A Randomized Controlled Trial to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gingival Recession
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Pain Assessment (0=No Pain to 10=Worst)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Hussein Basma
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pain Assessment (0=No Pain to 10=Worst)
Time Frame: 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
Time Frame: 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 Outcomes
- The Need for Painkiller(day 14)
- Activity Tolerance(day 14)
- Amount of Swelling(day 14)