Tooth ExtractionNCT07913035
Post-extraction Bleeding in Older Adults on Uninterrupted Antiplatelet Therapy
An observational study of Tooth Extraction and Postoperative Hemorrhage, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This prospective, assessor-blinded, controlled observational study compares bleeding after simple tooth extraction between adults aged 40 years or older who continue their antiplatelet therapy (aspirin, clopidogrel or dual antiplatelet therapy) without interruption and controls taking no drug that affects haemostasis. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction, Postoperative Hemorrhage, Platelet Aggregation Inhibitors
- What is being tested?
- Antiplatelet therapy (uninterrupted) and Simple tooth extraction with stepwise local haemostatic protocol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2024to 30 Aug 2025
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 40 years or older with an indication for simple extraction of one to three teeth at the Department of Odonto-Stomatology, Ba Ria General Hospital, Vietnam: consecutive patients on uninterrupted antiplatelet therapy and controls taking no drug that affects haemostasis.
Who may be able to join
- Age 40 years or older
- Indication for simple (non-surgical) extraction of one to three teeth
- ASA physical status I or II
- APT group: taking aspirin, clopidogrel or dual antiplatelet therapy without interruption during the 7 days before extraction
- Control group: not taking any drug affecting haemostasis (vitamin K antagonists, direct oral anticoagulants, antiplatelet agents or non-steroidal anti-inflammatory drugs)
- Written informed consent
Who cannot join
- Self-discontinuation of antiplatelet therapy without medical advice
- Thrombocytopenia or other platelet disorders
- Inherited or acquired coagulopathies (e.g., haemophilia, von Willebrand disease, systemic lupus erythematosus)
- Current use of vitamin K antagonists or direct oral anticoagulants
- Severe hepatic disease or renal failure requiring dialysis
- Ongoing radiotherapy or chemotherapy
Show all 10Show fewer
- Acute infection at the extraction site
- Known allergy to any drug or material used in the study
- Inability to cooperate
- Conversion to surgical extraction or incomplete telephone follow-up (withdrawn from analysis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-extraction Bleeding in Older Adults on Uninterrupted Antiplatelet Therapy: A Prospective, Assessor-blinded, Controlled Observational Study
This prospective, assessor-blinded, controlled observational study compares bleeding after simple tooth extraction between adults aged 40 years or older who continue their antiplatelet therapy (aspirin, clopidogrel or dual antiplatelet therapy) without interruption and controls taking no drug that affects haemostasis. Socket bleeding is graded at 15, 30, 45 and 60 minutes within a stepwise local haemostatic protocol, and recurrent bleeding is monitored by telephone for 72 hours. The study also explores demographic, clinical and pharmacological factors associated with prolonged and recurrent bleeding among patients on antiplatelet therapy.
Read the detailed description
Patients receiving long-term antiplatelet therapy for cardiovascular or cerebrovascular disease increasingly require dental extractions. Guidelines recommend continuing antiplatelet therapy for low-bleeding-risk procedures, but prospective data from older Southeast Asian patients, among whom clopidogrel is widely prescribed, are lacking.
Consecutive eligible patients on uninterrupted antiplatelet therapy and controls frequency-matched for sex and tooth type are enrolled at the Department of Odonto-Stomatology, Ba Ria General Hospital, Vietnam. Before extraction, patients on antiplatelet therapy undergo a complete blood count, PT, INR and aPTT, and a cardiologist confirms that therapy should be continued. All simple extractions of one to three teeth are performed by one experienced oral surgeon under 2% lidocaine with 1:100,000 epinephrine (maximum two cartridges).
A blinded assessor grades socket bleeding as none, mild or severe at 15 (T1), 30 (T2), 45 (T3) and 60 (T4) minutes. Bleeding sockets are managed stepwise: gauze pressure until T2, a gelatin sponge at T2, and topical tranexamic acid with sutures at T3; persistent bleeding at T4 would prompt hospital observation. Recurrent bleeding after discharge is assessed by structured telephone interviews at 24, 48 and 72 hours. Groups are compared with Fisher's exact and Mann-Whitney U tests, and factors associated with prolonged and recurrent bleeding in the antiplatelet group are explored with Firth-penalised logistic regression.
- Being tested
- Antiplatelet therapy (uninterrupted), Simple tooth extraction with stepwise local haemostatic protocol
- Keywords
- antiplatelet therapy, dual antiplatelet therapy, clopidogrel, aspirin, post-extraction bleeding, hemostasis
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet therapy (uninterrupted)Drug
Also called Aspirin, Clopidogrel
Aspirin 81 mg/day, clopidogrel 75 mg/day, or aspirin 100 mg plus clopidogrel 75 mg/day (dual antiplatelet therapy), continued without interruption as prescribed by the patient's physician. Antiplatelet therapy is not assigned by the investigators.
