Clinical trial NCT04662515: NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications
Official title: Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery, Oral
Hemorrhage
Postoperative Complications
Oral Surgical Procedures
Anticoagulants Causing Adverse Effects in Therapeutic Use
Anticoagulant-induced Bleeding
Lead sponsor: Malmö University
Sponsor class: OTHER
Collaborators: name: Odontologisk Forskning i Region Skåne (OFRS)
First posted: 2020-12-10
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to either the oral surgery department at Skåne University hospital or the department for Oral surgery and oral medicine, Malmö University.

The plan is to ask all patients consecutively referred to the clinics for participation.

Brief summary: Aims: To investigate the incidence of bleeding complications during oral surgical procedures in patients medicated with DOACs.

To investigate the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs.

To examine whether increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.

Previous studies have shown that the incidence of healthcare-consuming bleeding complications following oral surgical procedures in patients who are prescribed warfarin is approximately 4% (9). To investigate whether the incidence is higher or lower by the intake of DOAC it is considered to be sufficient with 100 patients in each group. The groups consist of patients who are prescribed warfarin, DOACs, as well as a control group.

Hypothetical outcomes: The incidence of bleeding complications and the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs are higher compared to patients medicated with warfarin and patients taking no anticoagulants. Increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.

Clinical relevance: The study will serve as a basis for the development of treatment guidelines for patients who medicate with DOACs. If it turns out that the oral surgery procedure presents no increased risk of complications and that the bleeding volume does not complicate the surgery significantly, it may be recommended that patients who medicate with DOACs whom are in need of oral surgical procedures seek ordinary dental care.

Detailed description: The continuous variables (amount of bleeding during surgery) will be analyzed with linear regression if they show normal distribution patterns.

The ordinal variables (postoperative bleeding complications) will be analyzed with ordinal logistic regression.

Dichotomous variables (presence of other postoperative complications) will be analyzed with logistic regression.

Eligibility criteria: Inclusion Criteria:

Need of dental extraction / oral surgery, and medication with:

1. warfarin or
2. DOACs or
3. no treatment or AK-platelet therapy and age-matched to group a) and b).

Exclusion Criteria:

Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse

Primary outcomes:
measure: bleeding complication
timeFrame: 4 weeks postoperatively
Secondary outcomes:
measure: bleeding volume
timeFrame: the actual time of surgery
measure: surgical difficulty
timeFrame: the actual time of surgery
measure: surgery time in minutes
timeFrame: the actual time of surgery
measure: proportion of other postoperative complications
timeFrame: 4 weeks postoperatively
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Skåne University Hospital
city: Malmö
country: Sweden
facility: Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University
Study officials:
affiliation: Faculty of Odontology, Malmö University
name: Jonas P becktor, DDS, PhD
role: STUDY_DIRECTOR
References: