Oral Anticoagulant TherapyNCT04846114
Dental Implants in Patients Under Oral Anticoagulant Therapy
A study testing Dental implant surgery in people with Oral Anticoagulant Therapy, run by Jorge Ernesto Aguilar at 1 site in Argentina.
Trial summary
This study evaluated the outcomes in the post-operative recovery following dental implant surgery in patients who continued on oral anticoagulated therapy (OAT) with warfarin. The primary outcome of this study was to evaluate bleeding within the first 5 days post-surgery and presence of intraoral/extraoral hematomas… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Anticoagulant Therapy
- What is being tested?
- Dental implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2016to Jun 2019
- Phase
- Interventional
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects:
- Systemically healthy.
- Healthy periodontal tissues or well-controlled periodontal health.
- In need of a maximum of two dental implants per hemiarcade,
- Showing ≥8mm bone height and ≥6 horizontal bone width.
- Needing a maximum of two surgical procedures.
- Who had written consent from the referring service to undergo the surgical procedure.
Who cannot join
- Subjects:
- Requiring implant placement immediately after extraction.
- Systemic disease contraindicating implant surgery.
- Mental disability preventing them from complying with the protocol.
- Hematological, metabolic, autoimmune or bone diseases.
- Hepatic alterations or receiving medication affecting liver function.
Show all 11Show fewer
- Receiving corticoid therapy, chemotherapy, or anticoagulant therapy within 10 days prior to the surgery.
- Taking antibiotics that interact with oral anticoagulants.
- Requiring vertical or periosteal incisions.
- Requiring bone regeneration strategy.
- When treatment involved placing an implant in more than one hemiarcade, the corresponding surgeries were scheduled 30 days apart.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association
Buenos Aires, 1125
About this study
Official title: Efficacy of Local Hemostatic Management in Implant Surgery in Anticoagulated Patients on Warfarin: a Randomized Clinical Study
This study evaluated the outcomes in the post-operative recovery following dental implant surgery in patients who continued on oral anticoagulated therapy (OAT) with warfarin. The primary outcome of this study was to evaluate bleeding within the first 5 days post-surgery and presence of intraoral/extraoral hematomas in skin and mucosa oral.
Read the detailed description
The aim of this study was compare: 1) the frequency of immediate and short term postoperative bleeding using tranexamic acid (TXAg), bismuth subgallate (BSg) or dry gauze (DGg) as local hemostatic 2) explore the relation between bleeding and the occurrence of hematomas, with length of incision, duration of surgery, and alveolar ridge recontouring. 80 surgical procedures performed in a total of 71 patients (20 surgical procedures in 18 patients not on OAT and 60 surgical procedures performed in 53 patients on OAT) that were assigned to one of four groups, so that each group included 20 procedures. The control group (Cg) comprised 20 procedures performed in patients not on OAT. The 60 procedures to be performed in patients on OAT were randomly to one of the three following experimental groups: 1) TXAg group, OAT plus TXA as local hemostatic agent; 2) BSg group, OAT plus BS as local hemostatic agent; 3) DGg group, OAT plus compression with dry gauze as local hemostatic agent. Outcomes variables were:
Intraoperative variables: length of incision expressed (Li) alveolar ridge recontouring (Arr), total duration of surgery (Ds), surgical quadrant and implant location.
Postoperative variables: immediate postoperative bleeding (within the first 30 minutes after surgery), short-term bleeding: within the first 5 days post-surgery, determined according to the index described by Bacci, presence of intraoral/extraoral hematomas in skin or mucosa. Descriptive statistical, analysis of variance and regression logistic analysis was performed. Statistical significance was set at a value of p<0.05.
- Conditions
- Oral Anticoagulant Therapy
- Being tested
- Dental implant surgery
- Keywords
- Dental Implants, Anticoagulant Therapy, Warfarin, Tranexamic Acid, Bismuth subgallate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group (Cg) | Active comparator | The control group (Cg) comprised 20 procedures performed in patients not on OAT.