Simple tooth extraction with stepwise local haemostatic protocolProcedure or surgery
Non-surgical extraction of one to three teeth by one experienced oral surgeon under 2% lidocaine with 1:100,000 epinephrine (maximum two cartridges), followed by gauze pressure; a gelatin sponge is placed at 30 minutes and topical tranexamic acid irrigation with sutures is applied at 45 minutes when bleeding persists.
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet therapy (APT) group | Adults aged 40 years or older taking aspirin, clopidogrel or dual antiplatelet therapy without interruption during the 7 days before simple extraction of one to three teeth. Receives: Drug: Antiplatelet therapy (uninterrupted); Procedure: Simple tooth extraction with stepwise local haemostatic protocol | |
| Control group | Adults aged 40 years or older taking no drug that affects haemostasis, recruited during the same period and frequency-matched to the APT group for sex and tooth type, undergoing simple extraction of one to three teeth. Receives: Procedure: Simple tooth extraction with stepwise local haemostatic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Sockets With Residual Bleeding at 15 Minutes
Socket bleeding is graded by a blinded assessor after gauze removal as none (no visible bleeding), mild (oozing without continuous flow) or severe (immediate, continuous flow). Residual bleeding is defined as mild or severe bleeding.
Measured: 15 minutes after tooth extraction
Proportion of Sockets With Residual Bleeding at 30 Minutes
Same three-level grading (none, mild, severe) after continued gauze pressure. Residual bleeding is defined as mild or severe bleeding.
Measured: 30 minutes after tooth extraction
Secondary outcomes (5)
Proportion of Sockets With Residual Bleeding at 45 and 60 Minutes
Same three-level grading after gelatin sponge placement (45 minutes) and after topical tranexamic acid irrigation with sutures (60 minutes).
Measured: 45 and 60 minutes after tooth extraction
Time to Haemostasis
Time from tooth delivery to the first assessment at which no bleeding is observed, in minutes.
Measured: Up to 60 minutes after tooth extraction
Most Advanced Local Haemostatic Measure Required
Proportion of visits managed with gauze pressure only, a gelatin sponge, or topical tranexamic acid with sutures.
Measured: Up to 60 minutes after tooth extraction
Recurrent Bleeding After Discharge
Any bleeding reported after discharge once haemostasis had been achieved, assessed by structured telephone interviews at 24, 48 and 72 hours; timing and management are recorded.
Measured: Up to 72 hours after tooth extraction
Factors Associated With Prolonged and Recurrent Bleeding in the Antiplatelet Therapy Group
Odds ratios from Firth-penalised logistic regression for age, sex, number of teeth extracted, extraction time, platelet count and antiplatelet regimen.
Measured: 30 minutes and 72 hours after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Sep 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- 210 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ba Ria General Hospital
- Responsible party
- Principal investigator, Son Hoang Le, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Son H Le, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913035
- Sponsor's protocol ID
- 1977/ĐHYD-HĐĐĐ
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-extraction Bleeding in Older Adults on Uninterrupted Antiplatelet Therapy: A Prospective, Assessor-blinded, Controlled Observational Study
- ClinicalTrials.gov ID
- NCT07913035
- Acronym / sponsor ID
- 1977/ĐHYD-HĐĐĐ
- Keywords
- antiplatelet therapy, dual antiplatelet therapy, clopidogrel, aspirin, post-extraction bleeding, hemostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Ba Ria General Hospital
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 3 Nov 2026 (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 prospective, assessor-blinded, controlled observational study compares bleeding after simple tooth extraction between adults aged 40 years or older who continue their antiplatelet therapy (aspirin, clopidogrel or dual antiplatelet therapy) without interruption and controls taking no drug that affects haemostasis. Socket bleeding is graded at 15, 30, 45 and 60 minutes within a stepwise local haemostatic protocol, and recurrent bleeding is monitored by telephone for 72 hours. The study also explores demographic, clinical and pharmacological factors associated with prolonged and recurrent bleeding among patients on antiplatelet therapy.
Detailed description
Patients receiving long-term antiplatelet therapy for cardiovascular or cerebrovascular disease increasingly require dental extractions. Guidelines recommend continuing antiplatelet therapy for low-bleeding-risk procedures, but prospective data from older Southeast Asian patients, among whom clopidogrel is widely prescribed, are lacking.
Consecutive eligible patients on uninterrupted antiplatelet therapy and controls frequency-matched for sex and tooth type are enrolled at the Department of Odonto-Stomatology, Ba Ria General Hospital, Vietnam. Before extraction, patients on antiplatelet therapy undergo a complete blood count, PT, INR and aPTT, and a cardiologist confirms that therapy should be continued. All simple extractions of one to three teeth are performed by one experienced oral surgeon under 2% lidocaine with 1:100,000 epinephrine (maximum two cartridges).
