Clinical trial NCT03124004: Evaluation of the Intra- and Post- Operative Bleeding After Periodontal Debridement in Direct Anticoagulant Patients
Official title: Evaluation of the Intra- and Post- Operative Bleeding After After Periodontal Debridement in Direct Oral Anticoagulation Patients: a Longitudinal Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulant-induced Bleeding
Periodontal Diseases
Keywords: direct oral anticoagulant
oral anticoagulant therapy
periodontal disease
periodontal debridement
ultrasonic periodontal debridement
ultrasonic scaling
periodontal scaling
subgingival scaling
Lead sponsor: University of Trieste
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 128
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiovascular patient assuming oral anticoagulant therapy (conventional or direct)

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.

Eligibility criteria: Direct Oral Anticoagulant

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).

Primary outcomes:
measure: intra-operative bleeding
timeFrame: 30 minutes
Secondary outcomes:
measure: post-operative bleeding events
timeFrame: 1 week
Other outcomes:
measure: oral health status
timeFrame: 1 week before
measure: cardiological assessment
timeFrame: 1 week before
measure: bleeding risk assessment
timeFrame: 1 week before
Locations:
city: Trieste
country: Italy
facility: Clinica Odontoiatrica e Stomatologica
Study officials:
affiliation: University of Trieste
name: Roberto Di Lenarda, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Trieste
name: Federico Berton, Dr.
role: STUDY_DIRECTOR
affiliation: University of Trieste
name: Fulvia Costantinides, Dr.
role: STUDY_CHAIR
affiliation: University of Trieste
name: Gaetano Castronovo, Dr.
role: STUDY_CHAIR
References: