NCT03895476

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

Completed NA Results posted Last updated 23 August 2024

What this trial tests

NA trial testing palatal wound will be cover with collagen and sutures in Gingival Recession in 72 participants. Completed in 27 February 2023.

Timeline

8 June 2020

Primary endpoint
30 July 2021

27 February 2023

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	72
Start date	8 June 2020
Primary completion	30 July 2021
Estimated completion	27 February 2023
Sites	1 location across United States

Drugs / interventions tested

• palatal wound will be cover with collagen and sutures
• palatal wound covered with platelet rich fibrin
• palatal wound covered with a collagen sponge and cyanoacrylate
• palatal wound covered with a stent

Conditions studied

• Gingival Recession — all drugs for Gingival Recession →
• Palate; Wound — all drugs for Palate; Wound →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 70, any sex, with Gingival Recession or Palate; Wound. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Assessment (0=No Pain to 10=Worst) Primary · 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.

Group	Value	95% CI
Collagen Plug With Sutures	4.2	± 2.4
Platelet Rich Fibrin (PRF)	1.9	± 2.1
Collagen Plug With Cyanoacrylate (CPC)	2.2	± 2.5
Palatal Stent	1	± 1.4

Bleeding Assessment Primary · 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.

Group	Value	95% CI
Collagen Plug With Sutures	1	± 1.9
Platelet Rich Fibrin (PRF)	0.6	± 1.4
Collagen Plug With Cyanoacrylate (CPC)	0.9	± 1.9
Palatal Stent	0.7	± 1.6

Activity Tolerance Secondary · 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.

Group	Value	95% CI
Collagen Plug With Sutures	2.4	± 2.4
Platelet Rich Fibrin (PRF)	1.5	± 2.1
Collagen Plug With Cyanoacrylate (CPC)	1.8	± 2.4
Palatal Stent	1.3	± 1.8

Amount of Swelling Secondary · 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.

Group	Value	95% CI
Collagen Plug With Sutures	2.2	± 2.4
Platelet Rich Fibrin (PRF)	1.3	± 1.9
Collagen Plug With Cyanoacrylate (CPC)	1.4	± 2
Palatal Stent	1.3	± 2

The Need for Painkiller Secondary · 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.

Group	Value	95% CI
Collagen Plug With Sutures	2.1	± 2.5
Platelet Rich Fibrin (PRF)	2	± 2.6
Collagen Plug With Cyanoacrylate (CPC)	2.2	± 2.8
Palatal Stent	1.5	± 1.8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.