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

Not Applicable

Completed

• Conditions: Palate; Wound; Gingival Recession
• Interventions: Diagnostic Test: palatal wound will be cover with collagen and sutures; 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

• Registration Number: NCT03895476
• Lead Sponsor: University of Alabama at Birmingham

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.

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 Timeline

• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-29
• Study Start: 2020-06-08
• Primary Completion: 2021-07-30
• Study Completion: 2023-02-27
• Results First Submitted: 2023-08-04
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Results First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen Plug with sutures	palatal wound will be cover with collagen and sutures	Palatal wound will be protected with collagen plug and sutures.
Platelet Rich Fibrin (PRF)	palatal wound covered with platelet rich fibrin	palatal wound will be protected with Platelet rich Fibrin
Collagen Plug with Cyanoacrylate (CPC)	palatal wound covered with a collagen sponge and cyanoacrylate	Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
Palatal Stent	palatal wound covered with a stent	Palatal wound will be protected with palatal stent.

Primary Outcome Measures

Name	Time	Method
Pain Assessment (0=No Pain to 10=Worst)	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.
Bleeding Assessment	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.

Secondary Outcome Measures

Name	Time	Method
The Need for Painkiller	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.
Activity Tolerance	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.
Amount of Swelling	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.

Trial Locations

Locations (1)

Unversity of Alabama at Birmingham, School of Dentistry; 🇺🇸 Birmingham, Alabama, United States