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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: L-PRF (Leucocyte- platelet rich fibrin) (Biological)
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.
干预措施: H-PRF (Horizontal -platelet rich fibrin) (Biological)
GROUP 3
A surgical stent will be delivered to cover the surgical site and apply pressure on the wound site.
干预措施: Surgical stent (Device)
结局指标
主要结局
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
时间窗: 21 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
时间窗: 5 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
时间窗: 10 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
时间窗: 14 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
次要结局
- The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.(21 days)
- The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.(5 days)
- The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.(10 days)
- The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.(14 days)
研究者
Abdo Y Ismail
Post-graduate Periodontics Resident
University of Kentucky