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.
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.
Pathological condition requiring hospital refferal
Complications following re-surgery
Re-assesment of the diagnosis from the general dentist practicioner
Root fracture present.
The study participants * Will be reffered to the dental refferal clinic from private or community dental clinics from all over Sealand, Denmark. * will undergo surgery at the private refferal clinic in Roskilde or Copenhagen. * will have a 7-10 days follow-up
Cohort
Prospective
Not listed
Intraoperative and postoperative complications
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.
Intraoperative complications
The intraoperative complications are registered if: Unplanned tooth extraction/implant placement: another tooth removal/placement of implant than planned. Lack of primary stability: registered if the implant is mobile in the site of the osteotomy prior to placement. Root displacement: if the root is displaced to e.g. the sinus antrum, the mandibular canal or the floor of the month, requiring intervention. Root tip fracture: if not being removed during surgery. Maxillary sinus perforation: positive valsalva maneuver. Oro-antral communication: an opening between sinus maxillaris and the oral cavity confirmed by x-ray. Hemorrhage: if intervention during/after surgery required. Aspiration/ingestion: if aspiration/ingestion of a material during or after surgery.
Other intraoperative complications
Damage to adjacent structures: to teeth if loss of enamel/dentin correlated to surgical instruments, or devitalization. To bone if mandible/tuberosity fracture. Diagnosed by x-ray. To soft tissue, e.g. lacerations, if a dehiscence occur in the soft tissue. To chin/lips e.g. burns. To nerve, if macroscopic nerve damage or complete rupture.
Postoperative complications
Surgical site infection with or without abscess (SSI): is registered if the surgical region is erythematous, swollen and suppuration from the surgical wound occurs. It can be supplemented with extraoral edema and erythema. Additionally, trismus and dysphagia can present concomitant. The infection can be with abscess formation, which will be noted if a collection of suppuration is collected and limited to an adjacent area. Alveolar osteitis (AO): will be registered if the patient has increased pain on the 2-5. day after surgery. The pain is intense and can radiate to the ear. Clinically, the alveolus will be grey and empty, as well as sore if palpated. Halitose might be present as well. Continuous hemorrhage requiring intervention: if a bleeding occurs, that requires additional surgical intervention, e.g. surgicel, spongostan or drill on vessels. If postoperative bleeding can be either continuous or pulsing.
Postoperative complications
Periodontal pocket formation: is registered with a probe, and registered if CAL \>3mm from the enamel-cementum junction to the most apical point. Hematoma: an extravascular collection of blood caused by local anesthesia/surgical trauma. Osteomyelitis (acute/chronic): The chronic form occur \>4 weeks, and characterized with necrosis and infection of the bone, most often the mandible. The symptoms will be febrile condition, extraoral edema, swollen lymph nodes, pain in the area, suppuration with/without abscess formation and fistula. Necrotic bone sequestrum and paresthesia can be present as well. On a radiographic, the bone will have an osteolytic appearance. Prolonged pain or trismus \>1 week. Pain as subjective reported pain, and trismus if the jaw mobility is \<40mm. Neurosensory deficiency; an-, dys- or paresthesia. Registered if a complete loss, a painful or an altered sensitivity occurs. Dysgeusia might be present. The location depends on the nerve affected.
Questionnaire: State-Trait Anxiety Inventory short form (STAI-SF)
The State-Trait Anxiety Inventory short form (STAI-SF): will be registered by the standardized questionnaire. The replies is rated on a 4-point Likert scale, and a sum of scores is added, resulted in a score from 6-24. Positive items are reverse scored. Then the score is mulitplied with 20/6 to be comparable with the full STAI score. A higher score indicate a higher level of anxiety.
Questionnaire: International Positive and Negative Affect Schedule Short Form (I-PANAS-SF)
The PANAS: will be registered by the standardized questionnaire. The questionnaire measure two core dimensions of affect: the positive (PA) and negative affect (NA). There is 10 items in total, 5 PA and 5 NA respectively. The scale is rated on a 5 point Likert Scale. The resulting sum has a range of 5-25 for PA and NA respectively. A higher score indicate a higher PA and NA, which are separated construct, why the score can not be combined.
Surgeon assessment
On the day of surgery the surgeons will make an assessment of the patient, risk profile and evaluation. The questionnaire will include the following data: 1. An assessment of risk of complications on a Likert scale from 1-5 (from very little to very high risk) 2. An assessment of the peroperative compliance from 1: sufficient to 2: insufficient. 3. An assessment of the peroperative communication: 1: good level, 2: challenging communication. 4. An assessment of the difficulty of the surgery on a Likert Scale from 1-5. 5. A self-assessment of motivation during the surgery on a visual lineal scale from 0-100.
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University of Copenhagen
Lead sponsor
Specialtandlaegerne Sjaelland ApS
Collaborator
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