Trial Outcomes & Findings for To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting (NCT NCT03895476)
NCT ID: NCT03895476
Last Updated: 2024-08-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
day 14
Results posted on
2024-08-23
Participant Flow
Participant milestones
| Measure |
Collagen Plug With Sutures
Palatal wound will be protected with collagen plug and sutures.
palatal wound will be cover with collagen and sutures: after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
|
Platelet Rich Fibrin (PRF)
palatal wound will be protected with Platelet rich Fibrin
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
|
Collagen Plug With Cyanoacrylate (CPC)
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
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 Stent
Palatal wound will be protected with palatal stent.
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
Baseline characteristics by cohort
| Measure |
Collagen Plug With Sutures
n=18 Participants
Palatal wound will be protected with collagen plug and sutures.
palatal wound will be cover with collagen and sutures: after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
|
Platelet Rich Fibrin (PRF)
n=18 Participants
palatal wound will be protected with Platelet rich Fibrin
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
|
Collagen Plug With Cyanoacrylate (CPC)
n=18 Participants
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
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 Stent
n=18 Participants
Palatal wound will be protected with palatal stent.
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
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
65 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: day 14To 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.
Outcome measures
| Measure |
Collagen Plug With Sutures
n=18 Participants
Palatal wound will be protected with collagen plug and sutures.
palatal wound will be cover with collagen and sutures: after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
|
Platelet Rich Fibrin (PRF)
n=18 Participants
palatal wound will be protected with Platelet rich Fibrin
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
|
Collagen Plug With Cyanoacrylate (CPC)
n=18 Participants
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
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 Stent
n=18 Participants
Palatal wound will be protected with palatal stent.
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
|
|---|---|---|---|---|
|
Pain Assessment (0=No Pain to 10=Worst)
|
4.2 score on a scale
Standard Deviation 2.4
|
1.9 score on a scale
Standard Deviation 2.1
|
2.2 score on a scale
Standard Deviation 2.5
|
1 score on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: day 14To 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.
Outcome measures
| Measure |
Collagen Plug With Sutures
n=18 Participants
Palatal wound will be protected with collagen plug and sutures.
palatal wound will be cover with collagen and sutures: after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
|
Platelet Rich Fibrin (PRF)
n=18 Participants
palatal wound will be protected with Platelet rich Fibrin
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
|
Collagen Plug With Cyanoacrylate (CPC)
n=18 Participants
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
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 Stent
n=18 Participants
Palatal wound will be protected with palatal stent.
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
|
|---|---|---|---|---|
|
Bleeding Assessment
|
1 score on a scale
Standard Deviation 1.9
|
0.6 score on a scale
Standard Deviation 1.4
|
0.9 score on a scale
Standard Deviation 1.9
|
0.7 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: day 14To 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.
Outcome measures
| Measure |
Collagen Plug With Sutures
n=18 Participants
Palatal wound will be protected with collagen plug and sutures.
palatal wound will be cover with collagen and sutures: after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
|
Platelet Rich Fibrin (PRF)
n=18 Participants
palatal wound will be protected with Platelet rich Fibrin
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
|
Collagen Plug With Cyanoacrylate (CPC)
n=18 Participants
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
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 Stent
n=18 Participants
Palatal wound will be protected with palatal stent.
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
|
|---|---|---|---|---|
|
Activity Tolerance
|
2.4 score on a scale
Standard Deviation 2.4
|
1.5 score on a scale
Standard Deviation 2.1
|
1.8 score on a scale
Standard Deviation 2.4
|
1.3 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: day 14To 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.
Outcome measures
| Measure |
Collagen Plug With Sutures
n=18 Participants
Palatal wound will be protected with collagen plug and sutures.
palatal wound will be cover with collagen and sutures: after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
|
Platelet Rich Fibrin (PRF)
n=18 Participants
palatal wound will be protected with Platelet rich Fibrin
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
|
Collagen Plug With Cyanoacrylate (CPC)
n=18 Participants
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
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 Stent
n=18 Participants
Palatal wound will be protected with palatal stent.
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
|
|---|---|---|---|---|
|
Amount of Swelling
|
2.2 score on a scale
Standard Deviation 2.4
|
1.3 score on a scale
Standard Deviation 1.9
|
1.4 score on a scale
Standard Deviation 2
|
1.3 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: day 14To 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.
Outcome measures
| Measure |
Collagen Plug With Sutures
n=18 Participants
Palatal wound will be protected with collagen plug and sutures.
palatal wound will be cover with collagen and sutures: after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site
|
Platelet Rich Fibrin (PRF)
n=18 Participants
palatal wound will be protected with Platelet rich Fibrin
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
|
Collagen Plug With Cyanoacrylate (CPC)
n=18 Participants
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
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 Stent
n=18 Participants
Palatal wound will be protected with palatal stent.
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
|
|---|---|---|---|---|
|
The Need for Painkiller
|
2.1 score on a scale
Standard Deviation 2.5
|
2 score on a scale
Standard Deviation 2.6
|
2.2 score on a scale
Standard Deviation 2.8
|
1.5 score on a scale
Standard Deviation 1.8
|
Adverse Events
Collagen Plug With Sutures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Platelet Rich Fibrin (PRF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Collagen Plug With Cyanoacrylate (CPC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Palatal Stent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hussein Basma, DDS, MS
University of Alabama at Birmingham
Phone: 2059344506
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place