Surgeons' Prediction of Dental Surgery Complications and the Influence of Patient Characteristics: Development of an AI Model

NCT07461324 | Not Yet Recruiting

• 1 other identifier: F-25043297
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postoperative Infections; Mandibular Nerve Injuries; Alveolar Osteitis; Complication; Dental Implantation; Tooth Extraction; Apical Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (5)

• 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

Other Outcomes (3)

• Questionnaire: State-Trait Anxiety Inventory short form (STAI-SF)

  The time frame for these observations are from baseline/Day 1: the day of surgery.

• Questionnaire: International Positive and Negative Affect Schedule Short Form (I-PANAS-SF)

  Baseline/Day 1: registered on the day of surgery

• Surgeon assessment

  Baseline/Day 1: on the day of surgery

Study Arms (3)

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Specialtandlaegerne Sjaelland ApS: collaborator

Study Sites (2)

University of Copenhagen

Copenhagen, 2200, Denmark

Location

Specialtandlægerne Sjælland

Roskilde, 4000, Denmark

Location

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Related Links

• Sundhedsstyrelsen, SST. "Nationale kliniske retningslinje for brug af antibiotika ved tandlaegebehandling", (2019). Assessed the 2. January 2026.
• National Cancer Institute. (n.d.). Complication. NCI Dictionary of Cancer Terms. Accessed 4. January 2026.
• Sundhedsstyrelsen, SST. "Anbefalinger om alkohol", (2025). Assessed the 2. January 2026.

MeSH Terms

Conditions

Mandibular Nerve Injuries; Dry Socket

Condition Hierarchy (Ancestors)

Trigeminal Nerve Injuries; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Esben Boeskov Øzhayat, DDS, Associate professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Simon Storgaard Jensen, OMFS, Professor, Dr. Odont.

  University of Copenhagen

  STUDY CHAIR

Central Study Contacts

Sofie Holmboe Dahl, P.h.D-student DDS/DMD Dentist

CONTACT

+45 28681630; zbr493@ku.dk

Morten Højte Dahl, DDS, Ph.d. degree and OMFS

CONTACT

+45 29254048; morten@spsj.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 10, 2026

Record last verified: 2025-07

Locations

DK (2)