The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

NCT03412305 | Completed Phase 4 DMC

• 1 other identifier: AB-IMP
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to investigate whether routine administration of antibiotic prophylaxis 1 hour prior to implant surgery may prevent postoperative infection and implant loss in healthy or substantially healthy patients (ASA Class 1 and Class 2).

Conditions

Infection Control; Antibiotic Prophylaxis

Keywords

Dental implants, antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Implant failure

  Early implant mobility and/or infection, which requires the implant to be removed.

  3-6 months after implant placement

Secondary Outcomes (2)

• Postoperative infection

  7-14 days after implant placement

• Infection

  3-6 months after implant placement

Study Arms (2)

Amoxicillin oral tablets

ACTIVE COMPARATOR

2 g amoxicillin tablets orally 1 hour before implant placement

Drug: Amoxicillin

Placebo

PLACEBO COMPARATOR

Placebo tablets orally 1 hour before implant placement

Other: Placebo

Interventions

Amoxicillin DRUG

Antibiotic prophylaxis consisting of 4 amoxicillin tablets, totally 2 g, orally 1 hour before implant placement

Also known as: Amoxicillin oral tablets

Amoxicillin oral tablets

Placebo OTHER

Placebo consisting of 4 tablets, orally 1 hour before implant placement

Also known as: Placebo oral tablets (for Amoxicillin)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requirement for dental implant placement
• Over 18 years of age

You may not qualify if:

• Immunosuppressed or immunocompromised
• Affected by not controlled diabetes
• Serious or severe systemic disease (ASA classification \> 2)
• Previous radiotherapy to the head or neck area
• Ongoing acute or chronic infection in the oral cavity
• Ongoing treatment with antibiotics
• Hypersensitivity to penicillin
• Previous or ongoing treatment with bisphosphonates
• In need of major bone augmentation
• Planned direct loading or early loading (within 2 weeks) of the implant

Sponsors & Collaborators

• Malmö University: lead

Study Sites (1)

Malmö university

Malmo, 20506, Sweden

Location

Related Publications (1)

• Momand P, Becktor JP, Naimi-Akbar A, Tobin G, Gotrick B. Effect of antibiotic prophylaxis in dental implant surgery: A multicenter placebo-controlled double-blinded randomized clinical trial. Clin Implant Dent Relat Res. 2022 Feb;24(1):116-124. doi: 10.1111/cid.13068. Epub 2022 Jan 24.

  PMID: 35075765 DERIVED

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bengt Götrick

  Malmö University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The tablets corresponding to each patient is packed in a container by the manufacturer of the trial drug. Each drug container is labeled by a code number (1-1000) and the contents of the containers are distributed according to a randomization list with block size 6. Randomization is thus carried out by the manufacturer, independent of investigator and participating clinicians.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Randomized, placebo-controlled trial

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 26, 2018
• Study Start: January 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: August 10, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)