Tooth Loss and RehabillitationNCT07920614
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
A study testing Single-Implant Placement Without Antibiotic Prophylaxis in people with Tooth Loss and Rehabillitation and Dental Implant Failure, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This pilot study will examine whether a single dental implant can be placed safely without giving antibiotics before or after surgery in patients with straightforward cases in Vietnam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss and Rehabillitation, Dental Implant Failure, Surgical Wound Infection
- What is being tested?
- Single-Implant Placement Without Antibiotic Prophylaxis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteVietnam
- Study dates
- Nov 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- ASA physical status I or II
- Single missing posterior tooth with an indication for dental implant placement
- Straightforward case: sufficient bone volume, no bone graft or sinus lift, no complex soft-tissue procedure, bone density D2 or D3 (Misch)
- Periodontal disease treated and stable
- Written informed consent
Who cannot join
- Immediate implant placement
- Beta-lactam allergy
- Systemic antibiotics within the previous 4 weeks
- Long-term high-dose corticosteroids, immunosuppressants or intravenous bisphosphonates
- Poorly controlled diabetes (HbA1c above 7.5%)
- Indication for mandatory antibiotic prophylaxis (high risk of infective endocarditis)
Show all 9Show fewer
- Pregnancy or breastfeeding
- Current smoking or alcohol dependence
- Poor oral hygiene or non-cooperation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Odonto-Stomatology Clinic, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City
Anh TN Nguyen, PhD, +84-28 3855 9225, pkckrhm@ump.edu.vn
About this study
Official title: Safety Assessment of a No - Antibiotic - Prophylaxis Protocol for Single - Implant Placement in Straightforward Cases: A Pilot Study
This pilot study will examine whether a single dental implant can be placed safely without giving antibiotics before or after surgery in patients with straightforward cases in Vietnam. Adults who are generally healthy, have one missing back tooth, and have enough bone for an implant will have the implant placed with standard infection-control measures (antiseptic mouth rinse, a surgical guide, and ibuprofen for relieving the pain) but no preventive antibiotics. Antibiotics will be given only if an infection develops. Participants will be seen 2 days, 7 days, 14 days, 1 month and 3 months after surgery. The main outcome is early implant failure, meaning the implant is lost before the replacement tooth is fitted. We will also record infection, pain, painkiller use, and gum health around the implant. The study will enroll 39 participants at the dental specialty clinic of the University of Medicine and Pharmacy at Ho Chi Minh City.
- Being tested
- Single-Implant Placement Without Antibiotic Prophylaxis
- Keywords
- dental implant, single-tooth implant, antibiotic prophylaxis, early implant failure, surgical site infection, antimicrobial stewardship
- Medical subject headings
- Tooth Loss, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Implant Placement Without Antibiotic ProphylaxisProcedure or surgery
Single dental implant placement with standardised perioperative care (ibuprofen, chlorhexidine mouthrinse, povidone-iodine antisepsis, surgical guide) and no systemic antibiotic prophylaxis. Antibiotics are used only as rescue treatment for diagnosed infection.
| Study group | Role | What they receive |
|---|---|---|
| Single Implant Placement Without Antibiotic Prophylaxis | Experimental | Adults with one missing posterior tooth in a straightforward case receive a single dental implant placed with a tooth-supported surgical guide. No systemic antibiotic is given before or after surgery. Standardised care: ibuprofen 400 mg 1 hour before surgery; chlorhexidine 0.12 to 0.2% mouthrinse for 60 seconds; extraoral povidone-iodine 10% antisepsis. After surgery: ibuprofen 400 mg (9 tablets, up to three times daily, stopped when pain resolves) and gentle chlorhexidine 0.12% rinse on day 1. Systemic antibiotics (amoxicillin/clavulanate 1 g twice daily) are used only as rescue treatment if infection is diagnosed. Follow-up at day 2, day 7, day 14, 1 month and 3 months. Receives: Procedure: Single-Implant Placement Without Antibiotic Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Implant Failure Rate
Proportion of participants whose implant is lost before functional prosthetic loading (implant removed for mobility with infection, progressive bone loss, or no response to treatment), assessed by clinical and radiographic examination.
Measured: 1 month and 3 months after implant placement
Secondary outcomes (4)
Early Postoperative Infection Rate
Proportion of participants with early postoperative infection, defined as at least two of the following four signs: pus or fistula; fever 38°C or above; pain increasing after postoperative day 3; progressive or spreading swelling beyond the surgical area after day 3.
