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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
control group 		palatal wound will not be protected with any material
  • Diagnostic Test: palatal wound will not cover
    after harvesting the graft from the palate the wound will be left uncovered with secondary healing intention
Active Comparator
group 1 		palatal wound will be protected with Platelet rich Fibrin
  • Diagnostic Test: 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
Active Comparator
group 2 		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
    after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position
Active Comparator
group 3 		wound will consist of collagen protection with the application
  • Diagnostic Test: 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

More Details

Status
Active, not recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.