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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology
- Telefonnummer: (+84-28) 3855 8735
- E-mail: dtnhien.nt25@ump.edu.vn
Studiesteder
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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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Kontakt:
- Anh TN Nguyen, PhD
- Telefonnummer: +84-28 3855 9225
- E-mail: pkckrhm@ump.edu.vn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Early Implant Failure Rate
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Early Postoperative Infection Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Periodontale sygdomme
- Mundsygdomme
- Stomatognatiske sygdomme
- Postoperative komplikationer
- Patologiske processer
- Tandsygdomme
- Infektioner
- Sårinfektion
- Patologiske tilstande, tegn og symptomer
- Tandtab
- Kirurgisk sårinfektion
- Terapeutik
- Lægemiddelterapi
- Kemoprevention
- Premedikering
- Antibiotisk profylakse
Andre undersøgelses-id-numre
- 26723 - ĐHYD
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
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