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

Periodontal Diseases Clinical Trial

— NOADB_db  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03124004
• Other study ID #: NOADB_debridement
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2017
• Last updated: April 18, 2017
• Start date: August 15, 2016
• Est. completion date: November 15, 2018

Study information

• Verified date: April 2017
• Source: University of Trieste
• Contact: Roberto Di Lenarda, Prof.
• Phone: 0403992254
• Email: rdilenarda[@]units.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Gingival Diseases
• Hemorrhage
• Periodontal Diseases
• Postoperative Hemorrhage

Intervention

Procedure:
• periodontal debridement
with ultrasonic device supragingival and subgingival full-mouth debridement is provided

Locations

Country	Name	City	State
Italy	Clinica Odontoiatrica e Stomatologica	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	oral health status	examination of the oral cavity, registration of periodontal indices	1 week before
Other	cardiological assessment	registration of the Atrial Fibrillation Stroke Risk score	1 week before
Other	bleeding risk assessment	registration of the Score for Major Bleeding Risk score	1 week before
Primary	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	post-operative bleeding events	a questionnaire is given to the patient to register post-operative bleeding events	1 week

External Links

•   a discussion paper on clinical implications of oral anticoagulants