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

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ClinicalTrials.gov Identifier: NCT03124004
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
prof. Roberto Di Lenarda, University of Trieste

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
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 Type : Observational
Estimated 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 : August 15, 2016
Estimated Primary Completion Date : November 15, 2017
Estimated Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: subgingival scaling




Primary Outcome Measures :
  1. intra-operative bleeding [ Time Frame: 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 :
  1. post-operative bleeding events [ Time Frame: 1 week ]
    a questionnaire is given to the patient to register post-operative bleeding events


Other Outcome Measures:
  1. oral health status [ Time Frame: 1 week before ]
    examination of the oral cavity, registration of periodontal indices

  2. cardiological assessment [ Time Frame: 1 week before ]
    registration of the Atrial Fibrillation Stroke Risk score

  3. bleeding risk assessment [ Time Frame: 1 week before ]
    registration of the Score for Major Bleeding Risk score



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cardiovascular patient assuming oral anticoagulant therapy (conventional or direct)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124004


Contacts
Contact: Roberto Di Lenarda, Prof. 0403992254 ext 0039 rdilenarda@units.it
Contact: Federico Berton, Dr. 0403992020 ext 0039 fberton@units.it

Locations
Italy
Clinica Odontoiatrica e Stomatologica Recruiting
Trieste, Italy, 34100
Contact: Roberto Di Lenarda, Prof.    0403992254 ext 0039    rdilenarda@units.it   
Contact: Federico Berton, Dr.    0403992020 ext 0039    fberton@units.it   
Sub-Investigator: Fulvia Costantinides, Dr.         
Sub-Investigator: Gaetano Castronovo, Dr.         
Sponsors and Collaborators
University of Trieste
Investigators
Principal Investigator: Roberto Di Lenarda, Prof. University of Trieste
Study Director: Federico Berton, Dr. University of Trieste
Study Chair: Fulvia Costantinides, Dr. University of Trieste
Study Chair: Gaetano Castronovo, Dr. University of Trieste

Additional Information:
Responsible Party: prof. Roberto Di Lenarda, Prof., University of Trieste
ClinicalTrials.gov Identifier: NCT03124004     History of Changes
Other Study ID Numbers: NOADB_debridement
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by prof. Roberto Di Lenarda, University of Trieste:
direct oral anticoagulant
oral anticoagulant therapy
periodontal disease
periodontal debridement
ultrasonic periodontal debridement
ultrasonic scaling
periodontal scaling
subgingival scaling

Additional relevant MeSH terms:
Hemorrhage
Periodontal Diseases
Gingival Diseases
Postoperative Hemorrhage
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Postoperative Complications
Anticoagulants