Wound Healing Following Palatal Graft Harvest Using Two Surgical Protocols - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Postoperative pain as evaluated by subjects using the Visual Analogue Scale
研究概览
简要总结
When harvesting autogenous free grafts to treat periodontal conditions (e.g., lack of attached keratinized tissue, ridge defects, and other mucogingival deformities), the hard palate is the preferred donor site. The primary disadvantage of this technique is the creation of a second surgical site. This sacrificial traumatic lesion on the palate is associated with significant post-operative morbidities, including patient discomfort, infection, inflammation, hemorrhage, and necrosis.
A pilot, blinded Randomized Control Trial will be conducted with subjects who are treatment planned to receive free gingival graft palatal harvest surgery. The palatal wound donor site for treatment group 1 will not receive an allograft membrane; while the donor site for treatment group 2 will receive an amnion-chorion allograft membrane (BioXclude) secured with a suture.
The severity of pain at the palatal wound site will be assessed using an at home survey (Visual Analog Scale, Pain Catastrophizing Scale, & Patient-Reported Outcomes Measurement Information System Scale). The healing of the palatal donor site will be evaluated quantitatively and qualitatively (PVS impression, optical scan, endoscopy, and ultrasnonography).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Twenty subjects (20) requiring mucogingival surgery and palatal graft harvest will be recruited into study.
The randomization will be achieved by preparing 20 envelopes, 10 envelopes containing materials for the palatal wound treatment #1 (empty packaging materials) and 10 envelopes containing materials for palatal wound treatment #2 (BioXclude membrane & suture). A blinded study team member will randomly hand the designated cohort allocation materials to the periodontology resident preforming the palatal wound dressing treatment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 18 and above
- •No reported systemic disease that would compromise healing, such as Diabetes with A1c level >7.0%, endocrine disorders, hypertension above Stage II based on AHA 2017, osteoporosis, or immunodeficiency
- •Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy.
- •Clinical indication for periodontal mucogingival surgery utilizing palatal graft harvest e.g., shallow palatal vaults classified by Reiser et al. (1996) the average distance as 7 mm from the CEJ of maxillary teeth to the neurovascular bundle
- •No history of previous palatal harvesting
排除标准
- •Pregnancy [confirmed via patient self-identification]
- •Systemic condition requiring antibiotic prophylaxis prior to any invasive procedure. The list of such conditions includes:
- •Prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts
- •Prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords.
- •Previous infective endocarditis
- •Unrepaired cyanotic congenital heart disease or repaired congenital heart disease, with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or prosthetic device.
- •Cardiac transplant with valve regurgitation due to a structurally abnormal valve.
- •Uncontrolled systemic disease e.g., Diabetes with A1c level > 7.0% endocrine disorders, hypertension above Stage II based on AHA 2017, osteoporosis, or immunodeficiency)
- •Use of medications, such as Dilantin (aka Phenytoin), Cyclosporin, and Nifedipin, that would adversely affect periodontal tissues
研究组 & 干预措施
Sutures
Patients assigned to Sutures group will not have the allograft placed on the donor site. One current clinical standard of practice is to place sutures on donor site. Patients assigned to Sutures group will have sutures placed on donor site.
干预措施: Sutures (Procedure)
Allograft and Sutures
Patients assigned to Allograft and Sutures will have allograft placed and secured with sutures on the donor site.
干预措施: amnion-chorion membrane (Device)
结局指标
主要结局
Postoperative pain as evaluated by subjects using the Visual Analogue Scale
时间窗: 60 days
The primary purpose of this study is to determine patient-reported outcome measures (i.e., pain) during the immediate post-operative period (i.e., 60 days). The Visual Analogue Scale survey will be completed by the patients during clinical visits and remotely. The scale ranges from a score of 0 to 10, with a higher score corresponding to more severe pain experienced post-op.
次要结局
- Wound volumetric changes(60 days)
- Patient satisfaction as evaluated by Visual Analogue Scale(60 days)
- Pain management (medication usage)(60 days)
- Pain Catastrophizing Scale (PCS)(60 days)
- • Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a(60 days)
研究者
Chia-Yu Chen
principla investigator
Harvard School of Dental Medicine