Systematic Risk Assessment Prior to Oral Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Intraoperative and postoperative complications
研究概览
简要总结
The goal of this observational study is to learn how to better predict and prevent intra- and postoperative complications in oral surgery in adult patients referred for oral surgical procedures. The study aims to understand how accurately surgeons can foresee complications and which patient, tooth, and surgery related factors influence the outcomes.
The research questions are:
- What is the incidence of intra and postoperative complications in oral surgery?
- Which factors predict these complications, and how accurately can surgeons anticipate them?
- Can the development of an AI tool reduce postoperative complications?
Participants will:
- Receive standard oral surgery treatment at a private referral clinic (Specialtandlægerne Sjælland).
- Have clinical information collected about their procedure, medical history, and personal characteristics (including anxiety level).
- Conduct a short questionnaire, the STAI-6 and the I-PANAS-SF.
- Have the surgeon record their prediction of whether complications are expected.
- Be followed in the postoperative lapse to document whether complications occur after surgery.
详细描述
Objective Clinical decision-making is based on intuition and experience, patients value, and the biological plausibility supported by literature. Prior to oral surgery the surgeon must consider patient-related, surgical-related and tooth-related factors. It can be limited by human ability, which is why artificial intelligence is suggested to improve clinical decision-making. An assessment tool that predicts complications has not yet been established.
Aim This study aims to evaluate the incidence and predictors of intra- and postoperative complications and assess the surgeon's ability to foresee these events. The study aims to systematize predictable variables to create an artificial intelligence prediction model to assist the oral surgeon in clinical decision-making. The current study will describe the frequencies of complication at a private referral clinic, Specialtandlægerne Sjælland (SPSJ), and clarify the impact of the surgeon and patient as predictive variables. The study contributes to advancing the use of artificial intelligence with the aim of improving clinical outcomes for patients, reducing the occurrence of complications intra- and postoperatively as well as ease the work of the surgeon. The study can potentially provide information regarding optimizing treatment, prognosis, survival and success of oral surgery. In addition, the study will provide valuable information about the surgeon's predictive abilities, and the impact of the patient's anxiety level and personal characteristics on the outcome of successful treatment.
Background The current study will explore the most frequent surgical intervention at a referral dental clinic being third molar removal, apical root surgery and placement of dental implants. Complications can occur intra- and postoperatively and are rarely fatal but often disabling in the short- or longterm. Expected predictive variables will be reported. Sociodemographic factors, patient-related factors and surgeon-related factors will be reported in the same manner independently of the surgical procedure. Additionally, anatomic factors, pathological factors as well as factors related to surgical procedure might affect the risk of complications.
There is a lack of evidence in measuring surgeons' experience and the clinical impact of it as a predictive factor. Studies report a higher incidence of complications occurs for patients operated by less experienced surgeons, hereof an increased risk for alveolar nerve deficiency and postoperative pain. Contradictory, seniority did not impact operation time according to previous studies. Apical surgery requires special knowledge and skills. A study compared the pooled success rate between endodontists and oral and maxillofacial surgeons, with a slightly higher success rate from endodontists, but a greater confidence interval in the group of surgeons. The international team for implantology (ITI) consensus report 2019 states that the clinician constitutes a significant risk factor, however it is not included in the Simple-Advanced-Complex classification guideline due to lack of accuracy in its measure. The investigators will include the surgeon's risk assessment of complications, as well as a self assessment evaluation postoperatively.
Dental anxiety level can affect the postoperative recovery, have serious implications in clinical situations and is reported to impact the intraoperative difficulty. Anxiety can have different expressions, but an objective measure of anxiety is the Spielberger State-Trait Anxiety Inventory (STAI). Measuring the state anxiety prior to the surgery has not yet been examined in a dental referral clinic. This study will ask the patients to fill out the STAI-6 to measure state anxiety prior to the surgery. An association of negative affectivity (NA) and decreased oral health related quality of life has been found. NA is suggested to have influence on human experience and includes fear, anxiety, stress level, anger, guilt, hostility, irritability, being ashamed and jittery. Additionally, lack of compliance can delay implant treatment due to an indirect effect on the outcome. This study will elucidate the connection between NA, state anxiety and oral surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients reffered from a general dentist practicioner for the following surgeries: third molar removal, apicoectomy, dental implant placement.
