NCT03564301

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
Last Updated

April 28, 2021

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

May 19, 2018

Last Update Submit

April 24, 2021

Conditions

Peri-Implantitis

Keywords

Peri-implantitisantibioticsMetronidazolenon- surgical treatment

Outcome Measures

Primary Outcomes (1)

  • Change in probing depth

    Probing depth is the distance from the gingival margin to the bottom of the periodontal pocket (junctional epithelium). It is measured with a millimetric probe CP15 Hu-Friedy UNC at six points in each implant (mesial, distal and medial in buccal and lingual).

    baseline, 2 and 6 months after treatment

Secondary Outcomes (6)

  • Recession

    baseline, 2 and 6 months after treatment

  • Attachment level

    baseline, 2 and 6 months after treatment

  • Bleeding Index

    baseline, 2 and 6 months after treatment

  • Peri-implant bone loss.

    baseline, 2 and 6 months after treatment

  • Microbiological variable

    baseline and 6 months after treatment

  • +1 more secondary outcomes

Study Arms (2)

Metronidazole 250mg

ACTIVE COMPARATOR

Systemic antibiotic: Metronidazole 250mg , 2 capsules three times a day, for 7 days.

Drug: Metronidazole 250 MG

Placebo

PLACEBO COMPARATOR

Placebo: same shape, size and dosis as test

Drug: Placebo oral capsule

Interventions

Placebo oral capsuleDRUG

Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient.

Placebo
Metronidazole 250 MGDRUG

Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the antibiotic to be taken during the following days will be given to the patient.

Metronidazole 250mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years.
  • Presence of at least 1 implant diagnosed with peri-implantitis (Presence of BOP and/or suppuration, with 2 mm of detectable bone loss after initial remodeling, and PD≥ 4 mm as defined by Daubert et al. 2015).
  • Absence of implant mobility.
  • History of taking systemic antibiotics in the preceding 3 months.
  • No systemic pathology that contraindicated the completion of treatment.
  • The patient understands the treatment and willing to comply.
  • The patient is willing to give written informed consent and can do

You may not qualify if:

  • Pregnant.
  • Metronidazole allergies
  • Patients on treatment with bisphosphonates.
  • Uncontrolled periodontal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of periodontology, faculty of Odontology

Santiago de Compostela, Coruña, 15782, Spain

Location

Related Publications (6)

  • Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.

    PMID: 26285807RESULT

  • Mombelli A, Lang NP. Antimicrobial treatment of peri-implant infections. Clin Oral Implants Res. 1992 Dec;3(4):162-8. doi: 10.1034/j.1600-0501.1992.030402.x.

    PMID: 1298430RESULT

  • Renvert S, Samuelsson E, Lindahl C, Persson GR. Mechanical non-surgical treatment of peri-implantitis: a double-blind randomized longitudinal clinical study. I: clinical results. J Clin Periodontol. 2009 Jul;36(7):604-9. doi: 10.1111/j.1600-051X.2009.01421.x.

    PMID: 19538334RESULT

  • Renvert S, Roos-Jansaker AM, Claffey N. Non-surgical treatment of peri-implant mucositis and peri-implantitis: a literature review. J Clin Periodontol. 2008 Sep;35(8 Suppl):305-15. doi: 10.1111/j.1600-051X.2008.01276.x.

    PMID: 18724858RESULT

  • Persson GR, Samuelsson E, Lindahl C, Renvert S. Mechanical non-surgical treatment of peri-implantitis: a single-blinded randomized longitudinal clinical study. II. Microbiological results. J Clin Periodontol. 2010 Jun;37(6):563-73. doi: 10.1111/j.1600-051X.2010.01561.x.

    PMID: 20507380RESULT

  • Blanco C, Pico A, Dopico J, Gandara P, Blanco J, Linares A. Adjunctive benefits of systemic metronidazole on non-surgical treatment of peri-implantitis. A randomized placebo-controlled clinical trial. J Clin Periodontol. 2022 Jan;49(1):15-27. doi: 10.1111/jcpe.13564. Epub 2021 Oct 28.

    PMID: 34713471DERIVED

Related Links

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
It will not be possible to know which patient will correspond the prescription of the antibiotic or the placebo until the end of treatment. One of the researchers will be masked and will deliver the boxes with the placebo or the antibiotic according to the result of randomization. He will be different from the researcher who perform the treatment. This means that the treatment group will be masked to patients and dentists.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: PLACEBO-CONTROLLED CLINICAL TRIAL IN HUMAN
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 19, 2018

First Posted

June 20, 2018

Study Start

March 3, 2018

Primary Completion

March 1, 2020

Study Completion

December 22, 2020

Last Updated

April 28, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)