NCT06177119

Brief Summary

This randomized clinical trial aimed to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 31, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
11.5 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 11, 2023

Last Update Submit

December 11, 2023

Conditions

Periodontitis

Keywords

periodontitisscaling and root planingmetronidazoleamoxicillintreatmentmicrobiota

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm.

    12 months

Secondary Outcomes (23)

  • Number of sites with PD ≥ 5 mm.

    Baseline, 3, 6 and 12 months.

  • Number of sites with PD ≥ 6 mm.

    Baseline, 3, 6 and 12 months.

  • Number of sites with PD ≥ 7 mm.

    Baseline, 3, 6 and 12 months.

  • Reduction in the number of sites with PD ≥ 5 mm.

    Baseline, 3, 6 and 12 months.

  • Reduction in the number of sites with PD ≥ 6 mm.

    Baseline, 3, 6 and 12 months.

  • +18 more secondary outcomes

Study Arms (2)

Test 1

EXPERIMENTAL

Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session

Procedure: Scaling and root planingDrug: Placebos after SRPDrug: Metronidazole during SRPDrug: Amoxicillin during SRP

Test 2

EXPERIMENTAL

Scaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 14 days.

Procedure: Scaling and root planingDrug: Placebos during SRPDrug: Metronidazole after SRPDrug: Amoxicillin after SRP

Interventions

Scaling and root planingPROCEDURE

SRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.

Also known as: SRP
Test 1Test 2
Placebos during SRPDRUG

Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning with the first SRP session.

Test 2
Placebos after SRPDRUG

Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning after the last SRP session.

Test 1
Metronidazole during SRPDRUG

Metronidazole 400 mg, thrice a day for 14 days, beginning with the first SRP session.

Test 1
Amoxicillin during SRPDRUG

Amoxicillin 500 mg, thrice a day for 14 days, beginning with the first SRP session.

Test 1
Metronidazole after SRPDRUG

Metronidazole 400 mg, thrice a day for 14 days, beginning after the last SRP session.

Test 2
Amoxicillin after SRPDRUG

Amoxicillin 500 mg, thrice a day for 14 days, beginning after the last SRP session.

Test 2

Eligibility Criteria

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

You may qualify if:

  • years of age;
  • at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction);
  • a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm;
  • at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).

You may not qualify if:

  • pregnancy;
  • breastfeeding;
  • current smoking and former smoking within the past 5 years;
  • systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
  • scaling and root planing in the previous 6 months;
  • antibiotic therapy in the previous 6 months;
  • long-term intake of anti-inflammatory medications;
  • need for antibiotic pre-medication for routine dental therapy;
  • use of orthodontic appliances;
  • extensive dental prosthetic rehabilitation;
  • allergy to metronidazole and/or amoxicillin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guarulhos

Guarulhos, São Paulo, 07023-070, Brazil

Location

Related Publications (10)

  • Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.

    PMID: 29926490BACKGROUND

  • Feres M, Retamal-Valdes B, Faveri M, Duarte P, Shibli J, Soares GMS, Miranda T, Teles F, Goodson M, Hasturk H, Van Dyke T, Ehmke B, Eickholz P, Schlagenhauf U, Meyle J, Koch R, Kocher T, Hoffmann T, Kim TS, Kaner D, Figueiredo LC, Doyle H. Proposal of a Clinical Endpoint for Periodontal Trials: The Treat-to-Target Approach. J Int Acad Periodontol. 2020 Apr 1;22(2):41-53.

    PMID: 32224549BACKGROUND

  • Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol 2000. 2015 Feb;67(1):131-86. doi: 10.1111/prd.12075.

    PMID: 25494600RESULT

  • Feres M, Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Figueiredo LC. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Dec;39(12):1149-58. doi: 10.1111/jcpe.12004. Epub 2012 Sep 27.

    PMID: 23016867RESULT

  • Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Wang X, Figueiredo LC, Feres M. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a secondary analysis of microbiological results from a randomized clinical trial. J Clin Periodontol. 2014 Apr;41(4):366-76. doi: 10.1111/jcpe.12217.

    PMID: 24834504RESULT

  • Faveri M, Figueiredo LC, Feres M. Treatment of chronic periodontitis may be improved by the adjunctive use of systemic metronidazole. J Evid Based Dent Pract. 2014 Jun;14(2):70-2. doi: 10.1016/j.jebdp.2014.04.025. Epub 2014 Apr 12. No abstract available.

    PMID: 24913531RESULT

  • Feres M, Faveri M, Figueiredo LC, Teles R, Flemmig T, Williams R, Lang NP. Group B. Initiator paper. Non-surgical periodontal therapy: mechanical debridement, antimicrobial agents and other modalities. J Int Acad Periodontol. 2015 Jan;17(1 Suppl):21-30. No abstract available.

    PMID: 25764587RESULT

  • Borges I, Faveri M, Figueiredo LC, Duarte PM, Retamal-Valdes B, Montenegro SCL, Feres M. Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial. J Clin Periodontol. 2017 Aug;44(8):822-832. doi: 10.1111/jcpe.12721. Epub 2017 Jul 26.

    PMID: 28303587RESULT

  • Teughels W, Feres M, Oud V, Martin C, Matesanz P, Herrera D. Adjunctive effect of systemic antimicrobials in periodontitis therapy: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:257-281. doi: 10.1111/jcpe.13264.

    PMID: 31994207RESULT

  • Feres M, Retamal-Valdes B, Fermiano D, Faveri M, Figueiredo LC, Mayer MPA, Lee JJ, Bittinger K, Teles F. Microbiome changes in young periodontitis patients treated with adjunctive metronidazole and amoxicillin. J Periodontol. 2021 Apr;92(4):467-478. doi: 10.1002/JPER.20-0128. Epub 2020 Oct 12.

    PMID: 32844406RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Marcelo Faveri, Professor

    University of Guarulhos

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 20, 2023

Study Start

January 31, 2012

Primary Completion

July 1, 2012

Study Completion

December 31, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)