Buccal and palatal-lingual flaps were repositioned and sutured with simple stitches using 5/0 monofilament nylon yarn, and a dry gauze was applied for 30 minutes. Receives: Procedure: Dental implant surgery |
| Tranexamic acid group (TXAg) | Experimental | TXAg group comprised 20 procedures performed in patients OAT. Buccal and palatal-lingual flaps were repositioned and sutured as in the Cg plus compression on the wound for 30 minutes using a gauze soaked in the contents of a 500mg ampoule of TXA, after which a new gauze soaked in the contents of a 500mg ampoule of TXA was applied for two hours. Receives: Procedure: Dental implant surgery |
| Bismuth subgallate group (BSg) | Experimental | BSg group comprised 20 procedures performed in patients OAT. At the moment of surgery, the contents of an anestube (1.8 ml) were mixed with a sufficient amount of BS powder to obtain a paste similar in consistency to tooth-paste (29). A thin layer of the paste was applied on the bone ridge, and buccal and palatal-lingual flaps were then repositioned and sutured as in the Cg. compression on the wound with a dry gauze for 30 minutes, after which a new dry gauze was placed for another two hours. Receives: Procedure: Dental implant surgery |
| Dry gauze group (DGg) | Experimental | DGg group comprised 20 procedures performed in patients OAT. Buccal and palatal-lingual flaps were repositioned and sutured as in the Cg plus compression on the wound with a dry gauze for 30 minutes, after which a new dry gauze was placed for another two hours. Receives: Procedure: Dental implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of immediate postoperative bleeding events
0: no bleeding; -1: mild bleeding defined as minor oozing from the wound incision controlled with compressive gauze only -2: moderate bleeding associated with the presence of large clots continuously disrupting the surgical area and requiring additional hemostatic measures; -3: severe bleeding requiring further medical control of coagulation
Measured: Within the first 30 minutes after surgery
Number of short-term bleeding events
0: no bleeding; -1: mild bleeding defined as minor oozing from the wound incision controlled with compressive gauze only -2: moderate bleeding associated with the presence of large clots continuously disrupting the surgical area and requiring additional hemostatic measures; -3: severe bleeding requiring further medical control of coagulation
Measured: Within the first 5 days post-surgery
Number of presence of intraoral hematomas events
changes in mucosa color and edema (recorded as a dichotomous variable- yes/no).
Measured: On day 7 post-surgery
Number of presence of extraoral hematomas events
changes in skin color and edema (recorded as a dichotomous variable- yes/no).
Measured: On day 7 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study startMar 2016
- Primary completionDec 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Oral Anticoagulant TherapyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 surgical procedures (pr) in 71 patients (18 not OAT/53 on OAT) were assigned to one of four groups: control group (Cg n=20 pr not OAT) and 3 experimental groups of patients on OAT with local hemostatic management were randomized: tranexamic acid group (TXAg n=20 pr), bismuth subgallate group (BSg n=20 pr) and dry gauze group (DGg n=20 pr).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jorge Ernesto Aguilar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Ernesto Aguilar, Universidad del Salvador, Argentina
- Investigators
- Jorge Aguilar, Chair Prof, Study director, Universidad del SalvadorMariano Vassallo, Assoc Prof, Principal investigator, Universidad del SalvadorJose Zamberlin, Assoc Prof, Principal investigator, Universidad del SalvadorMarina Diaz Roig, Assist Prof, Principal investigator, Universidad del SalvadorRicardo Macchi, Chair Prof, Study chair, University of Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846114
- Sponsor's protocol ID
- VRID 1500
- Status last verified
- Oct 2022
- First submitted
- 11 Apr 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keeling D, Baglin T, Tait C, Watson H, Perry D, Baglin C, Kitchen S, Makris M; British Committee for Standards in Haematology. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol. 2011 Aug;154(3):311-24. doi: 10.1111/j.1365-2141.2011.08753.x. Epub 2011 Jun 14. No abstract available.
PubMed 21671894van Diermen DE, van der Waal I, Hoogvliets MW, Ong FN, Hoogstraten J. Survey response of oral and maxillofacial surgeons on invasive procedures in patients using antithrombotic medication. Int J Oral Maxillofac Surg. 2013 Apr;42(4):502-7. doi: 10.1016/j.ijom.2012.09.018. Epub 2012 Nov 2.
PubMed 23123097Caliskan M, Tukel HC, Benlidayi ME, Deniz A. Is it necessary to alter anticoagulation therapy for tooth extraction in patients taking direct oral anticoagulants? Med Oral Patol Oral Cir Bucal. 2017 Nov 1;22(6):e767-e773. doi: 10.4317/medoral.21942.
PubMed 29053656Madrid C, Sanz M. What influence do anticoagulants have on oral implant therapy? A systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:96-106. doi: 10.1111/j.1600-0501.2009.01770.x.
PubMed 19663955Mehra P, Cottrell DA, Bestgen SC, Booth DF. Management of heparin therapy in the high-risk, chronically anticoagulated, oral surgery patient: a review and a proposed nomogram. J Oral Maxillofac Surg. 2000 Feb;58(2):198-202. doi: 10.1016/s0278-2391(00)90339-2.
