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Purpose

A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Subjects between 18-65 years of age. 2. Subjects need FGG or de-epithelialized Connective tissue graft 3. Good oral hygiene (Plaque and bleeding indexes <20%). 4. Subjects can withstand alginate impression or wear a retainer. 5. No other surgery or need for analgesics at the same site.

Exclusion Criteria

  1. Subjects with any systemic disorders that might compromise wound healing (Uncontrolled diabetes mellitus, rheumatoid arthritis, osteoporosis, chemotherapy/radiotherapy and immunological disorders). 2. Smokers 3. Patients not maintaining oral hygiene (plaque score >20%) 4. Pregnant or breastfeeding females. 5. Inability to provide informed consent. 6. Grafts thickness more than 2mm will be excluded from the study.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GROUP 1
L-PRF membranes will be placed on the palatal donor site to help stabilizing the blood clot and release of growth factors that help in deceasing the discomfort wound healing.
  • Biological: L-PRF (Leucocyte- platelet rich fibrin)
    Leucocyte-Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly. Patient's own blood is centrifuged using (Intra-spin) FDA approved centrifuge on 45 degrees angle on 2700 rpm for 12 minutes.
Experimental
GROUP 2
H-PRF membranes will be placed on the palatal donor site to help stabilizing the blood clot and release of growth factors that help in deceasing the discomfort wound healing.
  • Biological: H-PRF (Horizontal -platelet rich fibrin)
    Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly.Horizontally centrifuged platelet rich fibrin using (Bio-prf) centrifuge on 700 g force for 8 minutes. On a horizontal centrifugation, the cells separate much more efficiently throughout the entire membrane. This leads to better layer separation and also favors cells that are evenly distributed throughout the PRF clot.
Experimental
GROUP 3
A surgical stent will be delivered to cover the surgical site and apply pressure on the wound site.
  • Device: Surgical stent
    An essix surgical stent will be obtained using a high vacuum suction and used to protect the denuded donor site after suturing the wound. (BiostarĀ® Scan/BiostarĀ®V) will be used to make the stent.
    Other names:
    • Essix retainer

Recruiting Locations

More Details

NCT ID
NCT04758702
Status
Completed
Sponsor
Abdo Y Ismail

Detailed Description

A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site by comparing the percentage of re-epithelization of the palatal donor site at 5, 10, 14 and 21 days using a standardized intraoral palatal photo. The secondary objective is to compare the post op discomfort between the three groups during the healing period daily for 2 weeks using the Visual Analogue Scale (VAS) and Analgesic consumption. All subjects from the University of Kentucky College of Dentistry clinics. Subjects that are coming increasing the width of keratinized tissue or for the treatment of gingival recession, and match the inclusion criteria will be told about the research and offered the opportunity to participate.

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.