Surgery, OralNCT04662515
NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications
An observational study of Surgery, Oral and Hemorrhage, run by Malmö University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Oral, Hemorrhage, Postoperative Complications
- What is being tested?
- Type of surgery, Dabigatran and Rivaroxaban
- Type of treatment
- Surgery or procedure
- How many people
- 216 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jun 2016to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Need of dental extraction / oral surgery, and medication with:
- warfarin or
- DOACs or
- no treatment or AK-platelet therapy and age-matched to group a) and b).
Who cannot join
- Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Skåne University Hospital
Helsingborg, SE - 251 87
Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University
Malmö, S-20506
About this study
Official title: Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications
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.
Read more
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.
Read the 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.
- Conditions
- Surgery, Oral, Hemorrhage, Postoperative Complications, Oral Surgical Procedures, Anticoagulants Causing Adverse Effects in Therapeutic Use, Anticoagulant-induced Bleeding
- Being tested
- Type of surgery, Dabigatran, Rivaroxaban, Apixaban, Edoxaban
- Medical subject headings
- Hemorrhage, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of surgeryProcedure or surgery
surgical or non-surgical extraction one or more teeth
DabigatranDrug
RivaroxabanDrug
ApixabanDrug
EdoxabanDrug
WarfarinDrug
| Study group | Role | What they receive |
|---|---|---|
| DOAC | Information about which type of DOAC and the dose that is prescribed to the patient will be collected. Receives: Procedure: Type of surgery; Drug: Dabigatran; Drug: Rivaroxaban; Drug: Apixaban; Drug: Edoxaban | |
| Warfarin | A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion. Receives: Procedure: Type of surgery; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding complication
proportion of patients who are in need of non planned/emergency medical or dental care after tooth extraction / oral surgery because of bleeding
Measured: 4 weeks postoperatively
Secondary outcomes (4)
bleeding volume
the amount of blood that the patient is bleeding during tooth extraction / oral surgery
Measured: the actual time of surgery
surgical difficulty
estimation on a scale of 1-10 by the surgeon
Measured: the actual time of surgery
surgery time in minutes
Measured: the actual time of surgery
proportion of other postoperative complications
Measured: 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Jun 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Principal investigator, Krister Johansson, Malmö University
- Investigators
- Jonas P becktor, DDS, PhD, Study director, Faculty of Odontology, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662515
- Sponsor's protocol ID
- AK-BLD
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2020
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Johansson K, Becktor JP, Naimi-Akbar A, Svensson PJ, Gotrick B. Continuous use of direct oral anticoagulants during and after simple and surgical tooth extractions: a prospective clinical cohort study. BMC Oral Health. 2025 Apr 12;25(1):554. doi: 10.1186/s12903-025-05949-9.
PubMed 40221663
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications
- ClinicalTrials.gov ID
- NCT04662515
- Acronym / sponsor ID
- AK-BLD
- Conditions
- Surgery, Oral, Hemorrhage, Postoperative Complications, Oral Surgical Procedures, Anticoagulants Causing Adverse Effects in Therapeutic Use, Anticoagulant-induced Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOAC | – | Procedure: Type of surgery, Drug: Dabigatran, Drug: Rivaroxaban, Drug: Apixaban, Drug: EdoxabanInformation about which type of DOAC and the dose that is prescribed to the patient will be collected. |
| Warfarin | – | Procedure: Type of surgery, Drug: WarfarinA PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- warfarin or
- DOACs or
- no treatment or AK-platelet therapy and age-matched to group a) and b).
Key exclusion criteria (1 listed)
- Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of surgerysurgical or non-surgical extraction one or more teeth | Procedure or surgery | DOAC, Warfarin |
| Dabigatran | Drug | DOAC |
| Rivaroxaban | Drug | DOAC |
| Apixaban | Drug | DOAC |
| Edoxaban | Drug | DOAC |
| Warfarin | Drug | Warfarin |
Primary outcome
bleeding complication
Time frame: 4 weeks postoperatively
proportion of patients who are in need of non planned/emergency medical or dental care after tooth extraction / oral surgery because of bleeding
4 secondary outcomes
bleeding volume
Time frame: the actual time of surgery
surgical difficulty
Time frame: the actual time of surgery
surgery time in minutes
Time frame: the actual time of surgery
proportion of other postoperative complications
Time frame: 4 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 40221663Johansson K, Becktor JP, Naimi-Akbar A, Svensson PJ, Gotrick B. Continuous use of direct oral anticoagulants during and after simple and surgical tooth extractions: a prospective clinical cohort study. BMC Oral Health. 2025 Apr 12;25(1):554. doi: 10.1186/s12903-025-05949-9.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas P becktor, DDS, PhD study director
Faculty of Odontology, Malmö University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, Oral and Hemorrhage, run by Malmö University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding complication (time frame: 4 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.