale
Description
Patient's self-reported pain perception will be evaluated using a visual analog scale with a score ranging from 0 (no pain) to 10 (unbearable pain).
Time Frame
14 days after the surgery
Secondary Outcome Measure Information:
Title
Self-reported discomfort evaluated by a visual analog scale
Description
Patient's self-reported discomfort will be evaluated using a visual analog scale with a score ranging from 0 (no discomfort) to 2 (high discomfort).
Time Frame
14 days after the surgery
Title
Self-reported trouble with speech evaluated by a visual analog scale
Description
Patient's self-reported trouble with speech will be evaluated using a visual analog scale with a score ranging from 0 (no trouble) to 2 (high trouble).
Time Frame
14 days after the surgery
Title
Self-reported trouble with eating evaluated by a visual analog scale
Description
Patient's self-reported trouble with eating will be evaluated using a visual analog scale with a score ranging from 0 (no trouble) to 2 (high trouble).
Time Frame
14 days after the surgery
Title
Comparison of the palate healing process evaluated through linear measurements (millimiter)
Description
Pictures will be taken immediately after the gingival graft harvesting and compared with post-operativa pictures through the use of linear measurements at Image J.
Time Frame
30 days after the surgery
Title
Number of analgesic pills taken after surgery
Description
Evaluate the patient's perception of postoperative pain and discomfort by counting the number of analgesic pills taken after the surgery.
Time Frame
14 days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients need periodontal or peri-implant surgical procedures requiring palate gingival graft Exclusion Criteria: Patients with an infectious condition that compromises the procedures Users of drugs that can act on periodontal tissues or the healing process Pregnant Smokers Diabetes Irradiated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo GP Manfredi, MSc
Phone
+5518981711825
Email
gustavo.manfredi@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana CP Sant'Ana, PhD
Organizational Affiliation
Bauru School of Dentistry - University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Bauru School of Dentistry
City
Bauru
ZIP/Postal Code
17012-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Gonçalves do P Manfredi, MSc
Phone
18981711825

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Tilapia Skin for Palate Repair and Protection After Graft Removal

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