The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.
- Conditions
- Lack of Keratinized Gingiva
- Interventions
- Device: Surgical stentBiological: H-PRF (Horizontal -platelet rich fibrin)Biological: L-PRF (Leucocyte- platelet rich fibrin)
- Registration Number
- NCT04758702
- Lead Sponsor
- Abdo Y Ismail
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- Subjects with any systemic disorders that might compromise wound healing (Uncontrolled diabetes mellitus, rheumatoid arthritis, osteoporosis, chemotherapy/radiotherapy and immunological disorders).
- Smokers
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GROUP 3 Surgical stent A surgical stent will be delivered to cover the surgical site and apply pressure on the wound site. GROUP 2 H-PRF (Horizontal -platelet rich fibrin) 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. GROUP 1 L-PRF (Leucocyte- platelet rich fibrin) 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.
- Primary Outcome Measures
Name Time Method The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing. 21 days The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
- Secondary Outcome Measures
Name Time Method The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing. 21 days The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.
Trial Locations
- Locations (1)
University of Kentucky
🇺🇸Lexington, Kentucky, United States