Measured: Day 2, day 7, day 14, 1 month and 3 months after implant placement
Postoperative Pain
Pain intensity on a 0 to 10 visual analogue scale (0 = no pain, 10 = worst pain imaginable)
Measured: Day 2, day 7 after implant placement
Ibuprofen Use After Surgery
Total number of ibuprofen 400 mg tablets taken for pain after surgery
Measured: Day 7 after implant placement
Peri-implant Soft-Tissue Status
Modified sulcus bleeding index (mSBI), score 0 to 3
Measured: 1 month and 3 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Loss and RehabillitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, exploratory pilot study. All participants undergo single-implant placement without antibiotic prophylaxis. Systemic antibiotics are given only as rescue treatment if infection is diagnosed.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dang Tran Ngoc Hien, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920614
- Sponsor's protocol ID
- 26723 - ĐHYD
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of the small sample size, the risk of re-identification of participants, and because data sharing is not part of the ethics-approved consent.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of a No - Antibiotic - Prophylaxis Protocol for Single - Implant Placement in Straightforward Cases: A Pilot Study
- ClinicalTrials.gov ID
- NCT07920614
- Acronym / sponsor ID
- 26723 - ĐHYD
- Keywords
- dental implant, single-tooth implant, antibiotic prophylaxis, early implant failure, surgical site infection, antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 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 pilot study will examine whether a single dental implant can be placed safely without giving antibiotics before or after surgery in patients with straightforward cases in Vietnam. Adults who are generally healthy, have one missing back tooth, and have enough bone for an implant will have the implant placed with standard infection-control measures (antiseptic mouth rinse, a surgical guide, and ibuprofen for relieving the pain) but no preventive antibiotics. Antibiotics will be given only if an infection develops. Participants will be seen 2 days, 7 days, 14 days, 1 month and 3 months after surgery. The main outcome is early implant failure, meaning the implant is lost before the replacement tooth is fitted. We will also record infection, pain, painkiller use, and gum health around the implant. The study will enroll 39 participants at the dental specialty clinic of the University of Medicine and Pharmacy at Ho Chi Minh City.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, exploratory pilot study. All participants undergo single-implant placement without antibiotic prophylaxis. Systemic antibiotics are given only as rescue treatment if infection is diagnosed.
| Arm | Type | Receives |
|---|---|---|
| Single Implant Placement Without Antibiotic Prophylaxis | Experimental | Procedure: Single-Implant Placement Without Antibiotic ProphylaxisAdults with one missing posterior tooth in a straightforward case receive a single dental implant placed with a tooth-supported surgical guide. No systemic antibiotic is given before or after surgery. Standardised care: ibuprofen 400 mg 1 hour before surgery; chlorhexidine 0.12 to 0.2% mouthrinse for 60 seconds; extraoral povidone-iodine 10% antisepsis. After surgery: ibuprofen 400 mg (9 tablets, up to three times daily, stopped when pain resolves) and gentle chlorhexidine 0.12% rinse on day 1. Systemic antibiotics (amoxicillin/clavulanate 1 g twice daily) are used only as rescue treatment if infection is diagnosed. Follow-up at day 2, day 7, day 14, 1 month and 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- ASA physical status I or II
- Single missing posterior tooth with an indication for dental implant placement
- Straightforward case: sufficient bone volume, no bone graft or sinus lift, no complex soft-tissue procedure, bone density D2 or D3 (Misch)
- Periodontal disease treated and stable
Key exclusion criteria (9 listed)
- Immediate implant placement
- Beta-lactam allergy
- Systemic antibiotics within the previous 4 weeks
- Long-term high-dose corticosteroids, immunosuppressants or intravenous bisphosphonates
- Poorly controlled diabetes (HbA1c above 7.5%)
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 |
|---|---|---|
| Single-Implant Placement Without Antibiotic ProphylaxisSingle dental implant placement with standardised perioperative care (ibuprofen, chlorhexidine mouthrinse, povidone-iodine antisepsis, surgical guide) and no systemic antibiotic prophylaxis. Antibiotics are used only as rescue treatment for diagnosed infection. | Procedure or surgery | Single Implant Placement Without Antibiotic Prophylaxis |
Primary outcome
Early Implant Failure Rate
Time frame: 1 month and 3 months after implant placement
Proportion of participants whose implant is lost before functional prosthetic loading (implant removed for mobility with infection, progressive bone loss, or no response to treatment), assessed by clinical and radiographic examination.
4 secondary outcomes
Early Postoperative Infection Rate
Time frame: Day 2, day 7, day 14, 1 month and 3 months after implant placement
Postoperative Pain
Time frame: Day 2, day 7 after implant placement
Ibuprofen Use After Surgery
Time frame: Day 7 after implant placement
Peri-implant Soft-Tissue Status
Time frame: 1 month and 3 months after implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of the small sample size, the risk of re-identification of participants, and because data sharing is not part of the ethics-approved consent.
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.
Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology 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?
A study testing Single-Implant Placement Without Antibiotic Prophylaxis in people with Tooth Loss and Rehabillitation and Dental Implant Failure, 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 9 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: opening soon, as of the sponsor's last update on 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology ((+84-28) 3855 8735, dtnhien.nt25@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Implant Failure Rate (time frame: 1 month and 3 months after implant placement). 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 5 Nov 2026.