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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology
- Telefoonnummer: (+84-28) 3855 8735
- E-mail: dtnhien.nt25@ump.edu.vn
Studie Locaties
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Ho Chi Minh City, Vietnam
- Odonto-Stomatology Clinic, University of Medicine and Pharmacy at Ho Chi Minh City
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Contact:
- Anh TN Nguyen, PhD
- Telefoonnummer: +84-28 3855 9225
- E-mail: pkckrhm@ump.edu.vn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Early Implant Failure Rate
Tijdsspanne: 1 month and 3 months after implant placement
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Early Postoperative Infection Rate
Tijdsspanne: Day 2, day 7, day 14, 1 month and 3 months after implant placement
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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
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Postoperative Pain
Tijdsspanne: Day 2, day 7 after implant placement
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Pain intensity on a 0 to 10 visual analogue scale (0 = no pain, 10 = worst pain imaginable) |
Day 2, day 7 after implant placement
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Ibuprofen Use After Surgery
Tijdsspanne: Day 7 after implant placement
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Total number of ibuprofen 400 mg tablets taken for pain after surgery |
Day 7 after implant placement
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Peri-implant Soft-Tissue Status
Tijdsspanne: 1 month and 3 months after implant placement
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Modified sulcus bleeding index (mSBI), score 0 to 3 |
1 month and 3 months after implant placement
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Parodontale aandoeningen
- Mondziekten
- Stomatognatische ziekten
- Postoperatieve complicaties
- Pathologische processen
- Tand ziekten
- Infecties
- Wond infectie
- Pathologische aandoeningen, tekenen en symptomen
- Tand verlies
- Chirurgische wondinfectie
- Therapeutica
- Drugstherapie
- Chemopreventie
- Premedicatie
- Antibiotische profylaxe
Andere studie-ID-nummers
- 26723 - ĐHYD
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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