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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting

Conditions
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Gingival Recession, Palate; Wound

Intervention / Treatment
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* Diagnostic Test: palatal wound will not cover
* Diagnostic Test: palatal wound covered with platelet rich fibrin
* Diagnostic Test: palatal wound covered with a collagen sponge and cyanoacrylate
* Diagnostic Test: palatal wound covered with a stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>palatal wound will not be protected with any material | Diagnostic Test: palatal wound will not cover<br>* after harvesting the graft from the palate the wound will be left uncovered with secondary healing intention<br>|
| Active Comparator: group 1<br>palatal wound will be protected with Platelet rich Fibrin | Diagnostic Test: palatal wound covered with platelet rich fibrin<br>* after harvesting the graft from the palate the platelet rich fibrin will be sutured to covered the harvested site<br>|
| Active Comparator: group 2<br>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<br>* after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position<br>|
| Active Comparator: group 3<br>wound will consist of collagen protection with the application | Diagnostic Test: palatal wound covered with a stent<br>* after harvesting the graft from the palate a stent that will be prepared for the patient, will be placed on to cover the wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | To assessed the pain outcomes using the visual analog scale (VAS) from 0=No pain to 10=worst, excrutiating pain | day 1 to 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 | day 1 to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Tolerance | To assessed the effects on daily activities using the VAS scale from 0=No Limitation to 10= Bedrest required | day 1 to days 14 |