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

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

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.

Study Overview

• Status: Unknown
• Conditions: Periodontal Diseases; Anticoagulant-induced Bleeding
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 128

Contacts and Locations

• Study Contact: Name: Roberto Di Lenarda, Prof.; Phone Number: 0039 0403992254; Email: rdilenarda@units.it

Study Locations

• Italy
  • Trieste, Italy, 34100
    • Recruiting
    • Clinica Odontoiatrica e Stomatologica
    • Contact: Roberto Di Lenarda, Prof.; Phone Number: 0039 0403992254; Email: rdilenarda@units.it
    • Sub-Investigator: Gaetano Castronovo, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cardiovascular patient assuming oral anticoagulant therapy (conventional or direct)

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral health status	examination of the oral cavity, registration of periodontal indices	1 week before
cardiological assessment	registration of the Atrial Fibrillation Stroke Risk score	1 week before
bleeding risk assessment	registration of the Score for Major Bleeding Risk score	1 week before

Collaborators and Investigators

• Sponsor: University of Trieste
• Investigators: Study Chair: Gaetano Castronovo, Dr., University of Trieste

Publications and helpful links

Helpful Links

• a discussion paper on clinical implications of oral anticoagulants

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Anticipated): November 15, 2017
• Study Completion (Anticipated): November 15, 2018

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: periodontal disease; direct oral anticoagulant; oral anticoagulant therapy; periodontal debridement; ultrasonic periodontal debridement; ultrasonic scaling; periodontal scaling; subgingival scaling
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Stomatognathic Diseases; Mouth Diseases; Hemorrhage; Periodontal Diseases; Postoperative Hemorrhage
• Other Study ID Numbers: NOADB_debridement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No