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

August 20, 2024 updated by: Hussein Basma, University of Alabama at Birmingham

A Randomized Controlled Trial to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • Unversity of Alabama at Birmingham, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Collagen Plug with sutures
Palatal wound will be protected with collagen plug and sutures.
Diagnostic test: palatal wound will be cover with collagen and sutures
after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
Active Comparator: Platelet Rich Fibrin (PRF)
palatal wound will be protected with Platelet rich Fibrin
Diagnostic test: palatal wound covered with platelet rich fibrin
after harvesting the graft from the palate the platelet rich fibrin will be sutured to covered the harvested site
Active Comparator: Collagen Plug with Cyanoacrylate (CPC)
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
Diagnostic test: palatal wound covered with a collagen sponge and cyanoacrylate
after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position
Active Comparator: Palatal Stent
Palatal wound will be protected with palatal stent.
Diagnostic test: palatal wound covered with a stent
after harvesting the graft from the palate a stent that will be prepared for the patient, will be placed on to cover the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessment (0=No Pain to 10=Worst)
Time Frame: day 14
To assess the pain outcomes using the visual analog scale from 0=No pain to 10=worst, excrutiating pain. Assessed daily from days 1 to 14, Day 14 reported.
day 14
Bleeding Assessment
Time Frame: day 14
To assessed the bleeding outcomes using the visual analog scale (VAS) from 0=No bruising/bleeding to 10=severe bruising/bleeding. Assessed daily from days 1 to 14, Day 14 reported.
day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity Tolerance
Time Frame: day 14
To assess the effects on daily activities using the visual analog scale from 0=No Limitation to 10= Bedrest required. Assessed daily from days 1 to 14, Day 14 reported.
day 14
Amount of Swelling
Time Frame: day 14
To assessed the swelling outcomes using the visual scale (VAS) from 0=No swelling to 10=severe swelling. Assessed daily from days 1 to 14, Day 14 reported.
day 14
The Need for Painkiller
Time Frame: day 14
To assess the needs for the painkiller using the visual analog scale (VAS). (0 = No painkiller needed to 10 = Needed painkiller). Assessed daily from days 1 to 14, Day 14 reported.
day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2020

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

February 27, 2023

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 29, 2019

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300002777
  • UAB Periodontology (Other Identifier: University of Alabama at Birmingham)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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