Evaluation of the Intra- and Post- Operative Bleeding After Periodontal Debridement in Direct Anticoagulant Patients

Study Overview
=================
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 periodontal debridement.

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 clinical 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 periodontal causal therapy, 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 for periodontal debridement.

Official Title
-----------------
Evaluation of the Intra- and Post- Operative Bleeding After After Periodontal Debridement in Direct Oral Anticoagulation Patients: a Longitudinal Observational Cohort Study

Conditions
-----------------
Anticoagulant-induced Bleeding, Periodontal Diseases

Intervention / Treatment
-----------------
* Procedure: periodontal debridement


Participation Criteria
=================
Eligibility Criteria
-----------------
Direct Oral Anticoagulant Inclusion Criteria: Male and female patients at 20 or more years of age. Healthy patients (≤ American Society of Anesthesiologists 3). Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Dabigatran (PRADAXA), Rivaroxaban (XARELTO), Apixaban (ELIQUIS), Edoxaban (LIXIANA). Indication for extraction of a single tooth. No other contraindications for tooth extraction. Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl. Signed informed consent. Exclusion Criteria: Smoke > 10 cigarettes per day. Assumption of any antiplatelet medication. Assumption of Heparin medication. Assumption of oral anticoagulant medications (Warfarin, Coumadin). Wash-out period after antiplatelet or Heparin medication at least 15 days. Assumption of food or drugs that may alter direct oral anticoagulant blood values. Uncontrolled Hypertension. Uncontrolled Diabetes Chronic Hepatitis and/or reduction of hepatic function Coagulopathy (in excess of defect) Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure. Head and neck radiotherapy (previous 10 years). Chemotherapy (previous 2 years). Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial. Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism). Pregnant or breastfeeding women. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance). Oral Anticoagulant Therapy Inclusion Criteria: Male and female patients at 20 or more years of age. General health status (< American society of anesthesiologist a 3). Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Warfarin (COUMADIN), acenocoumarol (SINTROM). Indication for extraction of a single tooth. No contraindications for tooth extraction. Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl. International Normalized Ratio measured within 7 days prior to the procedure should between 2.0 and 3.0. No diet changes within the week before blood sampling (avoiding interacting food) Signed informed consent. Exclusion Criteria: Smoke > 10 cigarettes per day. Assumption of any antiplatelet medication. Assumption of any Heparin medication. Assumption of any direct oral anticoagulant medication. Uncontrolled Hypertension. Uncontrolled Diabetes. Chronic Hepatitis and/or reduction of hepatic function Coagulopathy (in excess of defect) Wash-out period after antiplatelet or Heparin medication at least 15 days. Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure. Assumption of food or drugs that may alter oral anticoagulant blood values. Head and neck radiotherapy (previous 10 years). Chemotherapy (previous 10 years). Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial. Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism). Pregnant or breastfeeding women. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Direct Oral Anticoagulants<br>assuming Pradaxa or Eliquis or Apixaban or Xarelto; undergoing periodontal debridement | Procedure: periodontal debridement<br>* with ultrasonic device supragingival and subgingival full-mouth debridement is provided<br>* Other names: subgingival scaling;|
| oral anticoagulant therapy<br>assuming Coumadin or Sintrom; undergoing periodontal debridement | Procedure: periodontal debridement<br>* with ultrasonic device supragingival and subgingival full-mouth debridement is provided<br>* Other names: subgingival scaling;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-operative bleeding | intra-operative bleeding is registered as follows: mild if stopped in 20 seconds; medium: if stopped after not more than one minute; severe: if not stopped. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative bleeding events | a questionnaire is given to the patient to register post-operative bleeding events | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
direct oral anticoagulant, oral anticoagulant therapy, periodontal disease, periodontal debridement, ultrasonic periodontal debridement, ultrasonic scaling, periodontal scaling, subgingival scaling