PubMed 10670599George C, Barras M, Coombes J, Winckel K. Unfractionated heparin dosing in obese patients. Int J Clin Pharm. 2020 Apr;42(2):462-473. doi: 10.1007/s11096-020-01004-5. Epub 2020 Mar 5.
PubMed 32140914Daniels PR. Peri-procedural management of patients taking oral anticoagulants. BMJ. 2015 Jul 14;351:h2391. doi: 10.1136/bmj.h2391.
PubMed 26174061Halpern LR, Adams DR, Clarkson E. Treatment of the Dental Patient with Bleeding Dyscrasias: Etiologies and Management Options for Surgical Success in Practice. Dent Clin North Am. 2020 Apr;64(2):411-434. doi: 10.1016/j.cden.2019.12.010. Epub 2020 Jan 31.
PubMed 32111278Dewan K, Bishop K, Muthukrishnan A. Management of patients on warfarin by general dental practitioners in South West Wales: continuing the audit cycle. Br Dent J. 2009 Feb 28;206(4):E8; discussion 214-5. doi: 10.1038/sj.bdj.2009.112. Epub 2009 Feb 13.
PubMed 19214196Suresh V, Bishawi M, Manning MW, Patel C, Rogers J, Milano C, Schroder J, Daneshmand M, Powers D. Management of Patients With Left Ventricular Assist Devices Requiring Teeth Extraction: Is Halting Anticoagulation Appropriate? J Oral Maxillofac Surg. 2018 Sep;76(9):1859-1863. doi: 10.1016/j.joms.2017.10.022. Epub 2017 Oct 31.
PubMed 29156176Kammerer PW, Frerich B, Liese J, Schiegnitz E, Al-Nawas B. Oral surgery during therapy with anticoagulants-a systematic review. Clin Oral Investig. 2015 Mar;19(2):171-80. doi: 10.1007/s00784-014-1366-3. Epub 2014 Nov 22.
PubMed 25413495Lopez MA, Andreasi Bassi M, Confalone L, Gaudio RM, Lombardo L, Lauritano D. Clinical outcome of 215 transmucosal implants with a conical connection: a retrospective study after 5-year follow-up. J Biol Regul Homeost Agents. 2016 Apr-Jun;30(2 Suppl 1):55-60.
PubMed 27469549Ascani A, Iorio A, Agnelli G. Withdrawal of warfarin after deep vein thrombosis: effects of a low fixed dose on rebound thrombin generation. Blood Coagul Fibrinolysis. 1999 Jul;10(5):291-5.
PubMed 10456621Doonquah L, Mitchell AD. Oral surgery for patients on anticoagulant therapy: current thoughts on patient management. Dent Clin North Am. 2012 Jan;56(1):25-41, vii. doi: 10.1016/j.cden.2011.06.002.
PubMed 22117941Garcia DA, Regan S, Henault LE, Upadhyay A, Baker J, Othman M, Hylek EM. Risk of thromboembolism with short-term interruption of warfarin therapy. Arch Intern Med. 2008 Jan 14;168(1):63-9. doi: 10.1001/archinternmed.2007.23.
PubMed 18195197
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Local Hemostatic Management in Implant Surgery in Anticoagulated Patients on Warfarin: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04846114
- Acronym / sponsor ID
- VRID 1500
- Conditions
- Oral Anticoagulant Therapy
- Keywords
- Dental Implants, Anticoagulant Therapy, Warfarin, Tranexamic Acid, Bismuth subgallate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Jorge Ernesto AguilarUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 15 Apr 2021 (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.
This study evaluated the outcomes in the post-operative recovery following dental implant surgery in patients who continued on oral anticoagulated therapy (OAT) with warfarin. The primary outcome of this study was to evaluate bleeding within the first 5 days post-surgery and presence of intraoral/extraoral hematomas in skin and mucosa oral.
Detailed description
The aim of this study was compare: 1) the frequency of immediate and short term postoperative bleeding using tranexamic acid (TXAg), bismuth subgallate (BSg) or dry gauze (DGg) as local hemostatic 2) explore the relation between bleeding and the occurrence of hematomas, with length of incision, duration of surgery, and alveolar ridge recontouring. 80 surgical procedures performed in a total of 71 patients (20 surgical procedures in 18 patients not on OAT and 60 surgical procedures performed in 53 patients on OAT) that were assigned to one of four groups, so that each group included 20 procedures. The control group (Cg) comprised 20 procedures performed in patients not on OAT. The 60 procedures to be performed in patients on OAT were randomly to one of the three following experimental groups: 1) TXAg group, OAT plus TXA as local hemostatic agent; 2) BSg group, OAT plus BS as local hemostatic agent; 3) DGg group, OAT plus compression with dry gauze as local hemostatic agent. Outcomes variables were:
Intraoperative variables: length of incision expressed (Li) alveolar ridge recontouring (Arr), total duration of surgery (Ds), surgical quadrant and implant location.
