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

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: Active, not recruiting
• Conditions: Gingival Recession; Palate; Wound
• Intervention / Treatment: Diagnostic test: palatal wound will not cover; Diagnostic test: palatal wound covered with platelet rich fibrin; Diagnostic test: palatal wound covered with a collagen sponge and cyanoacrylate; Diagnostic test: palatal wound covered with a stent

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; palatal wound will not be protected with any material	Diagnostic test: palatal wound will not cover; after harvesting the graft from the palate the wound will be left uncovered with secondary healing intention
Active Comparator: group 1; 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: group 2; 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: group 3; wound will consist of collagen protection with the application	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	To assessed the pain outcomes using the visual analog scale (VAS) from 0=No pain to 10=worst, excrutiating pain	day 1 to day 14
Bleeding assessment	To assessed the bleeding outcomes using the visual analog scale (VAS) from 0=No bruising/bleeding to 10=severe bruising/bleeding	day 1 to day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity Tolerance	To assessed the effects on daily activities using the VAS scale from 0=No Limitation to 10= Bedrest required	day 1 to days 14

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): July 30, 2021
• Study Completion (Anticipated): August 1, 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 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: IRB-300002777

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No