Intra- and Post- Operative Bleeding After Simple Dental Extraction in Direct Oral Anticoagulant Therapy

• Conditions: Anticoagulant-induced Bleeding; Dental Diseases
• Interventions: Procedure: simple dental extraction

• Registration Number: NCT03124030
• Lead Sponsor: University of Trieste

Brief Summary

Direct Oral Anticoagulants were recently approved for medical treatment of several condition such as, non valvular atrial fibrillation, deep venous thrombosis, and others, substituting sometimes the conventional oral anticoagulants. The aim of the present study is to observe the possible difference in intra-operative and post-operative bleeding events for single dental extraction.

Detailed Description

Many protocols of drug suspension for surgical procedure has been designed, since the introduction of anticoagulant or antiplatelet medications. Nowadays it is not certain if suspension could give more costs than benefits for the surgical procedure itself. With the recent development of the Direct Oral Anticoagulant it is still unclear whether these medications might bring more bleeding events in the intra-operative and post-operative phase after oral surgery procedure, equal to, or more than Oral Anticoagulant Therapy. The purpose of this study is to assess the degree of intra- and post-operative bleeding complication between direct oral anticoagulant therapy patients and Oral Anticoagulant Therapy patients.

Study Timeline

• Study Start: 2016-08-02
• Study First Submitted: 2017-03-30
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Study First Posted: 2017-04-21
• Last Update Posted: 2017-04-21
• Primary Completion: 2017-11-15
• Study Completion: 2018-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Male and female patients at 20 or more years of age.
2. Healthy patients (≤ American Society of Anesthesiologists 3).
3. Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Dabigatran (PRADAXA), Rivaroxaban (XARELTO), Apixaban (ELIQUIS), Edoxaban (LIXIANA).
4. Indication for extraction of a single tooth.
5. No other contraindications for tooth extraction.
6. Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl.
7. Signed informed consent.

Exclusion Criteria

1. Smoke > 10 cigarettes per day.
2. Assumption of any antiplatelet medication.
3. Assumption of Heparin medication.
4. Assumption of oral anticoagulant medications (Warfarin, Coumadin).
5. Wash-out period after antiplatelet or Heparin medication at least 15 days.
6. Assumption of food or drugs that may alter direct oral anticoagulant blood values.
7. Uncontrolled Hypertension.
8. Uncontrolled Diabetes
9. Chronic Hepatitis and/or reduction of hepatic function
10. Coagulopathy (in excess of defect)
11. Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
12. Head and neck radiotherapy (previous 10 years).
13. Chemotherapy (previous 2 years).
14. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial.
15. Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism).
16. Pregnant or breastfeeding women.
17. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).

Oral Anticoagulant Therapy

Inclusion Criteria:

1. Male and female patients at 20 or more years of age.
2. General health status (< American society of anesthesiologist a 3).
3. Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Warfarin (COUMADIN), acenocoumarol (SINTROM).
4. Indication for extraction of a single tooth.
5. No contraindications for tooth extraction.
6. Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl.
7. International Normalized Ratio measured within 7 days prior to the procedure should between 2.0 and 3.0.
8. No diet changes within the week before blood sampling (avoiding interacting food)
9. Signed informed consent.

Exclusion Criteria:

1. Smoke > 10 cigarettes per day.
2. Assumption of any antiplatelet medication.
3. Assumption of any Heparin medication.
4. Assumption of any direct oral anticoagulant medication.
5. Uncontrolled Hypertension.
6. Uncontrolled Diabetes.
7. Chronic Hepatitis and/or reduction of hepatic function
8. Coagulopathy (in excess of defect)
9. Wash-out period after antiplatelet or Heparin medication at least 15 days.
10. Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
11. Assumption of food or drugs that may alter oral anticoagulant blood values.
12. Head and neck radiotherapy (previous 10 years).
13. Chemotherapy (previous 10 years).
14. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial.
15. Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism).
16. Pregnant or breastfeeding women.
17. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Direct Oral Anticoagulants	simple dental extraction	assuming Pradaxa or Apixaban or Eliquis; undergo simple dental extraction
Oral Anticoagulant therapy	simple dental extraction	assuming Coumadin or Sintrom; undergo simple dental extraction

Primary Outcome Measures

Name	Time	Method
post-operative bleeding complication	30 minutes	questionnaire is provided to the patient for bleeding characterization

Secondary Outcome Measures

Name	Time	Method
oral health status	1 week before	examination of the oral cavity, registration of periodontal indices
cardiological assessment	1 week before	registration of the Atrial Fibrillation Stroke Risk score
intra-operative bleeding	intra-operative	a standardized cotton roll is weighted after imbibition on the post-extractive alveolus for 20 seconds
bleeding risk assessment	1 week before	registration of the Score for Major Bleeding Risk score

Trial Locations

Locations (1)

Clinica Odontoiatrica e Stomatologica; 🇮🇹 Trieste, Italy