Postoperative variables: immediate postoperative bleeding (within the first 30 minutes after surgery), short-term bleeding: within the first 5 days post-surgery, determined according to the index described by Bacci, presence of intraoral/extraoral hematomas in skin or mucosa. Descriptive statistical, analysis of variance and regression logistic analysis was performed. Statistical significance was set at a value of p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 80 surgical procedures (pr) in 71 patients (18 not OAT/53 on OAT) were assigned to one of four groups: control group (Cg n=20 pr not OAT) and 3 experimental groups of patients on OAT with local hemostatic management were randomized: tranexamic acid group (TXAg n=20 pr), bismuth subgallate group (BSg n=20 pr) and dry gauze group (DGg n=20 pr).
| Arm | Type | Receives |
|---|---|---|
| Control group (Cg) | Active comparator | Procedure: Dental implant surgeryThe control group (Cg) comprised 20 procedures performed in patients not on OAT. Buccal and palatal-lingual flaps were repositioned and sutured with simple stitches using 5/0 monofilament nylon yarn, and a dry gauze was applied for 30 minutes. |
| Tranexamic acid group (TXAg) | Experimental | Procedure: Dental implant surgeryTXAg group comprised 20 procedures performed in patients OAT. Buccal and palatal-lingual flaps were repositioned and sutured as in the Cg plus compression on the wound for 30 minutes using a gauze soaked in the contents of a 500mg ampoule of TXA, after which a new gauze soaked in the contents of a 500mg ampoule of TXA was applied for two hours. |
| Bismuth subgallate group (BSg) | Experimental | Procedure: Dental implant surgeryBSg group comprised 20 procedures performed in patients OAT. At the moment of surgery, the contents of an anestube (1.8 ml) were mixed with a sufficient amount of BS powder to obtain a paste similar in consistency to tooth-paste (29). A thin layer of the paste was applied on the bone ridge, and buccal and palatal-lingual flaps were then repositioned and sutured as in the Cg. compression on the wound with a dry gauze for 30 minutes, after which a new dry gauze was placed for another two hours. |
| Dry gauze group (DGg) | Experimental | Procedure: Dental implant surgeryDGg group comprised 20 procedures performed in patients OAT. Buccal and palatal-lingual flaps were repositioned and sutured as in the Cg plus compression on the wound with a dry gauze for 30 minutes, after which a new dry gauze was placed for another two hours. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Systemically healthy.
- Healthy periodontal tissues or well-controlled periodontal health.
- In need of a maximum of two dental implants per hemiarcade,
- Showing ≥8mm bone height and ≥6 horizontal bone width.
- Needing a maximum of two surgical procedures.
Key exclusion criteria (11 listed)
- Requiring implant placement immediately after extraction.
- Systemic disease contraindicating implant surgery.
- Mental disability preventing them from complying with the protocol.
- Hematological, metabolic, autoimmune or bone diseases.
- Hepatic alterations or receiving medication affecting liver function.
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 |
|---|---|---|
| Dental implant surgery | Procedure or surgery | Bismuth subgallate group (BSg), Control group (Cg), Dry gauze group (DGg), Tranexamic acid group (TXAg) |
Primary outcome
Number of immediate postoperative bleeding events
Time frame: Within the first 30 minutes after surgery
0: no bleeding; -1: mild bleeding defined as minor oozing from the wound incision controlled with compressive gauze only -2: moderate bleeding associated with the presence of large clots continuously disrupting the surgical area and requiring additional hemostatic measures; -3: severe bleeding requiring further medical control of coagulation
Number of short-term bleeding events
Time frame: Within the first 5 days post-surgery
0: no bleeding; -1: mild bleeding defined as minor oozing from the wound incision controlled with compressive gauze only -2: moderate bleeding associated with the presence of large clots continuously disrupting the surgical area and requiring additional hemostatic measures; -3: severe bleeding requiring further medical control of coagulation
Number of presence of intraoral hematomas events
Time frame: On day 7 post-surgery
changes in mucosa color and edema (recorded as a dichotomous variable- yes/no).