A blinded assessor grades socket bleeding as none, mild or severe at 15 (T1), 30 (T2), 45 (T3) and 60 (T4) minutes. Bleeding sockets are managed stepwise: gauze pressure until T2, a gelatin sponge at T2, and topical tranexamic acid with sutures at T3; persistent bleeding at T4 would prompt hospital observation. Recurrent bleeding after discharge is assessed by structured telephone interviews at 24, 48 and 72 hours. Groups are compared with Fisher's exact and Mann-Whitney U tests, and factors associated with prolonged and recurrent bleeding in the antiplatelet group are explored with Firth-penalised logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet therapy (APT) group | – | Drug: Antiplatelet therapy (uninterrupted), Procedure: Simple tooth extraction with stepwise local haemostatic protocolAdults aged 40 years or older taking aspirin, clopidogrel or dual antiplatelet therapy without interruption during the 7 days before simple extraction of one to three teeth. |
| Control group | – | Procedure: Simple tooth extraction with stepwise local haemostatic protocolAdults aged 40 years or older taking no drug that affects haemostasis, recruited during the same period and frequency-matched to the APT group for sex and tooth type, undergoing simple extraction of one to three teeth. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40 years or older with an indication for simple extraction of one to three teeth at the Department of Odonto-Stomatology, Ba Ria General Hospital, Vietnam: consecutive patients on uninterrupted antiplatelet therapy and controls taking no drug that affects haemostasis.
Key inclusion criteria (6 listed)
- Age 40 years or older
- Indication for simple (non-surgical) extraction of one to three teeth
- ASA physical status I or II
- APT group: taking aspirin, clopidogrel or dual antiplatelet therapy without interruption during the 7 days before extraction
- Control group: not taking any drug affecting haemostasis (vitamin K antagonists, direct oral anticoagulants, antiplatelet agents or non-steroidal anti-inflammatory drugs)
Key exclusion criteria (10 listed)
- Self-discontinuation of antiplatelet therapy without medical advice
- Thrombocytopenia or other platelet disorders
- Inherited or acquired coagulopathies (e.g., haemophilia, von Willebrand disease, systemic lupus erythematosus)
- Current use of vitamin K antagonists or direct oral anticoagulants
- Severe hepatic disease or renal failure requiring dialysis
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 |
|---|---|---|
| Antiplatelet therapy (uninterrupted)Also: Aspirin, ClopidogrelAspirin 81 mg/day, clopidogrel 75 mg/day, or aspirin 100 mg plus clopidogrel 75 mg/day (dual antiplatelet therapy), continued without interruption as prescribed by the patient's physician. Antiplatelet therapy is not assigned by the investigators. | Drug | Antiplatelet therapy (APT) group |
| Simple tooth extraction with stepwise local haemostatic protocolNon-surgical extraction of one to three teeth by one experienced oral surgeon under 2% lidocaine with 1:100,000 epinephrine (maximum two cartridges), followed by gauze pressure; a gelatin sponge is placed at 30 minutes and topical tranexamic acid irrigation with sutures is applied at 45 minutes when bleeding persists. | Procedure or surgery | Antiplatelet therapy (APT) group, Control group |
Primary outcome
Proportion of Sockets With Residual Bleeding at 15 Minutes
Time frame: 15 minutes after tooth extraction
Socket bleeding is graded by a blinded assessor after gauze removal as none (no visible bleeding), mild (oozing without continuous flow) or severe (immediate, continuous flow). Residual bleeding is defined as mild or severe bleeding.
Proportion of Sockets With Residual Bleeding at 30 Minutes
Time frame: 30 minutes after tooth extraction
Same three-level grading (none, mild, severe) after continued gauze pressure. Residual bleeding is defined as mild or severe bleeding.
5 secondary outcomes
Proportion of Sockets With Residual Bleeding at 45 and 60 Minutes
Time frame: 45 and 60 minutes after tooth extraction
Time to Haemostasis
Time frame: Up to 60 minutes after tooth extraction
Most Advanced Local Haemostatic Measure Required
Time frame: Up to 60 minutes after tooth extraction
Recurrent Bleeding After Discharge
Time frame: Up to 72 hours after tooth extraction
Factors Associated With Prolonged and Recurrent Bleeding in the Antiplatelet Therapy Group
Time frame: 30 minutes and 72 hours after tooth extraction
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided. De-identified data are available from the corresponding author on reasonable request.
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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.
Son H Le, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
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 Tooth Extraction and Postoperative Hemorrhage, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 6 inclusion and 10 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 3 Nov 2026. 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 Vietnam. 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?
Proportion of Sockets With Residual Bleeding at 15 Minutes (time frame: 15 minutes after tooth extraction). The study lists 2 primary outcomes in all. 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 3 Nov 2026.