An interventional study of palatal wound will be cover with collagen and sutures and palatal wound covered with platelet rich fibrin in Gingival Recession and Palate; Wound, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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.
This study will compare the application of :
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 72 is above the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Palatal wound will be protected with collagen plug and sutures.
Diagnostic Test: palatal wound will be cover with collagen and sutures
palatal wound will be protected with Platelet rich Fibrin
Diagnostic Test: palatal wound covered with platelet rich fibrin
Palatal 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
Palatal wound will be protected with palatal stent.
Diagnostic Test: palatal wound covered with a stent
after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
after harvesting the graft from the palate the platelet rich fibrin will be sutured to covered the harvested site
after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position
after harvesting the graft from the palate a stent that will be prepared for the patient, will be placed on to cover the wound
Pain Assessment (0=No Pain to 10=Worst)
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.
Time frame: day 14
Bleeding Assessment
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.
Time frame: day 14
Activity Tolerance
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.
Time frame: day 14
Amount of Swelling
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.
Time frame: day 14
The Need for Painkiller
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.
Time frame: day 14
| Milestone | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent |
|---|---|---|---|---|
| Started | 18 | 18 | 18 | 18 |
| Completed | 18 | 18 | 18 | 18 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| score on a scale | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent |
|---|---|---|---|---|
| Pain Assessment (0=No Pain to 10=Worst) | 4.2 ± 2.4 | 1.9 ± 2.1 | 2.2 ± 2.5 | 1 ± 1.4 |
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.
| score on a scale | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent |
|---|---|---|---|---|
| Bleeding Assessment | 1 ± 1.9 | 0.6 ± 1.4 | 0.9 ± 1.9 | 0.7 ± 1.6 |
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.
| score on a scale | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent |
|---|---|---|---|---|
| Activity Tolerance | 2.4 ± 2.4 | 1.5 ± 2.1 | 1.8 ± 2.4 | 1.3 ± 1.8 |
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.
| score on a scale | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent |
|---|---|---|---|---|
| Amount of Swelling | 2.2 ± 2.4 | 1.3 ± 1.9 | 1.4 ± 2 | 1.3 ± 2 |
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.
| score on a scale | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent |
|---|---|---|---|---|
| The Need for Painkiller | 2.1 ± 2.5 | 2 ± 2.6 | 2.2 ± 2.8 | 1.5 ± 1.8 |
Collected over 14 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Collagen Plug With Sutures | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Platelet Rich Fibrin (PRF) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Collagen Plug With Cyanoacrylate (CPC) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Palatal Stent | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent | Total |
|---|---|---|---|---|---|
| <=18 years | 1 | 0 | 0 | 0 | 1 |
| Between 18 and 65 years | 10 | 6 | 15 | 12 | 43 |
| >=65 years | 7 | 12 | 3 | 6 | 28 |
| Sex: Female, Male(Participants) | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent | Total |
|---|---|---|---|---|---|
| Female | 11 | 14 | 10 | 10 | 45 |
| Male | 7 | 4 | 8 | 8 | 27 |
| Race (NIH/OMB)(Participants) | Collagen Plug With Sutures | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Palatal Stent | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 | 1 | 5 |
| White | 17 | 17 | 16 | 15 | 65 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
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University of Alabama at Birmingham