Number of presence of extraoral hematomas events
Time frame: On day 7 post-surgery
changes in skin color and edema (recorded as a dichotomous variable- yes/no).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background: PubMed 21671894Keeling D, Baglin T, Tait C, Watson H, Perry D, Baglin C, Kitchen S, Makris M; British Committee for Standards in Haematology. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol. 2011 Aug;154(3):311-24. doi: 10.1111/j.1365-2141.2011.08753.x. Epub 2011 Jun 14. No abstract available.
- Results publication: PubMed 23123097van Diermen DE, van der Waal I, Hoogvliets MW, Ong FN, Hoogstraten J. Survey response of oral and maxillofacial surgeons on invasive procedures in patients using antithrombotic medication. Int J Oral Maxillofac Surg. 2013 Apr;42(4):502-7. doi: 10.1016/j.ijom.2012.09.018. Epub 2012 Nov 2.
- Results publication: PubMed 29053656Caliskan M, Tukel HC, Benlidayi ME, Deniz A. Is it necessary to alter anticoagulation therapy for tooth extraction in patients taking direct oral anticoagulants? Med Oral Patol Oral Cir Bucal. 2017 Nov 1;22(6):e767-e773. doi: 10.4317/medoral.21942.
- Results publication: PubMed 19663955Madrid C, Sanz M. What influence do anticoagulants have on oral implant therapy? A systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:96-106. doi: 10.1111/j.1600-0501.2009.01770.x.
- Results publication: PubMed 10670599Mehra P, Cottrell DA, Bestgen SC, Booth DF. Management of heparin therapy in the high-risk, chronically anticoagulated, oral surgery patient: a review and a proposed nomogram. J Oral Maxillofac Surg. 2000 Feb;58(2):198-202. doi: 10.1016/s0278-2391(00)90339-2.
- Results publication: PubMed 32140914George C, Barras M, Coombes J, Winckel K. Unfractionated heparin dosing in obese patients. Int J Clin Pharm. 2020 Apr;42(2):462-473. doi: 10.1007/s11096-020-01004-5. Epub 2020 Mar 5.
- Results publication: PubMed 26174061Daniels PR. Peri-procedural management of patients taking oral anticoagulants. BMJ. 2015 Jul 14;351:h2391. doi: 10.1136/bmj.h2391.
- Results publication: PubMed 32111278Halpern LR, Adams DR, Clarkson E. Treatment of the Dental Patient with Bleeding Dyscrasias: Etiologies and Management Options for Surgical Success in Practice. Dent Clin North Am. 2020 Apr;64(2):411-434. doi: 10.1016/j.cden.2019.12.010. Epub 2020 Jan 31.
- Results publication: PubMed 19214196Dewan K, Bishop K, Muthukrishnan A. Management of patients on warfarin by general dental practitioners in South West Wales: continuing the audit cycle. Br Dent J. 2009 Feb 28;206(4):E8; discussion 214-5. doi: 10.1038/sj.bdj.2009.112. Epub 2009 Feb 13.
- Results publication: PubMed 29156176Suresh V, Bishawi M, Manning MW, Patel C, Rogers J, Milano C, Schroder J, Daneshmand M, Powers D. Management of Patients With Left Ventricular Assist Devices Requiring Teeth Extraction: Is Halting Anticoagulation Appropriate? J Oral Maxillofac Surg. 2018 Sep;76(9):1859-1863. doi: 10.1016/j.joms.2017.10.022. Epub 2017 Oct 31.
- Results publication: PubMed 25413495Kammerer PW, Frerich B, Liese J, Schiegnitz E, Al-Nawas B. Oral surgery during therapy with anticoagulants-a systematic review. Clin Oral Investig. 2015 Mar;19(2):171-80. doi: 10.1007/s00784-014-1366-3. Epub 2014 Nov 22.
- Results publication: PubMed 27469549Lopez MA, Andreasi Bassi M, Confalone L, Gaudio RM, Lombardo L, Lauritano D. Clinical outcome of 215 transmucosal implants with a conical connection: a retrospective study after 5-year follow-up. J Biol Regul Homeost Agents. 2016 Apr-Jun;30(2 Suppl 1):55-60.
- 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.
Jorge Aguilar, Chair Prof study director
Universidad del Salvador
Mariano Vassallo, Assoc Prof principal investigator
Universidad del Salvador
Jose Zamberlin, Assoc Prof principal investigator
Universidad del Salvador
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant surgery in people with Oral Anticoagulant Therapy, run by Jorge Ernesto Aguilar at 1 site in Argentina.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 12 Oct 2022. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of immediate postoperative bleeding events (time frame: Within the first 30 minutes after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846114, which also lists 48 linked publications.
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 12 Oct 2022.