Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UAB Periodontology | Other Identifier | University of Alabama at Birmingham |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen Plug with sutures | Active Comparator | Palatal wound will be protected with collagen plug and sutures. |
|
| Platelet Rich Fibrin (PRF) | Active Comparator | palatal wound will be protected with Platelet rich Fibrin |
|
| Collagen Plug with Cyanoacrylate (CPC) | Active Comparator | Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue. |
|
| Palatal Stent | Active Comparator | Palatal wound will be protected with palatal stent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palatal wound will be cover with collagen and sutures | Diagnostic Test | after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 14 |
| Amount of Swelling |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Alabama at Birmingham, School of Dentistry | Birmingham | Alabama | 35294-0007 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Platelet Rich Fibrin (PRF) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| palatal wound covered with platelet rich fibrin | Diagnostic Test | after harvesting the graft from the palate the platelet rich fibrin will be sutured to covered the harvested site |
|
| palatal wound covered with a collagen sponge and cyanoacrylate | Diagnostic Test | after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position |
|
| palatal wound covered with a stent | Diagnostic Test | after harvesting the graft from the palate a stent that will be prepared for the patient, will be placed on to cover the wound |
|
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.
| 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. | day 14 |
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 |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | day 14 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | day 14 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | day 14 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | day 14 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | day 14 |
|
14 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hussein Basma, DDS, MS | University of Alabama at Birmingham | 2059344506 | basma86@uab.edu |
| Jul 19, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|