Amoxicillin and Metronidazole During Periodontal Treatment

NCT02954393 | Unknown

• 1 other identifier: CAAE: 32465714.4.1001.5506
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.

Conditions

Chronic Periodontitis

Keywords

Periodontal disease; Metronidazole; Amoxicillin; Scaling and root planing; Healing phase

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months

  12 months

Secondary Outcomes (24)

• 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.

Study Arms (3)

Control

PLACEBO COMPARATOR

Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.

Procedure: Scaling and root planing; Drug: Placebos active phase; Drug: Placebos healing phase

Active phase

ACTIVE COMPARATOR

Scaling and root planing + Metronidazole active phase (400 mg/thrice a day,TID) + Amoxicillin active phase (500 mg/ TID) for 14 days and Placebos healing phase TID for 14 days.

Procedure: Scaling and root planing; Drug: Metronidazole active phase; Drug: Amoxicillin active phase; Drug: Placebos healing phase

Healing phase

ACTIVE COMPARATOR

Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Metronidazole healing phase (400 mg/TID) + Amoxicillin healing phase (500 mg/TID) for 14 days.

Procedure: Scaling and root planing; Drug: Metronidazole healing phase; Drug: Amoxicillin healing phase; Drug: Placebos active phase

Interventions

Scaling and root planing PROCEDURE

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

Active phase; Control; Healing phase

Metronidazole active phase DRUG

Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).

Also known as: MTZ 1

Active phase

Metronidazole healing phase DRUG

Metronidazole 400 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).

Also known as: MTZ 2

Healing phase

Amoxicillin active phase DRUG

Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).

Also known as: AMX 1

Active phase

Amoxicillin healing phase DRUG

Amoxicillin 500 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).

Also known as: AMX 2

Healing phase

Placebos active phase DRUG

Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).

Also known as: P 1

Control; Healing phase

Placebos healing phase DRUG

Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).

Also known as: P 2

Active phase; Control

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥35 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 an 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.

Sponsors & Collaborators

• Belén Retamal-Valdes: lead

Study Sites (2)

University of Guarulhos

Guarulhos, São Paulo, 07023-070, Brazil

Location

University of São Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (20)

• Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.

  PMID: 10863370 BACKGROUND

• 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: 23016867 BACKGROUND

• 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: 25494600 BACKGROUND

• Haffajee AD, Patel M, Socransky SS. Microbiological changes associated with four different periodontal therapies for the treatment of chronic periodontitis. Oral Microbiol Immunol. 2008 Apr;23(2):148-57. doi: 10.1111/j.1399-302X.2007.00403.x.

  PMID: 18279183 BACKGROUND

• Herrera D, Sanz M, Jepsen S, Needleman I, Roldan S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol. 2002;29 Suppl 3:136-59; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.8.x.

  PMID: 12787214 BACKGROUND

• Keestra JA, Grosjean I, Coucke W, Quirynen M, Teughels W. Non-surgical periodontal therapy with systemic antibiotics in patients with untreated chronic periodontitis: a systematic review and meta-analysis. J Periodontal Res. 2015 Jun;50(3):294-314. doi: 10.1111/jre.12221. Epub 2014 Aug 21.

  PMID: 25142259 BACKGROUND

• Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16.

  PMID: 15643744 BACKGROUND

• Matuliene G, Pjetursson BE, Salvi GE, Schmidlin K, Bragger U, Zwahlen M, Lang NP. Influence of residual pockets on progression of periodontitis and tooth loss: results after 11 years of maintenance. J Clin Periodontol. 2008 Aug;35(8):685-95. doi: 10.1111/j.1600-051X.2008.01245.x. Epub 2008 Jul 23.

  PMID: 18549447 BACKGROUND

• Matuliene G, Studer R, Lang NP, Schmidlin K, Pjetursson BE, Salvi GE, Bragger U, Zwahlen M. Significance of Periodontal Risk Assessment in the recurrence of periodontitis and tooth loss. J Clin Periodontol. 2010 Feb;37(2):191-9. doi: 10.1111/j.1600-051X.2009.01508.x. Epub 2009 Dec 21.

  PMID: 20041980 BACKGROUND

• Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.

  PMID: 20447259 BACKGROUND

• Mestnik MJ, Feres M, Figueiredo LC, Soares G, Teles RP, Fermiano D, Duarte PM, Faveri M. The effects of adjunctive metronidazole plus amoxicillin in the treatment of generalized aggressive periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Oct;39(10):955-61. doi: 10.1111/j.1600-051X.2012.01932.x. Epub 2012 Aug 6.

  PMID: 22882646 BACKGROUND

• Sgolastra F, Gatto R, Petrucci A, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis. J Periodontol. 2012 Oct;83(10):1257-69. doi: 10.1902/jop.2012.110625. Epub 2012 Feb 14.

  PMID: 22220767 BACKGROUND

• Socransky SS, Haffajee AD. Dental biofilms: difficult therapeutic targets. Periodontol 2000. 2002;28:12-55. doi: 10.1034/j.1600-0757.2002.280102.x. No abstract available.

  PMID: 12013340 BACKGROUND

• Socransky SS, Haffajee AD. Periodontal microbial ecology. Periodontol 2000. 2005;38:135-87. doi: 10.1111/j.1600-0757.2005.00107.x. No abstract available.

  PMID: 15853940 BACKGROUND

• Socransky SS, Haffajee AD, Cugini MA, Smith C, Kent RL Jr. Microbial complexes in subgingival plaque. J Clin Periodontol. 1998 Feb;25(2):134-44. doi: 10.1111/j.1600-051x.1998.tb02419.x.

  PMID: 9495612 BACKGROUND

• Socransky SS, Haffajee AD, Smith C, Dibart S. Relation of counts of microbial species to clinical status at the sampled site. J Clin Periodontol. 1991 Nov;18(10):766-75. doi: 10.1111/j.1600-051x.1991.tb00070.x.

  PMID: 1661305 BACKGROUND

• Socransky SS, Smith C, Martin L, Paster BJ, Dewhirst FE, Levin AE. "Checkerboard" DNA-DNA hybridization. Biotechniques. 1994 Oct;17(4):788-92.

  PMID: 7833043 BACKGROUND

• Teles RP, Haffajee AD, Socransky SS. Microbiological goals of periodontal therapy. Periodontol 2000. 2006;42:180-218. doi: 10.1111/j.1600-0757.2006.00192.x. No abstract available.

  PMID: 16930311 BACKGROUND

• Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.

  PMID: 33197289 DERIVED

• Feres M, Retamal-Valdes B, Mestnik MJ, de Figueiredo LC, Faveri M, Duarte PM, Fritoli A, Faustino E, Souto MLS, de Franco Rodrigues M, Giudicissi M, Nogueira BCL, Saraiva L, Romito GA, Pannuti CM. The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial. Trials. 2018 Mar 27;19(1):201. doi: 10.1186/s13063-018-2540-8.

  PMID: 29587808 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Periodontal Diseases

Interventions

Tooth Exfoliation; Root Planing; P-2

Condition Hierarchy (Ancestors)

Periodontitis; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Magda Feres, Professor

  University of Guarulhos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, MSc, PhD Student

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 3, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)