Anticoagulant-induced BleedingNOADB_dbNCT03124004
Evaluation of the Intra- and Post- Operative Bleeding After Periodontal Debridement in Direct Anticoagulant Patients
An observational study of Anticoagulant-induced Bleeding and Periodontal Diseases, run by University of Trieste at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anticoagulant-induced Bleeding, Periodontal Diseases
- What is being tested?
- periodontal debridement
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 15 Aug 2016to 15 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiovascular patient assuming oral anticoagulant therapy (conventional or direct)
Who may be able to join
- 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.
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- Signed informed consent.
- Male and female patients at 20 or more years of age.
- General health status (< American society of anesthesiologist a 3).
- Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Warfarin (COUMADIN), acenocoumarol (SINTROM).
- Indication for extraction of a single tooth.
- No contraindications for tooth extraction.
- Accepted platelet count within 7 days prior to the procedure has to be > 50000 mg/dl.
- International Normalized Ratio measured within 7 days prior to the procedure should between 2.0 and 3.0.
- No diet changes within the week before blood sampling (avoiding interacting food)
- Signed informed consent.
Who cannot join
- 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.
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- 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).
- Pregnant or breastfeeding women.
- Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).
- Oral Anticoagulant Therapy
- Smoke > 10 cigarettes per day.
- Assumption of any antiplatelet medication.
- Assumption of any Heparin medication.
- Assumption of any direct oral anticoagulant medication.
- Uncontrolled Hypertension.
- Uncontrolled Diabetes.
- Chronic Hepatitis and/or reduction of hepatic function
- Coagulopathy (in excess of defect)
- Wash-out period after antiplatelet or Heparin medication at least 15 days.
- Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
- Assumption of food or drugs that may alter oral anticoagulant blood values.
- Head and neck radiotherapy (previous 10 years).
- Chemotherapy (previous 10 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).
- Pregnant or breastfeeding women.
- Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Clinica Odontoiatrica e Stomatologica
Trieste, 34100
Roberto Di Lenarda, Prof., 0403992254 ext. 0039, rdilenarda@units.it
Federico Berton, Dr., 0403992020 ext. 0039, fberton@units.it
About this study
Official title: 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.
Read the 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.
- Being tested
- periodontal debridement
- Keywords
- direct oral anticoagulant, oral anticoagulant therapy, periodontal disease, periodontal debridement, ultrasonic periodontal debridement, ultrasonic scaling, periodontal scaling, subgingival scaling
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal debridementProcedure or surgery
Also called subgingival scaling
with ultrasonic device supragingival and subgingival full-mouth debridement is provided
| Study group | Role | What they receive |
|---|---|---|
| Direct Oral Anticoagulants | assuming Pradaxa or Eliquis or Apixaban or Xarelto; undergoing periodontal debridement Receives: Procedure: periodontal debridement | |
| oral anticoagulant therapy | assuming Coumadin or Sintrom; undergoing periodontal debridement Receives: Procedure: periodontal debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
post-operative bleeding events
a questionnaire is given to the patient to register post-operative bleeding events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start15 Aug 2016
- Primary completion15 Nov 2017 (estimated)
- Study completion15 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulant-induced BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. Roberto Di Lenarda, University of Trieste
- Investigators
- Roberto Di Lenarda, Prof., Principal investigator, University of TriesteFederico Berton, Dr., Study director, University of TriesteFulvia Costantinides, Dr., Study chair, University of TriesteGaetano Castronovo, Dr., Study chair, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124004
- Sponsor's protocol ID
- NOADB_debridement
- Acronym
- NOADB_db
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intra- and Post- Operative Bleeding After After Periodontal Debridement in Direct Oral Anticoagulation Patients: a Longitudinal Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03124004
- Acronym / sponsor ID
- NOADB_db / NOADB_debridement
- Keywords
- direct oral anticoagulant, oral anticoagulant therapy, periodontal disease, periodontal debridement, ultrasonic periodontal debridement, ultrasonic scaling, periodontal scaling, subgingival scaling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 15 Nov 2017 (estimated)
- Study completion
- 15 Nov 2018 (estimated)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Oral Anticoagulants | – | Procedure: periodontal debridementassuming Pradaxa or Eliquis or Apixaban or Xarelto; undergoing periodontal debridement |
| oral anticoagulant therapy | – | Procedure: periodontal debridementassuming Coumadin or Sintrom; undergoing periodontal debridement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiovascular patient assuming oral anticoagulant therapy (conventional or direct)
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal debridementAlso: subgingival scalingwith ultrasonic device supragingival and subgingival full-mouth debridement is provided | Procedure or surgery | Direct Oral Anticoagulants, oral anticoagulant therapy |
Primary outcome
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.
1 secondary outcome
post-operative bleeding events
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- a discussion paper on clinical implications of oral anticoagulantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Di Lenarda, Prof. principal investigator
University of Trieste
Federico Berton, Dr. study director
University of Trieste
Fulvia Costantinides, Dr. study chair
University of Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulant-induced Bleeding and Periodontal Diseases, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Di Lenarda, Prof. (0403992254 ext. 0039, rdilenarda@units.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-operative bleeding (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.