Analysis of the Complications in Palatal Graft Harvesting With the UPV/EHU Technique vs. Single Incision Technique.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Post-surgical pain perception
研究概览
简要总结
Soft tissue defects can be a problem, especially in patients with high smile lines; in these clinical scenarios, the treatment with periodontal plastic surgery in combination with the use of a connective tissue graft (CTG) is considered the gold-standard procedure.
Single incision technique (Huerzeler & Weng, 1999) is one of the suggested procedures to harvest the CTG from palate. The UPV/EHU technique (Aguirre-Zorzano et al, 2017) showed less inflammation and post-surgical complications than trap-door technique, but also other technique should to be analysed.
However, there is still no consensus about which is the best technique to obtain this kind of graft. Therefore, clinicians should justify their choice based on the tissue's quality obtained and the patient's well-being, producing the least number of complications, such as inflammation, post-surgical pain, or recession in the donor area.
HYPOTHESIS:
Does the technique of obtaining an CTG of the palate using the "UPV/EHU technique" (Aguirre-Zorzano et al., 2017) result in a lower number of complications versus the "single incision technique" (Huerzeler & Weng, 1999)?
OBJECTIVES The main objective is to assess whether the complications occurring with the harvesting of the CTG using the "UPV/EHU technique" (Aguirre-Zorzano et al., 2017) are lower than with the "single incision technique"(Huerzeler & Weng, 1999), knowing the patient's perception of pain.
The secondary objectives are: a) necrosis of the palate, b) possible resulting recession in the donor area, and c) characteristics of the graft obtained
详细描述
Type of Study: randomized clinical trial
Two different treatments (UPV/EHU technique (test) (Aguirre-Zorzano et al. 2017) vs. Single Incision technique (control) (Huerzeler & Weng, 1999)) will be compared. These techniques are usually used to harvest a CTG from the palate.
Main outcome: complications in the donor area.
Follow-up: 6 months.
UNIT OF ANALYSIS: The patient of the Master's Degree in Periodontology and Osseointegration from the University of the Basque Country (UPV/EHU), requires treatment with a CTG harvested from the palate.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant: Initially, the subject will not know what technique has been received, the complete information regarding the surgical technique used, as the results obtained in his case, will be given in the last visit of the year.
Observer: Another periodoncist (R.E.), outside the intervention, would be in charge of recording the clinical parameters.
Analyst: The statistician (X.M.) does not know which treatment corresponds to each variable.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of the UPV/EHU university dental clinic who required a connective graft of the palate in their treatment.
- •Patients ≥ 18 years-old
- •Absence of active periodontal disease ( healthy periodontal patients or periodontal patients who had received active periodontal treatment, and now they are included in a tailored supportive periodontal program)
- •Full-mouth plaque index (FMPI) (O'Leary y cols. 1972) and full-mouth bleeding index (FMBI) (Ainamo y Bay, 1975) ≤ 25%
排除标准
- •Smokers of ≥ 10 cigarettes/day
- •Systemic conditions that contraindicated surgery
- •The use of analgesic and/or anti-inflammatory drugs in the last 72 h
- •The use of opioid drugs, anticonvulsants and/or antidepressants, except selective serotonin inhibitors, i.e., those drugs that act by reducing the painful experience
- •Pregnancy or nursing women
结局指标
主要结局
Post-surgical pain perception
时间窗: After surgery up to 14 days
The subject will we instructed to collect their perception of post-surgical pain in the VAS based on the UPV/EHU Pain diary (Fernandez-Jimenez et al, 2021). Specifically the subject will record: Its intensity (0-100mm), its duration (minutes or hours) and if any analgesic treatment has been necessary (No o Yes: Which?).
次要结局
- Length of the donor area of the palate and of the obtained CTG(mm)(Surgery)
- Extension of the bed recipient.(Baseline)
- Full mouth plaque index (FMPI).(Change from baseline at following surgery sixth month respectively.)
- Central Sensitization Inventory severity-level score of the subject Central Sensitization inventory (CSI) (Mayer et al. 2012)(Baseline)
- Pre-surgical pain perception.(Baseline)
- Post-surgical complications(After surgery first seven days.)
- Width of the donor area of the palate and of the obtained CTG (mm)(Surgery)
- Gingival recession (REC) in donor area(Change from baseline at following surgery sixth month respectively.)
- Thickness of the donor area of the palate and of the connective tissue graft(Surgery)
- Necrosis of the palate(up to 7 days post-srugery)
- Area (mm2) of the donor area of the palate and of the obtained CTG(Surgery)
- Full mouth bleeding index (FMBI) (Aynamo & Bay, 1975)(Change from baseline at following surgery sixth month respectively.)
- Probing depth (PD)(Change from baseline at following surgery sixth month respectively.)
研究者
Ana María García de la Fuente
Professor
University of the Basque Country (UPV/EHU)