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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Wound Infection; Dental Implant Failure; Tooth Loss and Rehabillitation
• Intervention / Treatment: Procedure: Single-Implant Placement Without Antibiotic Prophylaxis

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology; Phone Number: (+84-28) 3855 8735; Email: dtnhien.nt25@ump.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Odonto-Stomatology Clinic, University of Medicine and Pharmacy at Ho Chi Minh City
    • Contact: Anh TN Nguyen, PhD; Phone Number: +84-28 3855 9225; Email: pkckrhm@ump.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• Pregnancy or breastfeeding
• Current smoking or alcohol dependence
• Poor oral hygiene or non-cooperation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month and 3 months after implant placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Day 2, day 7 after implant placement
Ibuprofen Use After Surgery	Total number of ibuprofen 400 mg tablets taken for pain after surgery	Day 7 after implant placement
Peri-implant Soft-Tissue Status	Modified sulcus bleeding index (mSBI), score 0 to 3	1 month and 3 months after implant placement

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Investigators: Principal Investigator: Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: surgical site infection; dental implant; antimicrobial stewardship; antibiotic prophylaxis; early implant failure; single-tooth implant
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Tooth Diseases; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Tooth Loss; Surgical Wound Infection; Therapeutics; Drug Therapy; Chemoprevention; Premedication; Antibiotic Prophylaxis
• Other Study ID Numbers: 26723 - ĐHYD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No