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

NCT03124004 | Unknown

• 1 other identifier: NOADB_debridement
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• post-operative bleeding events

  1 week

Other Outcomes (3)

• oral health status

  1 week before

• cardiological assessment

  1 week before

• bleeding risk assessment

  1 week before

Study Arms (2)

Direct Oral Anticoagulants

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

Procedure: periodontal debridement

oral anticoagulant therapy

assuming Coumadin or Sintrom; undergoing periodontal debridement

Procedure: periodontal debridement

Interventions

periodontal debridement PROCEDURE

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

Also known as: subgingival scaling

Direct Oral Anticoagulants; oral anticoagulant therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cardiovascular patient assuming oral anticoagulant therapy (conventional or direct)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Clinica Odontoiatrica e Stomatologica

Trieste, 34100, Italy

RECRUITING

Related Links

• a discussion paper on clinical implications of oral anticoagulants

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Periodontal Debridement; Dental Scaling

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry

Study Officials

• Roberto Di Lenarda, Prof.

  University of Trieste

  PRINCIPAL INVESTIGATOR

• Federico Berton, Dr.

  University of Trieste

  STUDY DIRECTOR

• Fulvia Costantinides, Dr.

  University of Trieste

  STUDY CHAIR

• Gaetano Castronovo, Dr.

  University of Trieste

  STUDY CHAIR

Central Study Contacts

Roberto Di Lenarda, Prof.

CONTACT

0403992254; rdilenarda@units.it

Federico Berton, Dr.

CONTACT

0403992020; fberton@units.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 21, 2017
• Study Start: August 15, 2016
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2018
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)