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Not yet recruitingNCT07920614Updated Nov 5, 2026

Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study

An interventional study of Single-Implant Placement Without Antibiotic Prophylaxis in Tooth Loss and Rehabillitation, Dental Implant Failure and Surgical Wound Infection, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Not yet recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Other

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Tooth Loss and Rehabillitation
  • Dental Implant Failure
  • Surgical Wound Infection

Keywords

  • dental implant
  • single-tooth implant
  • antibiotic prophylaxis
  • early implant failure
  • surgical site infection
  • antimicrobial stewardship
03

In context

Tooth Loss

165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.

This study's planned enrollment of 39 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • 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

Exclusion criteria

Exclusion Criteria:

  • Immediate implant placement
  • Beta-lactam allergy
  • Systemic antibiotics within the previous 4 weeks
  • Long-term high-dose , or intravenous bisphosphonates
  • Poorly controlled diabetes ( above 7.5%)
  • Indication for mandatory antibiotic prophylaxis (high risk of infective endocarditis)
  • Pregnancy or breastfeeding
  • Current smoking or alcohol dependence
  • Poor oral hygiene or non-cooperation
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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Immunosuppression

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HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (estimated)

Study arms

  • Experimental
    Single Implant Placement Without Antibiotic Prophylaxis

    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.

    Procedure: Single-Implant Placement Without Antibiotic Prophylaxis

Interventions

  • ProcedureSingle-Implant Placement Without Antibiotic Prophylaxis

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month and 3 months after implant placement

Secondary outcomes

  1. 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.

    Time frame: Day 2, day 7, day 14, 1 month and 3 months after implant placement

  2. Postoperative Pain

    Pain intensity on a 0 to 10 visual analogue scale (0 = no pain, 10 = worst pain imaginable)

    Time frame: Day 2, day 7 after implant placement

  3. Ibuprofen Use After Surgery

    Total number of ibuprofen 400 mg tablets taken for pain after surgery

    Time frame: Day 7 after implant placement

  4. Peri-implant Soft-Tissue Status

    Modified sulcus bleeding index (mSBI), score 0 to 3

    Time frame: 1 month and 3 months after implant placement

07

Study locations

1 site
  • Odonto-Stomatology Clinic, University of Medicine and Pharmacy at Ho Chi Minh City
    Ho Chi Minh City, Vietnam
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07920614
Responsible party
Dang Tran Ngoc Hien (Resident Physician, Department of Oral Pathology, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
Nov 5, 2026
Start date
Nov 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology
Contact
dtnhien.nt25@ump.edu.vn
(+84-28) 3855 8735
Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology
principal investigator · University of Medicine and Pharmacy at Ho Chi Minh City

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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