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

The University of Alabama at Birmingham

Status: Completed

Conditions: Palate; Wound; Gingival Recession

Treatments: Diagnostic Test: palatal wound covered with a stent; Diagnostic Test: palatal wound covered with a collagen sponge and cyanoacrylate; Diagnostic Test: palatal wound covered with platelet rich fibrin; Diagnostic Test: palatal wound will be cover with collagen and sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT03895476

IRB-300002777

UAB Periodontology (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

Collagen Plug with sutures

Active Comparator group

Description:

Palatal wound will be protected with collagen plug and sutures.

Treatment:

Diagnostic Test: palatal wound will be cover with collagen and sutures

Platelet Rich Fibrin (PRF)

Active Comparator group

Description:

palatal wound will be protected with Platelet rich Fibrin

Treatment:

Diagnostic Test: palatal wound covered with platelet rich fibrin

Collagen Plug with Cyanoacrylate (CPC)

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: palatal wound covered with a collagen sponge and cyanoacrylate

Palatal Stent

Active Comparator group

Description:

Palatal wound will be protected with palatal stent.

Treatment:

Diagnostic Test: palatal wound covered with a stent