Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis

NCT02969928 | Completed Phase 2 Results

• 1 other identifier: AmxMetClmCFA
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).

Conditions

Aggressive Periodontitis

Keywords

Full-mouth ultrasonic debridement; Clarithromycin; Amoxicillin; Metronidazole

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Level (CAL)

  Evaluate the difference between baseline and 6 months CAL measures.

  Baseline, 3 and 6 months

Secondary Outcomes (2)

• Change in Probing Depth (PB)

  Baseline, 3 and 6 months

• Change in Bleeding on Probe (BoP)

  Baseline, 3 and 6 months

Other Outcomes (2)

• Compliance

  One week post treatment

• Adverse Effects That May be Related to Antibiotic Treatment

  One week post treatment

Study Arms (2)

Amoxicillin and Metronidazole

ACTIVE COMPARATOR

In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.

Procedure: Full-mouth ultrasonic debridement; Drug: Amoxicillin; Drug: Metronidazole

Clarithromycin

EXPERIMENTAL

In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.

Procedure: Full-mouth ultrasonic debridement; Drug: Clarithromycin

Interventions

Full-mouth ultrasonic debridement PROCEDURE

Full-mouth ultrasonic debridement will be performed in order to treat diseased sites

Also known as: Periodontal debridement

Amoxicillin and Metronidazole; Clarithromycin

Clarithromycin DRUG

Administration of Clarithromycin 500mg bid for 7 days

Also known as: Biaxin

Clarithromycin

Amoxicillin DRUG

Administration of Amoxicillin 500mg tid for 7 days.

Also known as: Amoxil

Amoxicillin and Metronidazole

Metronidazole DRUG

Administration of Metronidazole 400mg tid for 7 days.

Also known as: Flagyl

Amoxicillin and Metronidazole

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of GAgP (AAP, 1999);
• presence of ≥20 teeth;
• presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to other two non-contiguous teeth);
• good general health;
• ≤ 35 years old; and
• agree to participate in the study and sign a written informed consent. All subjects will be individually informed about the objectives, probable risks and benefits of the protocol treatment (according to Resolution nº196 of October 1996 and to the Professional Code of Dental Ethics - 179/93).

You may not qualify if:

• pregnancy or lactating;
• suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease;
• took antimicrobials in the previous 6 months;
• taking long-term anti-inflammatory drugs;
• previous periodontal treatment within the last 12 months;
• smokers.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

College of Dentistry - São José dos Campos, Sao Paulo State University

São José dos Campos, São Paulo, 12245-310, Brazil

Location

Related Publications (4)

• Pradeep AR, Kathariya R. Clarithromycin, as an adjunct to non surgical periodontal therapy for chronic periodontitis: a double blinded, placebo controlled, randomized clinical trial. Arch Oral Biol. 2011 Oct;56(10):1112-9. doi: 10.1016/j.archoralbio.2011.03.021. Epub 2011 May 6.

  PMID: 21529775 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

• 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

• Araujo CF, Andere NMRB, Castro Dos Santos NC, Mathias-Santamaria IF, Reis AA, de Oliveira LD, Jardini MAN, Casarin RCV, Santamaria MP. Two different antibiotic protocols as adjuncts to one-stage full-mouth ultrasonic debridement to treat generalized aggressive periodontitis: A pilot randomized controlled clinical trial. J Periodontol. 2019 Dec;90(12):1431-1440. doi: 10.1002/JPER.18-0399. Epub 2019 Jul 16.

  PMID: 31257591 DERIVED

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Periodontal Debridement; Clarithromycin; Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr Mauro Pedrine Santamaria
• Organization: São Paulo State University - Unesp

mauro.santamaria@unesp.br

+5516981937777

Study Officials

• Mauro P Santamaria, PhD

  Universidade Estadual Paulista Júlio de Mesquita Filho

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 21, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 28, 2021
• Results First Posted: September 7, 2020

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)