Gingival Recession, Palate; Wound
Conditions
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.
Interventions
DIAGNOSTIC_TESTpalatal 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
DIAGNOSTIC_TESTpalatal 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
DIAGNOSTIC_TESTpalatal 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
DIAGNOSTIC_TESTpalatal 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
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 18 |
| 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 | 18 |
| 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 | 18 |
| Total | 72 |
Baseline characteristics
| Characteristic | Platelet Rich Fibrin (PRF) | Collagen Plug With Cyanoacrylate (CPC) | Collagen Plug With Sutures | Palatal Stent | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 12 Participants | 3 Participants | 7 Participants | 6 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 15 Participants | 10 Participants | 12 Participants | 43 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 16 Participants | 17 Participants | 15 Participants | 65 Participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 11 Participants | 10 Participants | 45 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 7 Participants | 8 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
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.
Time frame: day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collagen Plug With Sutures | Bleeding Assessment | 1 score on a scale | Standard Deviation 1.9 |
| Platelet Rich Fibrin (PRF) | Bleeding Assessment | 0.6 score on a scale | Standard Deviation 1.4 |
| Collagen Plug With Cyanoacrylate (CPC) | Bleeding Assessment | 0.9 score on a scale | Standard Deviation 1.9 |
| Palatal Stent | Bleeding Assessment | 0.7 score on a scale | Standard Deviation 1.6 |
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.
Time frame: day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collagen Plug With Sutures | Pain Assessment (0=No Pain to 10=Worst) | 4.2 score on a scale | Standard Deviation 2.4 |
| Platelet Rich Fibrin (PRF) | Pain Assessment (0=No Pain to 10=Worst) | 1.9 score on a scale | Standard Deviation 2.1 |
| Collagen Plug With Cyanoacrylate (CPC) | Pain Assessment (0=No Pain to 10=Worst) | 2.2 score on a scale | Standard Deviation 2.5 |
| Palatal Stent | Pain Assessment (0=No Pain to 10=Worst) | 1 score on a scale | Standard Deviation 1.4 |
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.
Time frame: day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collagen Plug With Sutures | Activity Tolerance | 2.4 score on a scale | Standard Deviation 2.4 |
| Platelet Rich Fibrin (PRF) | Activity Tolerance | 1.5 score on a scale | Standard Deviation 2.1 |
| Collagen Plug With Cyanoacrylate (CPC) | Activity Tolerance | 1.8 score on a scale | Standard Deviation 2.4 |
| Palatal Stent | Activity Tolerance | 1.3 score on a scale | Standard Deviation 1.8 |
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.
Time frame: day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collagen Plug With Sutures | Amount of Swelling | 2.2 score on a scale | Standard Deviation 2.4 |
| Platelet Rich Fibrin (PRF) | Amount of Swelling | 1.3 score on a scale | Standard Deviation 1.9 |
| Collagen Plug With Cyanoacrylate (CPC) | Amount of Swelling | 1.4 score on a scale | Standard Deviation 2 |
| Palatal Stent | Amount of Swelling | 1.3 score on a scale | Standard Deviation 2 |
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.
Time frame: day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collagen Plug With Sutures | The Need for Painkiller | 2.1 score on a scale | Standard Deviation 2.5 |
| Platelet Rich Fibrin (PRF) | The Need for Painkiller | 2 score on a scale | Standard Deviation 2.6 |
| Collagen Plug With Cyanoacrylate (CPC) | The Need for Painkiller | 2.2 score on a scale | Standard Deviation 2.8 |
| Palatal Stent | The Need for Painkiller | 1.5 score on a scale | Standard Deviation 1.8 |