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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03895476
• Other study ID #: IRB-300002777
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 8, 2020
• Est. completion date: August 2023

Study information

• Verified date: August 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: August 2023
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Palate; Wound

Intervention

Diagnostic Test:
• palatal wound will not cover
after harvesting the graft from the palate the wound will be left uncovered with secondary healing intention
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Unversity of Alabama at Birmingham, School of Dentistry	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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