- •Patients >15 years of age
- •A valid diagnosis prior to the surgery
- •Cases with fully completed questionnaires.
排除标准
- •Pathological condition requiring hospital refferal
- •Complications following re-surgery
- •Re-assesment of the diagnosis from the general dentist practicioner
- •Specific for apical surgery:
- •Root fracture present.
- •Buccal bone height <3mm.
- •Specific for third molar removal:
- •- if coronectomy is conducted instead of total root removal.
- •Specific for dental implant:
- •if an implant has been placed before in the same region of interest.
- •Health conditions were dental implants are contraindicated.
研究组 & 干预措施
Third molar surgery
The group consist of participants, who are included in the study, if they are referred from their general practicioner to the refferal dental clinic for a third molar removal.
The patient will have between 1-4 tooth removals depending on the indication. The patient will only be included if the indication for the surgery is assessed as the correct diagnosis by the oral surgeon.
Apicoectomy
The group consist of participants, who are included in the study, if they are referred from their general practicioner to the refferal dental clinic for an apicoectomy/root tip resection.
The patient will be included no matter what tooth or how many teeth that has to undergo surgery. The patient will only be included if the indication for the surgery is assessed as the correct diagnosis by the oral surgeon.
Dental implant
The group consist of participants, who are included in the study, if they are referred from their general practicioner to the refferal dental clinic for the placement of a dental implant.
The patient will be included no matter what tooth or how many teeth that has to be replaced. The patient will only be included if the indication for the surgery is assessed as the correct diagnosis by the oral surgeon.
Sometimes reconstruction of soft or hard tissue is necessary, and these cases will be included in the study.
结局指标
主要结局
Intraoperative and postoperative complications
时间窗: Baseline/Day 1: day of surgery. 1. Follow-up 7-10 days after surgery. Emergency follow-up: baseline and through study completion. Apical surgery: 2. follow-up 1 year. Dental implant: 2. follow-up. If sensory impairment 3. month follow-up and up to 1 year
Intraoperative and postoperative complications and to set up a prediction model. Intraoperatively: unplanned tooth extraction, damage to adjacent structures; injury to hard tissue (bone fracture), soft tissue (lacerations or burns), maxillary sinus perforation, macroscopic nerve injury/rupture, root displacement/root tip fracture, oroantral communication, root displacement, hemorrhage, aspiration or ingestion. Specific for dental implants: an unplanned implant placement or lack of osseointegration. Postoperatively: Surgical site infection (SSI) with or without abscess, alveolar osteitis (AO), hemorrhage, periodontal pocket formation (CAL), hematoma, osteomyelitis, prolonged pain or trismus (\>1week) or devitalization of neighboring teeth. Moreover neurosensory deficiency, bone fracture, oro-antral communication and hematoma can occur. For dental implants: loss of implant, exposure or rejection of biomaterial/transplant material and loss of cover screw are postoperative complications.
次要结局
- Intraoperative complications(Baseline/Day 1: day of surgery.)
- Other intraoperative complications(Baseline/Day 1: day of surgery.)
- Postoperative complications(1. Follow-up 7-10 days after surgery. Emergency follow-up: baseline and through study completion.)
- Postoperative complications(1. Follow-up 7-10 days after surgery. Emergency follow-up: baseline and through study completion. Apical surgery: 2. follow-up 1 year. Dental implant: 2. follow-up. If sensory impairment 3. month follow-up and up to 1 year)
- Postoperative complications specific for dental implants(1. Follow-up 7-10 days after surgery. Emergency follow-up: baseline and through study completion. Dental implant: 2. follow-up according to loading protocol (see detailed description). If sensory impairment 3. month follow-up and up to 1 year)
