The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing: A Randomized, Three Parallel Arms Clinical Trial.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects between 18-65 years of age.
- •Subjects need FGG or de-epithelialized Connective tissue graft
- •Good oral hygiene (Plaque and bleeding indexes <20%).
- •Subjects can withstand alginate impression or wear a retainer.
- •No other surgery or need for analgesics at the same site.
Exclusion Criteria
- •Subjects with any systemic disorders that might compromise wound healing (Uncontrolled diabetes mellitus, rheumatoid arthritis, osteoporosis, chemotherapy/radiotherapy and immunological disorders).
- •Patients not maintaining oral hygiene (plaque score >20%)
- •Pregnant or breastfeeding females.
- •Inability to provide informed consent.
- •Grafts thickness more than 2mm will be excluded from the study.
Outcomes
Primary Outcomes
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time Frame: 21 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
Secondary Outcomes
- The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.(21 days)
Investigators
Abdo Y Ismail
Post-graduate Periodontics Resident
University of Kentucky