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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03895476

Collaborator

(none)

Enrollment

Location

Arms

37.7

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession Palate; Wound	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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 8, 2020

Actual Primary Completion Date :

Jul 30, 2021

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Pain assessment [day 1 to day 14]
To assessed the pain outcomes using the visual analog scale (VAS) from 0=No pain to 10=worst, excrutiating pain
Bleeding assessment [day 1 to day 14]
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 [day 1 to days 14]
To assessed the effects on daily activities using the VAS scale from 0=No Limitation to 10= Bedrest required

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unversity of Alabama at Birmingham, School of Dentistry	Birmingham	Alabama	United States	35294-0007

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hussein Basma, Principal Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03895476

Other Study ID Numbers:

IRB-300002777

First Posted:

Mar 29, 2019

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingival Recession

Study Results

No Results Posted as of Aug 25, 2022