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NCT03564301

Metronidazole as an Adjunct of Non- Surgical Treatment of Peri-implantitis

Completed Phase 4 Last updated 28 April 2021
What this trial tests

Phase 4 trial testing Placebo oral capsule in Peri-Implantitis in 20 participants. Completed in 22 December 2020.

Timeline
3 March 2018
Primary endpoint
1 March 2020
22 December 2020

Quick facts

Lead sponsorJuan Blanco Carrión
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment20
Start date3 March 2018
Primary completion1 March 2020
Estimated completion22 December 2020
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Juan Blanco Carrión

Who can join

18 and older, any sex, with Peri-Implantitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The use of systemic antibiotics as and adjunct to non-surgical peri-implant therapy may be an improvement in comparison to these therapies alone. The primary objective is the evaluation of significant changes in probing pocket depth between non-surgical with or without antibiotics. This is a controlled-placebo clinical trial design. Patients with osseointegrated oral implants will be selected and recruited from a university clinic. Oral hygiene instruction and non-surgical debridement at implants will be provided with ultrasonic devices and immediately after, patients will be prescribed: Group Control: A placebo with the same characteristics as the antibiotic Group Test: Systemic antibiotics (Metronidazole 250mg, 2 capsules three times a day, for 7 days Three and six months after non-surgical treatment, clinical parameters will be registered and radiographs compared using reproducible landmarks. Any adverse event will be also recorded.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Adjunctive benefits of systemic metronidazole on non-surgical treatment of peri-implantitis. A randomized placebo-controlled clinical trial.
    Blanco C, Pico A, Dopico J, Gándara P, et al · · 2022 · cited 45× · PMID 34713471 · DOI 10.1111/jcpe.13564
  2. The systemic impact of non-surgical treatment of peri-implantitis with or without adjunctive systemic metronidazole: Secondary analysis of a randomized clinical trial.
    Liñares A, Dopico J, Blanco C, Pico A, et al · · 2024 · cited 1× · PMID 39093380 · DOI 10.1111/clr.14339

Verify or expand the search:

Other trials of Metronidazole 250 MG

Trials testing the same drug.

Other recruiting trials for Peri-Implantitis

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03564301.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing