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

Sponsor

University of Trieste (Other)

Overall Status

Unknown status

CT.gov ID

NCT03124004

Collaborator

(none)

128

Enrollment

Location

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulant-induced Bleeding Periodontal Diseases	Procedure: 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

128 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 15, 2016

Anticipated Primary Completion Date :

Nov 15, 2017

Anticipated Study Completion Date :

Nov 15, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Direct Oral Anticoagulants

assuming Pradaxa or Eliquis or Apixaban or Xarelto; undergoing periodontal debridement

Procedure: periodontal debridement

with ultrasonic device supragingival and subgingival full-mouth debridement is provided

Other Names:

subgingival scaling

oral anticoagulant therapy

assuming Coumadin or Sintrom; undergoing periodontal debridement

Procedure: periodontal debridement

with ultrasonic device supragingival and subgingival full-mouth debridement is provided

Other Names:

subgingival scaling

Outcome Measures

Primary Outcome Measures

intra-operative bleeding [30 minutes]
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.

Secondary Outcome Measures

post-operative bleeding events [1 week]
a questionnaire is given to the patient to register post-operative bleeding events

Other Outcome Measures

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
bleeding risk assessment [1 week before]
registration of the Score for Major Bleeding Risk score

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).