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The effect of systemic antibiotics on post-surgical complications and patient-centered outcomes in patients undergoing implant surgery with guided bone regeneration and simultaneous sinus floor elevation

The effect of systemic antibiotics on post-surgical complications and patient-centered outcomes in patients undergoing implant surgery with guided bone regeneration and simultaneous sinus floor elevation

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220816003
Enrollment
30
Registered
2022-08-16
Start date
2022-08-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Potential benefit of antibiotic prophylaxis in dental implant placement with maxillary augmentation (Lateral approach) Dental implant, Lateral window sinus floor elevation, Guided bone regeneration, Patient-reported outcome, Complication, Systemic antibiotics, Antibiotic resistance

Interventions

Administration 2g PO of amoxicillin 1 hour before the surgery, 500 mg 8 hrs after surgery and 500 mg thrice daily on (1x3) on day 1-3 following the day of surgery. ,Administration 2g PO of placebo (n
Active Comparator Drug,Placebo Comparator Drug
Amoxicillin 500mg,Placebo 500mg

Sponsors

International team for implantology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to No maximum

Inclusion criteria

Inclusion criteria: Medically healthy adult (ASA I-II) Non-smoker or Light smoker with Not allergic to Amoxicillin, Penicillin, NSAIDS or corn-starch Edentulous spaces in the posterior maxilla No of signs of pathology of maxillary sinus Requiring 1 to 3 dental implants at posterior maxilla with simultaneous LWSFE

Exclusion criteria

Exclusion criteria: Medically compromised subjects ASA III-V General contraindications against implant treatment or augmentative procedures Taking oral Bisphosphonates longer than 5 years,Anti-angiogenic, RANKL-inhibitor medications or receiving local radiotherapy Heavy smoker or previous heavy smoker Allergic to Amoxicillin, Penicillin, NSAIDS or corn-starch Use of any form of antibiotics in the last 3 months or requiring regular antibiotic prophylaxis Pregnant or breastfeeding Acute symptomatic sinusitis Need immediate implant placement following extraction Need for simultaneous soft tissue augmentation Residual crest height > 5mm

Design outcomes

Primary

MeasureTime frame
Patient reported outcome measurement 1-14 days after the intervention Questionnaire (VAS score)—

Secondary

MeasureTime frame
Post-operative complication 2week, 1 month,4 month after surgery Questionnaire (Present/Absent)—

Countries

Thailand

Contacts

Public ContactSutinee Tangamnuay

Faculty of dentistry, Chulalongkorn university

aommmiiieee@hotmail.com0959596405

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026