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To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting

Primary Purpose

Gingival Recession, Palate; Wound

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
palatal wound will not cover
palatal wound covered with platelet rich fibrin
palatal wound covered with a collagen sponge and cyanoacrylate
palatal wound covered with a stent
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Recession

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English speaking
  • At least 18 years old- 70 years old
  • Must be a patient of the UAB Dental School
  • Able to read and understand informed consent document
  • Patients needing soft tissue graft with teeth that have miller class I or II recession (>=2mm) on the facial aspects
  • Presence of periodontally healthy teeth at the recipient site.
  • Ability of the participants to maintain good oral hygiene
  • Patient not pregnant or breastfeeding
  • Not taking medications known to cause gingival enlargement

Exclusion Criteria:

  • Non-English speaking
  • Less than 18 years old, older than 70 years old
  • Smokers/tobacco users
  • Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
  • Patients that have severe gingival recession (Miller class III and IV) or < 2 mm.
  • Presence of periodontal disease at the recipient site.
  • Poor oral hygiene
  • Patient pregnant or breastfeeding
  • Taking medications known to cause gingival enlargement

Sites / Locations

  • Unversity of Alabama at Birmingham, School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

control group

group 1

group 2

group 3

Arm Description

palatal wound will not be protected with any material

palatal wound will be protected with Platelet rich Fibrin

wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.

wound will consist of collagen protection with the application

Outcomes

Primary Outcome Measures

Pain assessment
To assessed the pain outcomes using the visual analog scale (VAS) from 0=No pain to 10=worst, excrutiating pain
Bleeding assessment
To assessed the bleeding outcomes using the visual analog scale (VAS) from 0=No bruising/bleeding to 10=severe bruising/bleeding

Secondary Outcome Measures

Activity Tolerance
To assessed the effects on daily activities using the VAS scale from 0=No Limitation to 10= Bedrest required

Full Information

First Posted
March 26, 2019
Last Updated
August 24, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03895476
Brief Title
To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
Official Title
A Randomized Controlled Trial to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

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
This randomized clinical comparative study will evaluate the postoperative pain following the FGG graft harvest procedure technique covered by four different methods for coverage of the palatal donor site.
Detailed Description
This study will compare the application of : hemostatic collagen sponge collagen sponge sealed with abio-adhesive material Platelet rich fibrin physical barrier (stent) on the palatal donor sites with the purpose of which one of these will result in least postoperative pain after epithelialized gingival graft (EGG) harvesting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Palate; Wound

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
palatal wound will not be protected with any material
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
palatal wound will be protected with Platelet rich Fibrin
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
Arm Title
group 3
Arm Type
Active Comparator
Arm Description
wound will consist of collagen protection with the application
Intervention Type
Diagnostic Test
Intervention Name(s)
palatal wound will not cover
Intervention Description
after harvesting the graft from the palate the wound will be left uncovered with secondary healing intention
Intervention Type
Diagnostic Test
Intervention Name(s)
palatal wound covered with platelet rich fibrin
Intervention Description
after harvesting the graft from the palate the platelet rich fibrin will be sutured to covered the harvested site
Intervention Type
Diagnostic Test
Intervention Name(s)
palatal wound covered with a collagen sponge and cyanoacrylate
Intervention Description
after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position
Intervention Type
Diagnostic Test
Intervention Name(s)
palatal wound covered with a stent
Intervention Description
after harvesting the graft from the palate a stent that will be prepared for the patient, will be placed on to cover the wound
Primary Outcome Measure Information:
Title
Pain assessment
Description
To assessed the pain outcomes using the visual analog scale (VAS) from 0=No pain to 10=worst, excrutiating pain
Time Frame
day 1 to day 14
Title
Bleeding assessment
Description
To assessed the bleeding outcomes using the visual analog scale (VAS) from 0=No bruising/bleeding to 10=severe bruising/bleeding
Time Frame
day 1 to day 14
Secondary Outcome Measure Information:
Title
Activity Tolerance
Description
To assessed the effects on daily activities using the VAS scale from 0=No Limitation to 10= Bedrest required
Time Frame
day 1 to days 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking At least 18 years old- 70 years old Must be a patient of the UAB Dental School Able to read and understand informed consent document Patients needing soft tissue graft with teeth that have miller class I or II recession (>=2mm) on the facial aspects Presence of periodontally healthy teeth at the recipient site. Ability of the participants to maintain good oral hygiene Patient not pregnant or breastfeeding Not taking medications known to cause gingival enlargement Exclusion Criteria: Non-English speaking Less than 18 years old, older than 70 years old Smokers/tobacco users Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing Patients that have severe gingival recession (Miller class III and IV) or < 2 mm. Presence of periodontal disease at the recipient site. Poor oral hygiene Patient pregnant or breastfeeding Taking medications known to cause gingival enlargement
Facility Information:
Facility Name
Unversity of Alabama at Birmingham, School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States

12. IPD Sharing Statement

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To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting

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